[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"amyotrophic-lateral-sclerosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:amyotrophic-lateral-sclerosis":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,128,0,25,[9,43,73,99,151,174,194,209,238,261,285,304,328,348,370,392,417,445,465,489,517,544,577,605,625],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100617698","phase-3-pridopidine-phase-3-study-to-evaluate-efficacy-and-safety-in-als-100617698",false,"NCT07322003","Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS","A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants With Amyotrophic Lateral Sclerosis","PREVAiLS","Key Inclusion Criteria:\n\n* Definite ALS or Probable ALS using the El Escorial criteria.\n* Symptom onset of ≤18 months at screening.\n* Slow vital capacity (SVC) greater or equal to 60% predicted.\n* Treatment Research Initiative to Cure ALS (TRICALS) Risk Profile Calculator score, based on the European Network for the Cure of ALS (ENCALS) survival prediction model, in the range of -6 to -2, inclusive, at screening.\n* Able to swallow a capsule.\n\nKey Exclusion Criteria:\n\n* Presence of tracheostomy or permanent assisted ventilation.\n* Clinically significant heart disease, clinically significant history of arrhythmia, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia, or presence of left bundle branch block.\n* Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide informed consent and participate in the study.\n* Clinically significant and\u002For unstable medical condition (other than ALS) that may either pose a clinically meaningful risk to the participant and\u002For to study completion.\n* Use of medications that prolong QT interval.\n* Previous treatment with pridopidine, gene therapy, or antisense oligonucleotides.\n* Confirmed mutation in the SOD1, FUS or C9orf72 gene.\n* Pregnancy.","ALL","18 Years","80 Years",{"count":22,"type":23},500,"ESTIMATED","INTERVENTIONAL",[26],"PHASE3","The goal of this clinical trial is to learn if the drug pridopidine works to treat amyotrophic lateral sclerosis in adults. It will also help to learn about the safety of pridopidine. The main question it aims to answer is:\n\nDoes pridopidine slow disease progression of ALS?\n\nResearchers will compare pridopidine to a placebo (a look-alike substance that contains no drug) to see if pridopidine works to treat ALS.\n\nParticipants will:\n\nTake pridopidine or a placebo by mouth every day for 48 weeks. Afterwards, all participants will take pridopidine for another 48 weeks.\n\nVisit the clinic once every 1-3 months for checkups and tests",[29],"Amyotrophic Lateral Sclerosis","RECRUITING","2026-07-01",{"date":33,"type":34},"2026-07-02","ACTUAL",{"date":36,"type":34},"2026-02-01",{"date":38,"type":23},"2029-03",{"name":40,"class":41},"Prilenia","INDUSTRY",32,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100303052","investigating-complex-neurodegenerative-disorders-related-to-amyotrophic-lateral-sclerosis-and-frontotemporal-dementia-100303052","NCT03225144","Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia","* INCLUSION CRITERIA:\n\nPatients will be included if they\n\n* Are age 18 or older\n* Have been given a diagnosis by a neurologist of frontotemporal dementia, primary progressive aphasia, semantic dementia, motor neuron disorder, amyotrophic lateral sclerosis, progressive bulbar palsy, corticobasal syndrome, Huntington disease or other related adult-onset neurodegenerative disorder OR\n* Carry a mutation in a gene that causes familial ALS or FTD\n\nEXCLUSION CRITERIA:\n\nPatients will be excluded if they\n\n* Have other major neurological or medical diseases that may cause progressive weakness or cognitive dysfunction, such as structural brain or spinal cord disease, metabolic diseases, paraneoplastic syndromes, infectious diseases, peripheral neuropathy or radiculopathy or other significant neurological abnormalities.\n* Have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe\n* Require daytime ventilator support at the time of study entry\n* Are unable to travel to NIH\n* Patients with pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, or shrapnel fragments, metal fragments in the eye) will not be excluded but will not undergo magnetic resonance imaging.\n* Patients with tattoos above the neck or permanent make up will be excluded from undergoing 7T MRI.","110 Years",{"count":51,"type":23},360,"OBSERVATIONAL","Background:\n\nNeurodegenerative disorders can lead to problems in movement or memory. Some can cause abnormal proteins to build up in brain cells. Researchers want to understand whether these diseases have related causes or risk factors.\n\nObjective:\n\nTo test people with movement or thinking and memory problems to see if they are eligible for research studies.\n\nEligibility:\n\nPeople ages 18 and older with a neurodegenerative disorder associated with accumulation of TDP-43 or Tau proteins\n\nDesign:\n\nParticipants will have a screening visit. This may take place over 2-3 days. Tests include:\n\nMedical history\n\nPhysical exam\n\nQuestions about behavior and mood\n\nTests of memory, attention, concentration, and thinking\n\nMovement measurement. The speed at which participants can stand up from a chair, tap their finger and foot, and walk a short distance will be measured. Some movements will be videotaped. They will be videotaped while they speak and read a paragraph.\n\nBlood tests. This might include genetic testing.\n\nLung and breathing tests\n\nMRI. They will lie on a table that slides into a cylinder that takes pictures of the body. Some participants will get a dye through IV.\n\nElectromyography. A thin needle will be inserted into the muscles to measure electrical signals.\n\nNerve tests. Small electrodes on the skin record muscle and nerve activity.\n\nA small piece of skin may be removed.\n\nA skin or blood sample may be taken to create stem cells.\n\nOptional lumbar puncture. A needle will be inserted into the space between the bones of the back to collect fluid.\n\nIf participants are not eligible for current studies, they may be contacted in the future.",[55,29,56],"Frontotemporal Dementia","Progressive Supranuclear Palsy",[58,56,59,55,60,61],"TDP-43","Motor Neuron Disease","Corticobasal Syndrome","Natural History","2026-06-27",{"date":64,"type":34},"2026-06-30",{"date":66,"type":34},"2017-10-11",{"date":68,"type":23},"2027-10-30",{"name":70,"class":71},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH",1,{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":24,"phases":84,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":4},"100644782","phase-1-function-als-aiming-to-restore-unc13a-function-in-people-living-with-als-100644782","NCT07674667","FUNCtion ALS: Aiming to Restore UNC13A Function in People Living With ALS","A Randomized, Double-Blind, Placebo-Controlled, Phase 1 \u002F 2 Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Exploratory Efficacy of TRCN-1023 Administered by Intrathecal Injections to Adult People Living With Amyotrophic Lateral Sclerosis","FUNCtion ALS","Key Inclusion Criteria:\n\n* Adults aged 18 to 75 years\n* Diagnosis of ALS (clinically definite, clinically probable, or clinically probable laboratory supported)\n* ALS symptoms began within the past 24 months\n* Able to perform breathing tests: slow vital capacity (SVC) with consistent results, with breathing capacity of at least 60% of the expected value\n* Able and willing to meet all study requirements, including travel to the study site, brain magnetic resonance imaging (MRI) scans, lumbar punctures, and blood draws\n* Able and willing to use wearable sensors and complete speech assessments at home\n* On a stable dose of approved ALS medication for at least 4 weeks prior to screening\n* Capable of providing informed consent\n\nKey Exclusion Criteria:\n\n* Carries a confirmed SOD1 or FUS gene mutation\n* Has a tracheostomy or requires continuous assisted ventilation more than 22 hours per day during the preceding 3 months before the first Screening Visit\n* Has a contraindication to brain MRI (e.g., pacemaker, metal implants)\n* Has a contraindication to lumbar puncture or spinal injection (e.g., blood clotting disorders, certain blood thinners, signs of increased pressure in the brain)\n* Has significant abnormal liver, kidney, or blood test results\n* Is currently enrolled in another clinical trial or has received an investigational treatment within the past 4 weeks\n* Has previously received gene therapy, stem cell therapy, or another Antisense oligonucleotide (ASO) treatment\n* Has a clinically significant condition other than ALS that could interfere with study participation","75 Years",{"count":83,"type":23},30,[85,86],"PHASE1","PHASE2","The FUNCtion Amyotrophic Lateral Sclerosis (ALS) trial is a randomized, double-blind, placebo-controlled Phase 1\u002F2 trial to evaluate the safety and tolerability of TRCN-1023 in adults living with ALS. TRCN-1023 is an investigational medicine given as a single injection into the fluid surrounding the spine (intrathecal injection). The trial will also assess how the body processes the drug and whether it shows early signs of benefit over 24 weeks.",[29],"NOT_YET_RECRUITING","2026-06-24",{"date":92,"type":34},"2026-06-29",{"date":94,"type":23},"2026-07",{"date":96,"type":23},"2027-09",{"name":98,"class":41},"Trace Neuroscience, Inc.",{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":24,"phases":108,"briefSummary":110,"conditions":111,"keywords":135,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":150},"100270060","neurologic-stem-cell-treatment-study-100270060","NCT02795052","Neurologic Stem Cell Treatment Study","Neurologic Bone Marrow Derived Stem Cell Treatment Study","NEST","Inclusion Criteria:\n\n1. Have documented functional damage to the central or peripheral nervous system unlikely to improve with present standard of care.\n2. Be at least 6 months post-onset of the disease.\n3. If under current medical therapy (pharmacologic or surgical treatment) for the condition be considered stable on that treatment and unlikely to have reversal of the associated neurologic functional damage as a result of the ongoing pharmacologic or surgical treatment.\n4. In the estimation of Dr. Weiss and the neurologists have the potential for improvement with BMSC treatment and be at minimal risk of any potential harm from the procedure.\n5. Be over the age of 18 and capable of providing informed consent.\n6. Be medically stable and able to be medically cleared by their primary care physician or a licensed primary care practitioner for the procedure. Medical clearance means that in the estimation of the primary care practitioner, the patient can reasonably be expected to undergo the procedure without significant medical risk to health.\n\nExclusion Criteria:\n\n1. All patients must be capable of an adequate neurologic examination and evaluation to document the pathology. This will include the ability to cooperate with the exam.\n2. Patients must be capable and willing to undergo follow up neurologic exams with the sub-investigators or their own neurologists as outlined in the protocol.\n3. Patients must be capable of providing informed consent.\n4. In the estimation of Dr. Weiss the BMSC collection and treatment will not present a significant risk of harm to the patient's general health or to their neurologic function. .\n5. Patients who are not medically stable or who may be at significant risk to their health undergoing the procedure will not be eligible.\n6. Women of childbearing age must not be pregnant at the time of treatment and should refrain from becoming pregnant for 3 months post treatment.",{"count":22,"type":23},[109],"NA","This is a human clinical study involving the isolation of autologous bone marrow derived stem cells (BMSC) and transfer to the vascular system and inferior 1\u002F3 of the nasal passages in order to determine if such a treatment will provide improvement in neurologic function for patients with certain neurologic conditions. http:\u002F\u002Fmdstemcells.com\u002Fnest\u002F",[112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,56,127,29,128,129,130,131,55,132,133,134],"Neurologic Disorders","Nervous System Diseases","Neurodegenerative Diseases","Neurological Disorders","Stroke","Traumatic Brain Injury","Cadasil","Chronic Traumatic Encephalopathy","Cerebral Infarction","Cerebral Ischemia","Cerebral Stroke","Cerebral Hemorrhage","Parkinson","Multi-System Degeneration","MSA - Multiple System Atrophy","ALS","Neuropathy","Diabetic Neuropathies","Alzheimer Disease","Dementia","Lewy Body Disease","Cognitive Impairment","Lewy Body Variant of Alzheimer Disease",[136,137,116,117,138,139,128,140,121,133,131,141],"Neurologic Disease","Cerebral Vascular Accident","Multiple Sclerosis","Parkinsons Disease","Diabetic Neuropathy","Neurodegeneration",{"date":143,"type":34},"2026-06-26",{"date":145,"type":34},"2016-06",{"date":147,"type":23},"2028-07-31",{"name":149,"class":41},"MD Stem Cells",3,{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":127,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":24,"phases":160,"briefSummary":161,"conditions":162,"keywords":163,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":173},"100615038","phase-1-study-is-to-assess-the-safety-and-tolerability-of-vtx-002-in-participants-with-als-100615038","NCT07287397","Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS","Phase 1\u002F2 Investigation of Novel Experimental Regimen in Amyotrophic Lateral Sclerosis (Pioneer-ALS): An Open-Label, Uncontrolled, Multicenter Study to Assess the Safety and Tolerability of Two Doses of VTx-002","Key Inclusion Criteria:\n\n1. Capable of, and willing to, provide written informed consent and comply with study procedures, including visits to the study site and visit requirements\n2. Male or female ≥ 18 years of age\n3. Has a diagnosis of ALS according to the El Escorial criteria (Brooks, et al., 2000) (probable, laboratory results supported; clinically probable, clinically definite)\n4. Confirmed absence of ALS caused by FUS and SOD1 gene mutations confirmed by laboratory tests.\n5. A maximum of 18 months since first appearance of weakness (e.g., limb weakness, dysarthria, dysphagia, shortness of breath)\n6. Erect (seated) SVC % predicted ≥ 80% at Screening\n7. Treatment Research Initiative to Cure ALS (TRICALS) risk score between -2 and -6 at Screening\n8. Has a reliable caregiver\u002Fpartner\u002Flegal representative willing and able to support the participant in participation in the study and to give informed consent on behalf of the participant in the case that disease progression prevents the participant of giving consent (local legal rules will apply).\n9. Treatment with riluzole and\u002For edaravone is allowed if treatment was started and has remained at a stable dose for at least 2 weeks (riluzole) or one treatment cycle (edaravone) before the Screening visit\n10. Women of childbearing potential (WOCBP) and male participants with female partners who are WOCBP must agree to use highly effective contraception during and after the study. WOCBP cannot be pregnant or breastfeeding\n11. Women of nonchildbearing potential must be post-menopausal or surgically sterile (e.g. hysterectomy, bilateral tubal ligation, ovaries removed)\n\nKey Exclusion Criteria:\n\n1. Diagnosis of a significant CNS or peripheral nervous system disease other than ALS that may be a cause for the participant's ALS symptoms or may confound study objectives\n2. Spinal, cervical, or brain MRI\u002FMRA indicating clinically significant abnormality\n3. Presence of tracheostomy and feeding tube at Screening\n4. Contraindications to corticosteroid use (e.g. due to osteoporosis, uncontrolled blood pressure, diabetes or cholesterol).\n\n5\\. Significant concomitant disease or condition within 6 months of Screening that could pose an unacceptable safety risk to the participant or interfere with the participant's ability to comply with study procedures, e.g. heart disease, uncontrolled diabetes, liver disease, autoimmune diseases needing strong immune-suppressing drugs, cancer, etc or a current psychiatric diagnosis.\n\n6\\. Clinically significant abnormalities in laboratory test results at Screening for example poor liver or kidney function, abnormal clotting or infections such as Hepatitis or HIV\n\n7\\. Use of blood thinners (e.g., warfarin, heparin, and novel oral anticoagulants) and being unable to safely stop them before certain study procedures.\n\n8\\. Contraindications to imaging methods MRI, MRA, CT due to claustrophobia and\u002For intolerance to contrast agents.\n\n9\\. Contraindications to general anaesthesia (GA) or deep sedation\n\n10 Positive test for illegal drugs (except prescribed medications or permitted medicinal\u002Frecreational marijuana if used responsibly)\n\n11\\. Generally frail or if the Investigator deems participation in the study would not be in the best interest of the participant or is likely to prohibit further participation during the study\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply\n\n\\-",{"count":159,"type":23},12,[85,86],"PIONEER-ALS is a Phase 1\u002F2, multicenter, open-label, ascending dose, uncontrolled, first-in-human study that will evaluate the safety, tolerability and effects on clinical and biomarker endpoints of intracisternal administration of Vtx-002 in participants with Amyotrophic Lateral Sclerosis (ALS).\n\nTwo escalating dose (low dose and high dose) cohorts are planned. The duration of the study will be a maximum of 5 years and 5 weeks (265 weeks) for each participant. The screening period may last up to 5 weeks to complete screening procedures.",[29],[127],"2026-06-22",{"date":166,"type":34},"2026-06-23",{"date":168,"type":34},"2025-12-19",{"date":170,"type":23},"2027-10-15",{"name":172,"class":41},"Vector Y Therapeutics",11,{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":181,"targetDuration":4,"studyType":24,"phases":182,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":193},"100636860","phase-1-a-substudy-of-ly4256984-in-participants-with-sporadic-amyotrophic-lateral-sclerosis-100636860","NCT07571174","A Substudy of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis","A Study of Long-Term Safety, Tolerability, and Clinical Outcomes of Intrathecally Administered LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis: A Multicenter, Open-Label, Long-Term Extension of Study J6I-MC-OWAA","Participants must meet eligibility criteria in the \\[L0U-MC-OLMP\\] screening protocol before entry into the treatment study.\n\nInclusion Criteria:\n\n* Have completed the main treatment period\u002Fphase as well as any off-treatment period\u002Fphase of Study OWAA, the parent study for this ISA.\n\nExclusion Criteria:\n\n* The participant has conditions that preclude a lumbar puncture (LP), such as:\n\n  * A history of clinically significant back pain, back pathology, and\u002For back injury (for example, degenerative disease, spinal deformity, or spinal surgery) that may predispose to complications or technical difficulty with LP.\n  * Allergy to local anesthetics, such as lidocaine or its derivatives.\n  * A local infection at the intended site of the LP.\n  * Less than 100 giga per liter \\[(\\\u003C100 GI\u002FL) is equivalent to 100,000 per cubic millimeter (100,000\u002Fmm³)\\] platelets or clinically significant coagulation abnormality or significant active bleeding, or\n  * Currently receiving treatment with an anticoagulant, antiplatelet agent, or other drug that affects coagulation or platelet function. Low dose (according to local medical guidelines) aspirin is permitted.",{"count":42,"type":23},[85],"The main purpose of this study is to assess the long-term safety and tolerability of LY4256984 in participants with Amyotrophic Lateral Sclerosis (ALS). This study is a long-term extension of study J6I-MC-OWAA (NCT07100119) and is part of the OLMP (NCT07571200) master protocol that will last approximately 96 weeks.",[29],"2026-06-19",{"date":90,"type":34},{"date":188,"type":34},"2026-05-14",{"date":190,"type":23},"2029-06",{"name":192,"class":41},"Eli Lilly and Company",9,{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":201,"targetDuration":4,"studyType":24,"phases":202,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":205,"startDateStruct":206,"completionDateStruct":207,"leadSponsor":208,"locationsCount":193},"100636862","phase-1-a-master-protocol-olmp-a-study-of-ly4256984-in-participants-with-amyotrophic-lateral-sclerosis-als-100636862","NCT07571200","A Master Protocol (OLMP): A Study of LY4256984 in Participants With Amyotrophic Lateral Sclerosis (ALS)","A Master Protocol for Open-Label Extension Studies to Evaluate the Long-Term Safety and Tolerability of Interventions in Various Stages of Clinical Development in Participants With Amyotrophic Lateral Sclerosis","Participants must meet eligibility criteria below. Additional criteria are specified in the substudy to which the participant will enroll.\n\nInclusion Criteria:\n\n* Have completed an eligible parent study, as determined by the investigator. Eligible parent studies will be defined by the sponsor but will be clinical studies designed to evaluate a study intervention for the treatment of ALS.\n\n  * Note 1: To be considered a \"completer\" of a parent study, the participant must finish the main treatment period\u002Fphase of the parent study as well as any off-treatment period\u002Fphase as described in the parent study's protocol.\n  * Note 2: Visits missed in a parent study will have no impact on the completer status of a potential participant.\n\nExclusion Criteria:\n\n* During the parent study, the participant permanently or temporarily discontinued the investigational medicinal product (IMP), such that restarting the IMP would pose an unacceptable risk to the participant's safety, in the opinion of the investigator.\n* During the parent study, the participant experienced extreme ALS disease progression (for example, permanent mechanical ventilation) that poses an unacceptable risk to the participant's safety in the opinion of the investigator.\n* During the parent study, the participant developed an unresolved SAE or a medical illness (other than ALS) that, in the opinion of the investigator, precludes either continued exposure to an IMP or participation in study procedures due to an unacceptable risk to the participant's safety.",{"count":42,"type":23},[85],"Study OLMP is a master protocol that will support a collection of individual sub studies that share key design components. Participants from the originator study OWAA (NCT07100119) will be assigned to the appropriate study treatment group: Sporadic Amyotrophic Lateral Sclerosis OL01 (NCT07571174). The studies aim to evaluate the safety and tolerability of different treatments in participants with Amyotrophic Lateral Sclerosis (ALS) that will last at least 96 weeks.",[29],{"date":90,"type":34},{"date":188,"type":34},{"date":190,"type":23},{"name":192,"class":41},{"id":210,"slug":211,"hasResults":12,"nctId":212,"briefTitle":213,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":24,"phases":218,"briefSummary":219,"conditions":220,"keywords":221,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":237},"100527444","french-german-cohort-study-to-determine-factors-associated-with-weight-loss-in-amyotrophic-lateral-sclerosis-100527444","NCT06147843","French-German Cohort Study to Determine Factors Associated With Weight Loss in Amyotrophic Lateral Sclerosis","FG-CoALS","Inclusion Criteria:\n\n* Incident cases included at the time of diagnosis with a definite, probable, probable laboratory-supported, or possible ALS according to El Escorial revised criteria and Gold Coast criteria for early diagnosis.\n* Incident ALS cases identified and followed-up in the participant ALS \\& Other Motor Neuron Diseases Referral Centres: seven in France and two in Germany.\n* Patients who signed the informed consent form.\n* Adults aged \\>18 years old\n\nExclusion Criteria:\n\n* Inability to understand the requirements of the protocol.\n* Cognitive inability to sign and comprehend the informed consent form.\n* Patients who will not accept Riluzole therapy during their follow-up.",{"count":217,"type":23},1000,[109],"Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease. Studies have shown the importance of weight loss at the time of diagnosis and during the progression of the disease. However, the pathophysiological mechanisms behind weight loss remain unknown. Identifying these mechanisms could make it possible to propose an effective therapeutic strategy against weight loss for ALS patients, which could improve their survival and quality of life. In this context, the investigators are proposing an innovative multidisciplinary project aimed at structuring a large Franco-German cohort to identify the markers associated with weight loss in ALS.\n\nParticipants will undergo high quality standard care for ALS patients. In addition, participants will be asked to respond different questionnaires and blood samples will be taken for analysis to identify biological markers.",[29],[222,223,224,225,226,227,228],"Amyotrophic lateral sclerosis","Weight Loss","Genetics","Nutrition","Prognosis","Metabolomics","Inflammation",{"date":90,"type":34},{"date":231,"type":34},"2024-09-17",{"date":233,"type":23},"2029-09-30",{"name":235,"class":236},"University Hospital, Limoges","OTHER",7,{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":81,"enrollmentInfo":246,"targetDuration":4,"studyType":24,"phases":248,"briefSummary":249,"conditions":250,"keywords":251,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":260},"100641756","phase-1-a-study-of-ltx-002-in-adult-participants-with-amyotrophic-lateral-sclerosis-100641756","NCT07660614","A Study of LTX-002 in Adult Participants With Amyotrophic Lateral Sclerosis","A First-in-Human, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of Intrathecally Administered LTX-002 in Adult Participants With Amyotrophic Lateral Sclerosis","NeurALS","Inclusion Criteria:\n\n* Diagnosis of ALS per Gold Coast criteria\n* ALS symptom onset less than 36 months prior to Screening\n* Slow vital capacity ≥ 50% of predicted value\n* Body mass index ≥18 and ≤40 kg\u002Fm2\n\nExclusion Criteria:\n\n* Current evidence or history of a clinically significant medical condition that, in the Investigator's judgement, would impact the participant's safety, interpretation of study results, or place the participant at high risk of poor treatment compliance or of not completing the study\n* History of brain or spinal abnormalities on magnetic imaging (MRI) or computed tomography (CT) that might interfere with the lumbar puncture (LP), cerebrospinal fluid (CSF) circulation or safety assessments\n* Prior treatment with antisense oligonucleotide (ASO), small interfering RNA, stem cell therapy, or gene therapy for any indication\n* Tracheostomy\n* HIV, Hepatitis B or C infection (acute or chronic)\n* Presence of implanted shunt (CSF) or vascular device\n* Risk for uncontrolled bleeding\n* Pregnant or breastfeeding",{"count":247,"type":23},56,[85,86],"This study will examine what happens when patients with amyotrophic lateral sclerosis (ALS) are given an investigational medication (study drug) known as LTX-002. Specifically, the researchers will be looking at safety, tolerability (if someone has any side effects from the drug), pharmacokinetics (what the body does to the study drug) and pharmacodynamics (what the study drug does to the body). The study will also investigate the effect of the drug on indicators of the severity of ALS, such as markers in blood and in the cerebrospinal fluid (the fluid that surrounds the brain and spinal cord, CSF) and on measures of the participant's ability to move, speak, and breathe.",[29],[127],"2026-06-16",{"date":164,"type":34},{"date":255,"type":34},"2026-04-29",{"date":257,"type":23},"2031-06",{"name":259,"class":41},"Leal Therapeutics, Inc",5,{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":268,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":271,"conditions":272,"keywords":273,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":42},"100560518","assess-all-als-study-100560518","NCT06578195","ASSESS ALL ALS Study","ASSESS ALL ALS - Longitudinal Biomarker Study for Symptomatic ALS and Control Participants","Inclusion Criteria for ALS participants:\n\n1. Age 18 years or older\n2. Capable of providing informed consent\n3. Willing to follow study procedures\n4. Diagnosis of ALS by a physician\n5. Access to a smartphone, computer or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient)\n\nInclusion Criteria for control participants:\n\n1. Age 18 years or older\n2. Capable of providing informed consent\n3. Willing to follow study procedures\n4. No diagnosis of ALS , Progressive Muscular Atrophy (PMA) or Primary Lateral Sclerosis (PLS)\n5. No history of familial ALS\u002FFrontotemporal Dementia (FTD) in a close family member\\*\\* unless the participant has previously tested negative for the known causative ALS genes. Participants with a family history of singleton ALS are permitted to enroll.\n\n   * \\*\\* Defined by the presence of a known ALS causative gene such as C9orf72 in a family member or a family history suggestive of an inherited ALS\u002FFTD syndrome defined by two family members with a history of ALS and\u002For FTD.\n6. Access to a smartphone, computer or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient)\n\nExclusion Criteria for all participants:\n\n1. Significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression \\\u003C= 90 days of screening, that would interfere with the study procedure, according to Investigator's judgement.\n2. Clinically significant unstable medical condition (other than ALS) (e.g., cardiovascular instability, systemic infection, untreated thyroid dysfunction, malignant and potentially progressive cancer) that would render the participant unlikely to be able to complete 12 months of follow-up, according to Investigator's judgment.\n\nExclusion Criteria for participants undergoing optional Lumbar Puncture\n\n1. Medically unable to undergo lumbar puncture (LP) as determined by the site investigator (i.e., bleeding disorder, a skin infection at or near the LP site, known or suspected intracranial or intraspinal tumor or other cause of increased intracranial pressure).\n2. Allergy to Lidocaine or other local anesthetic agents.\n3. Use of anticoagulant medication or antiplatelet medications (aside from aspirin 81 mg) that cannot be safely withheld prior to lumbar puncture.\n4. Blood dyscrasia, abnormal bleeding diathesis, or the use of dialysis for renal failure.\n5. Current pregnancy based on participant self-report\n6. Clinical judgement of the site investigator that the participant would be unable to undergo multiple lumbar punctures.",true,{"count":270,"type":23},2000,"The ALL ALS Clinical Research Consortium is establishing research to collect a wide range of samples, clinical information and measurements from Amyotrophic Lateral Sclerosis (ALS) symptomatic, ALS gene carriers and control cohorts. This consortium is being funded by the National Institutes of Health\u002FNational Institute of Neurological Disorders and Stroke (NIH\u002FNINDS) and managed by two clinical coordinating centers (CCC) at Barrow Neurological Institute and Massachusetts General Hospital. The clinical sites are distributed across the country, and led by a group of collaborative principal investigators. Once data and samples are collected and harmonized, it will be made available to research community for future research into ALS and related neurological diseases.\n\nASSESS protocol is specific for symptomatic ALS and control participants. This protocol includes both on-site and off-site(remote) participants. The participants will be followed for 24 months (2 years), and will include collection of medical history, clinical outcomes, and blood samples once in 4 months. Additionally, the participants will complete patient reported outcomes and speech recordings once a month. Participants who are coming into clinic may also provide optional Cerebrospinal Fluid (CSF) samples.",[29],[127,29,274,275],"biomarker","observational","2026-06-15",{"date":278,"type":34},"2026-06-17",{"date":280,"type":34},"2024-07-25",{"date":282,"type":23},"2029-07-25",{"name":284,"class":236},"St. Joseph's Hospital and Medical Center, Phoenix",{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":268,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":294,"conditions":295,"keywords":296,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":300,"startDateStruct":301,"completionDateStruct":302,"leadSponsor":303,"locationsCount":42},"100560800","prevent-all-als-study-100560800","NCT06581861","PREVENT ALL ALS Study","PREVENT ALL ALS - Longitudinal Biomarker Study for Participants Who Are Genetically at Risk for Amyotrophic Lateral Sclerosis (ALS)","Inclusion Criteria:\n\n1. Age 18 years or older\n2. Capable of providing informed consent\n3. Willing to follow study procedures\n4. First-degree relative of a known carrier of any ALS causative gene1 (regardless of whether ALS or FTD has actually been symptomatic in the family) OR First-degree relative of an individual with ALS and\u002For FTD in a family with a \"compelling family history\" of ALS\u002FFTD, regardless of whether genetic testing has occurred in symptomatic family members. A \"compelling family history\" is defined as a pedigree with at least 2 close relatives who had ALS or FTD, with at least one of those family members having had ALS.\n5. Access to a smartphone, computer, or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient)\n\nExclusion Criteria:\n\n1. Evidence of neurological signs or symptoms concerning for ALS of FTD, at the discretion of the site investigator which will be communicated to the applicant along with referral for appropriate clinical follow-up.\n2. Significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression \\\u003C= 90 days (about 3 months) of screening, which in the opinion of the Investigator would interfere with the study procedures\n3. Clinically significant, unstable medical condition (e.g., cardiovascular instability, systemic infection, untreated thyroid dysfunction, malignant and potentially progressive cancer) that would render the participant unlikely to be able to complete 12 months of follow-up, according to Investigator's judgment\n\nExclusion Criteria for Participants Undergoing Optional Lumbar Puncture\n\n1. Medically unable to undergo lumbar puncture (LP) as determined by the site investigator (i.e., bleeding disorder, a skin infection at or near the LP site, known or suspected intracranial or intraspinal tumor or other cause of increased intracranial pressure).\n2. Allergy to Lidocaine or other local anesthetic agents.\n3. Use of anticoagulant medication or antiplatelet medications (aside from aspirin 81 mg) that cannot be safely withheld prior to lumbar puncture.\n4. Blood dyscrasia, abnormal bleeding diathesis, or the use of dialysis for renal failure.\n5. Current pregnancy based on participant self-report\n6. Clinical judgement of the site investigator that the participant would be unable to undergo multiple lumbar punctures.\n\nInclusion Criteria for Genetic Testing Results Sub-study\n\n1. Age 18 years of age or older\n2. Capable of providing informed consent\n3. Willing to follow study procedures\n4. Currently enrolled in the PREVENT ALS Study",{"count":293,"type":23},600,"The ALL ALS Clinical Research Consortium is establishing research to collect a wide range of samples, clinical information and measurements from Amyotrophic Lateral Sclerosis (ALS) symptomatic, ALS gene carriers and control cohorts. This consortium is begin funded by the National Institutes of Health\u002FNational Institute of Neurological Disorders and Stroke (NIH\u002FNINDS) and managed by two clinical coordinating centers (CCC) at Barrow Neurological Institute and Massachusetts General Hospital. The clinical sites are distributed across the country, and led by a group of collaborative principal investigators. Once data and samples are collected and harmonized, it will be made available to research community for future research into ALS and related neurological diseases.\n\nPREVENT protocol is specific for asymptomatic participants who are genetically at risk for ALS. The participants will be followed for up to 36 months (3 years), and will include 4 in-person on-site visits once a year and 6 off-site(remote) visits once in 4 months. The study includes collection of medical history, clinical outcomes, and blood samples once in 4 months. Additionally, the participants will complete patient reported outcomes and speech recordings once in 4 months. Participants may also provide optional Cerebrospinal Fluid (CSF) samples.The participants may also opt into a sub-study if they are interested in genetic testing for ALS causative genes. The sub-study will involve a minimum of 3 visits over a course of 2-3 months. This will include a screening\u002Fpre-test genetic counseling visit, a return of genetic results and a post-test counseling visit.",[29],[127,29,297,298,299],"Biomarker","Observational","at-risk",{"date":278,"type":34},{"date":280,"type":34},{"date":282,"type":23},{"name":284,"class":236},{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":24,"phases":314,"briefSummary":315,"conditions":316,"keywords":317,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":327},"100470550","phase-2-dazucorilant-in-patients-with-amyotrophic-lateral-sclerosis-100470550","NCT05407324","Dazucorilant in Patients With Amyotrophic Lateral Sclerosis","A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety and Efficacy of CORT113176 (Dazucorilant) in Patients With Amyotrophic Lateral Sclerosis (DAZALS)","DAZALS","Inclusion Criteria:\n\n* Male and female patients ≥18 years of age with sporadic or familial ALS. In Part 1, patients must have a risk of ALS progression characterized by a European Network for the Cure of ALS (ENCALS) risk profile score ≥ -6 and ≤ -3. In Part 2 patients must have a risk of ALS progression characterized by an Treatment Research Initiative to Cure ALS (TRICALS) risk profile score ≥ -7 and ≤ -3.\n* If taking riluzole, edaravone, and\u002For sodium phenylbutyrate and taurursodiol, must be on a stable dose prior to Screening. Sodium phenylbutyrate and taurursodiol are not permitted for patients enrolled in Part 2 of the study.\n* Part 2 only: Patients with a pathogenic mutation in superoxide dismutase 1 gene (SOD1) must not be receiving treatment with tofersen or eligible for treatment with tofersen if available. Patients who have received prior treatment with tofersen and discontinued due to safety and\u002For efficacy reasons prior to Screening are eligible.\n* Part 2 only: Use of ultra high-dose methylcobalamin for the treatment of ALS is permitted provided the patient has been on a stable dose for ≥11 weeks prior to the Day 1 visit.\n\nExclusion Criteria:\n\n* History of a clinically significant non-ALS neurologic disorder\n* Inability to swallow capsules.\n* Blood platelet count \\\u003C150,000\u002Fmm\\^3.\n* Renal impairment indicated by Estimated Glomerular Filtration Rate (eGFR) ≤30 mL\u002Fmin\u002F1.73 m\\^2. Part 2 only: Patients with a recent history of acute kidney injury should have returned to their baseline renal function (i.e, eGFR prior to acute kidney injury) prior to enrollment.\n* Human immunodeficiency virus (HIV) or current chronic\u002Factive infection with hepatitis C virus or hepatitis B virus. Part 2 only: Known history of HIV or chronic\u002Factive infection with hepatitis C or hepatitis B virus; testing does not need to be performed if infection status is unknown.\n* Women who are pregnant, planning to become pregnant, or are breastfeeding.\n* Use of non-invasive ventilation (NIV) or mechanical ventilation via tracheostomy, or on any form of oxygen supplementation.\n* Cancer that is currently being treated (except adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin, stage I endometrial cancer or carcinoma in situ of the cervix or breast) or a history of cancer with an expected survival \\\u003C 2 years.\n* Current or anticipated need of a diaphragm pacing system (DPS).\n* Previous exposure or treatment with glucocorticoid receptor modulators or antagonists.\n* Taking, or have taken, any systemic, inhaled, or potent dermatologic topical corticosteroids (Class I to III) within a period equivalent to 5 half-lives of the corticosteroid used prior to first dose of study drug. Patients who have stopped glucocorticoid use should have an alternative option if their condition deteriorates during the study.",{"count":313,"type":23},279,[86],"The purpose of this 2-part study is to assess the safety and efficacy of CORT113176 (dazucorilant) in patients with Amyotrophic Lateral Sclerosis (ALS).",[29],[318],"ALS, Amyotrophic Lateral Sclerosis","2026-06-12",{"date":252,"type":34},{"date":322,"type":34},"2022-11-15",{"date":324,"type":23},"2027-11",{"name":326,"class":41},"Corcept Therapeutics",35,{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":334,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":338,"conditions":339,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":72},"100465135","dysphagia-qol-and-attitudes-towards-peg-in-als-patients-100465135","NCT05336760","Dysphagia, QoL and Attitudes Towards PEG in ALS Patients","Dysphagia, Quality of Life and Attitudes Towards Percutaneous Endoscopic Gastrostomy in Patients With Amyotrophic Lateral Sclerosis","ALSDPEG","Inclusion Criteria for patients:\n\n* 18 years of age or older\n* diagnosis of ALS\n* follow-up at University Medical Centre Ljubljana, Division of Neurophysiology, every 3 months\n* be able to visit the study site for in-person procedures every 3 months\n\nInclusion Criteria for relatives:\n\n* at least 18 years of age\n\nExclusion Criteria for patients:\n\n* co-existing illness or disorder that could influence the swallowing function independently of the ALS diagnosis\n* clinically significant cognitive deterioration or dementia at enrollment, as determined by the ALS study neurologist\n\nExclusion criteria for relatives:\n\n* signs of probable cognitive deterioration or dementia at enrollment",{"count":337,"type":23},60,"In Amyotrophic Lateral Sclerosis, dysphagia has a high incidence. With deterioration of swallowing function, percutaneous endoscopic gastrostomy (PEG) tube is recommended to ensure sufficient and safe oral intake. Dysphagia and PEG placement alter quality of life (QoL). However, QoL and attitudes toward PEG remain largely unexplored. The purpose of this study is to monitor the swallowing function in relationship to QoL and attitudes toward PEG tube insertion and feeding.",[29],"2026-06-11",{"date":276,"type":34},{"date":343,"type":34},"2023-01-01",{"date":345,"type":23},"2026-09-30",{"name":347,"class":236},"University Rehabilitation Institute, Republic of Slovenia",{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":354,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":358,"conditions":359,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":363,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":173},"100323309","clinical-procedures-to-support-research-in-als-100323309","NCT03489278","Clinical Procedures to Support Research in ALS","Clinical Procedures to Support Research in ALS (CAPTURE-ALS)","CAPTURE-ALS","Inclusion Criteria:\n\n* Diagnosis of ALS or a related disorder (e.g. primary lateral sclerosis, progressive muscular atrophy).\n* Receiving care at a clinical center that uses Epic as its EHR.\n* Able and willing to provide informed consent (or informed consent obtainable from a designated proxy).\n\nExclusion Criteria:\n\n* Inability to understand English and\u002For Spanish",{"count":357,"type":23},1200,"The purpose of the Clinical Procedures To Support Research (CAPTURE) study is to utilize information collected in the medical record to learn more about a disease called amyotrophic lateral sclerosis (ALS) and related disorders.",[29,360,361,362],"ALS-Frontotemporal Dementia","Primary Lateral Sclerosis","Progressive Muscular Atrophy",{"date":276,"type":34},{"date":365,"type":34},"2018-02-15",{"date":367,"type":23},"2034-06",{"name":369,"class":236},"University of Miami",{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":376,"eligibilityCriteria":377,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":378,"enrollmentInfo":379,"targetDuration":4,"studyType":24,"phases":381,"briefSummary":382,"conditions":383,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":260},"100615242","phase-1-a-study-to-investigate-the-safety-and-pharmacodynamics-of-a-single-intrathecal-injection-it-of-ins1202-in-participants-with-amyotrophic-lateral-sclerosis-als-100615242","NCT07290062","A Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection (IT) of INS1202 in Participants With Amyotrophic Lateral Sclerosis (ALS)","A Phase 1, Multicenter, Open-label, Dose-Finding Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection of INS1202 in Patients With Amyotrophic Lateral Sclerosis","ARMOR","Key Inclusion Criteria: -\n\n* Participant with body mass index (BMI) ≥18 kilograms per square meter (kg\u002Fm\\^2).\n* Participant with symptomatic ALS as diagnosed by Gold Coast diagnostic criteria.\n* Sporadic ALS cohorts: Negative testing for known monogenic mutations associated with familial ALS.\n* SOD1-ALS (Cohorts 2 and 3 only): Confirmed pathogenic SOD1 mutation, with negative testing for other genetic mutations associated with familial ALS.\n* Any polymorphism or mutation in the coding region will require additional review by the Sponsor to determine compatibility with the study intervention.\n* Baseline ALSFRS-R ≥ 24.\n* ALS disease duration ≤ 42 months.\n\nKey Exclusion Criteria: -\n\n* Previous treatment for ALS with cellular or gene therapies.\n* Any investigational medication or treatment (for ALS or other condition).\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.","79 Years",{"count":380,"type":23},23,[85],"The primary objective of this dose-finding study is to evaluate the safety, tolerability and pharmacodynamics of single dose of INS1202 via IT administration in participants ≥ 18 to \\\u003C80 years of age with ALS who carry superoxide dismutase type 1 (SOD1) mutations or harbor no known ALS-related genetic mutation.",[29],"2026-06-10",{"date":319,"type":34},{"date":387,"type":34},"2026-01-09",{"date":389,"type":23},"2030-03-31",{"name":391,"class":41},"Insmed Gene Therapy LLC",{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":399,"targetDuration":4,"studyType":24,"phases":401,"briefSummary":402,"conditions":403,"keywords":404,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":416},"100556601","phase-2-a-study-of-ranolazine-in-als-100556601","NCT06527222","A Study of Ranolazine in ALS","Ranolazine in ALS: Safety, and Effect on Cramps, Function and Quality of Life.","Inclusion Criteria:\n\n* 18 years or older\n* Diagnosed with clinically definite, possible, probably, or lab-supported probable ALS per revised El Escorial criteria\n* Breathing assessment called forced vital capacity (FVC) greater than or equal to 50%.\n* Able to swallow pills at the start of the study and expected to for the length of the study.\n* If on ALS modifying medications must be on a stable dose at least 30 days.\n* Experiencing 4 or more cramps per week during a 2-week screening period.\n\nExclusion Criteria:\n\n* Disease duration \\\u003C 5 years\n* Tracheostomy invasive ventilation, or noninvasive ventilation of more than 12 hours\u002Fday\n* Pregnant or lactating, adults unable to consent, and prisoners\n* Taking ranolazine or investigational drug or has received an investigational drug within 30 days (or 5 half-lives for drugs, whichever is longer) prior to screening\n* Medically uncontrolled comorbidities (heart, liver, kidney disease)\n* Baseline QTc interval prolongation \\>450 ms for men\u002F \\>470 ms for women, history of long QT syndrome, or medications which prolong the QT interval\n* Participation in an experimental drug trial less than 30 days before screening\n* Patients have to be on a stable dosage of any medications used to treat muscle cramps for ≥30 days or have been off these medications ≥30 days prior to randomization.",{"count":400,"type":23},72,[86],"The purpose of this study is to evaluate safety, effect on cramps, function and quality of life of ranolazine versus placebo for the treatment of ALS.",[29],[127,59,405,406],"Lou Gehrig's Disease","Placebo-Controlled","2026-06-04",{"date":409,"type":34},"2026-06-08",{"date":411,"type":34},"2025-04-29",{"date":413,"type":23},"2028-07",{"name":415,"class":236},"Swathy Chandrashekhar, MBBS",6,{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":423,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":425,"targetDuration":4,"studyType":24,"phases":426,"briefSummary":427,"conditions":428,"keywords":431,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":4},"100643698","auto-calibrating-system-for-upper-limb-disability-assessment-neurological-and-occupational-rehabilitation-100643698","NCT07636538","Auto-calibrating System for Upper Limb Disability Assessment, Neurological and Occupational Rehabilitation","Auto-calibrating System for Upper Limb Disability Assessment, Neurological and Occupational Rehabilitation (AS-ULDAR)","ASULDAR","Inclusion Criteria:\n\n* Adult patients aged between 18 and 80 years.\n* Confirmed diagnosis of one of the following neurological conditions: stroke, Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), or Mild Cognitive Impairment (MCI).\n* Presence of upper limb motor impairment defined by QuickDASH scores ranging from 20 to 90.\n* Ability to understand and follow the study protocol instructions.\n\nExclusion Criteria:\n\n* Patients with severe psychiatric disorders or cognitive impairments that interfere with the ability to complete cognitive tests and self-assessment scales.\n* Individuals unable to provide informed consent.\n* Subjects with moderate to severe cognitive impairment, defined by an ECAS score lower than 81.92 (ALS patients) or a MoCA score between 18 and 25.\n* Physical conditions significantly limiting upper limb use (e.g., severe concomitant orthopedic disorders affecting shoulder movement).\n* Current or recent participation (within the previous three months) in other rehabilitation programs or interventions that could influence study outcomes.\n* Unstable health conditions that could make device use unsafe or inappropriate, including unstable medical conditions or severe visual impairments.",{"count":83,"type":23},[109],"This interventional, multicenter, low-intervention clinical trial aims to evaluate the usability, feasibility, safety, and preliminary clinical impact of a robotic rehabilitation system designed for upper limb rehabilitation in adults with neurological disorders, including Parkinson's disease (PD), Amyotrophic Lateral Sclerosis (ALS), post-stroke sequelae, and Mild Cognitive Impairment (MCI).\n\nThe system under study combines a collaborative robot (cobot), inertial sensors, and a graphical user interface capable of supporting reaching exercises, trajectory tracking activities, and cognitive exergames, while also enabling automatic acquisition and visualization of patient performance data.\n\nThe main questions the study aims to answer are:\n\nIs the investigational robotic rehabilitation system usable and feasible in neurological patients undergoing upper limb rehabilitation? Is the use of the device safe for both patients and healthcare operators? Does the addition of robotic-assisted rehabilitation to conventional therapy improve upper limb motor performance, cognitive function, and quality of life compared with conventional rehabilitation alone? Do movement measurements collected by the system correlate with standard clinical assessment scales?\n\nResearchers will compare conventional rehabilitation therapy plus robotic-assisted rehabilitation with conventional rehabilitation therapy alone to evaluate the impact of the device on motor, cognitive, and psychosocial outcomes.\n\nThirty participants will be randomized into two parallel treatment groups. Both groups will receive 12 sessions of conventional rehabilitation therapy lasting 60 minutes each, three times per week. Participants assigned to the experimental group will additionally receive robotic-assisted rehabilitation sessions of up to 30 minutes supervised by rehabilitation staff.\n\nParticipants will undergo:\n\nBaseline collection of demographic and clinical information; Motor, cognitive, and activities of daily living assessments using standardized clinical scales; Conventional rehabilitation therapy sessions; Robotic-assisted upper limb rehabilitation exercises, including task-oriented and trajectory-tracking activities (experimental group only); Monitoring of vital parameters and adverse events during device use; Final evaluation of usability, psychosocial impact, patient satisfaction, motor and cognitive outcomes, and safety.",[116,29,429,430],"PARKINSON DISEASE (Disorder)","Mild Cognitive Impairment (MCI)",[432,433,434,435],"Collaborative Robot","Robotic rehabilitation","Neurological disorders","Graphical User Interface","2026-06-03",{"date":438,"type":34},"2026-06-09",{"date":440,"type":23},"2026-06",{"date":442,"type":23},"2026-10",{"name":444,"class":236},"University of Pavia",{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":452,"enrollmentInfo":453,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":455,"conditions":456,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":457,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":72},"100369962","biomarkers-in-different-types-of-amyotrophic-lateral-sclerosis-als-patients-being-treated-with-edaravone-100369962","NCT04097158","Biomarkers in Different Types of Amyotrophic Lateral Sclerosis (ALS) Patients Being Treated With Edaravone","Oxidative Markers and Efficacy in Amyotrophic Lateral Sclerosis (ALS) Phenotypes Treated With Edaravone","Inclusion Criteria:\n\n1. Either possible, probable, or definite ALS, predominantly lower motor neuron disease, predominantly upper motor neuron disease, or bulbar\n2. With or without cognitive involvement\n3. Willing to participate\n4. On no experimental treatment\n5. Ages 18 - 85\n6. No prior exposure to Edaravone (Radicava)\n7. On a stable dose of Riluzole for 30 days or off Riluzole\n8. Male or female\n9. Females of childbearing age must use contraception\n\nExclusion Criteria:\n\n1. Unstable medical illness\n2. Abnormal liver function (\\>2x ULN)\n3. Unlikely to survive for 26 weeks","85 Years",{"count":454,"type":23},160,"This study is being conducted to help the investigators better understand how the new FDA approved medication Edaravone (also known as Radicava) works in subsets of patients with ALS. The investigators are also trying to understand if there are specific ALS patients, with different presentations of ALS, who might benefit most from this medication. Also, the investigators are following specific biomarkers to determine the optimal treatment duration in patients with different forms of ALS\n\nThere is no study medication being offered in this trial. Edaravone is prescribed as part of regular care. In this trial we are collecting blood, urine, and spinal fluid samples in ALS patients who are taking Edaravone and ALS patients who are not taking Edaravone to measure certain markers that could indicate why the drug may be working in a specific type of ALS.",[29],{"date":458,"type":34},"2026-06-05",{"date":460,"type":34},"2019-10-08",{"date":462,"type":23},"2027-04",{"name":464,"class":236},"Loma Linda University",{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":472,"targetDuration":4,"studyType":24,"phases":474,"briefSummary":475,"conditions":476,"keywords":477,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":486,"locationsCount":488},"100385359","phase-2-healey-als-platform-trial---master-protocol-100385359","NCT04297683","HEALEY ALS Platform Trial - Master Protocol","HEALEY ALS Platform Trial","Inclusion Criteria:\n\n1. Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS defined by revised El Escorial criteria.\n2. Age 18 years or older.\n3. Capable of providing informed consent and complying with study procedures, in the SI's opinion.\n4. Time since onset of weakness due to ALS ≤ 24 months at the time of the Master Protocol Screening Visit.\n5. Vital Capacity ≥ 50% of predicted capacity at the time of the Master Protocol Screening Visit measured by Slow Vital Capacity (SVC), or, if required due to pandemic-related restrictions, Forced Vital Capacity (FVC) measured in person.\n6. Participants must either not take riluzole or be on a stable dose of riluzole for ≥ 30 days prior to the Master Protocol Screening Visit.\n7. Participants must either not take edaravone or have completed at least one cycle (typically 14 days) of edaravone prior to the Master Protocol Screening Visit.\n8. Participants must have the ability to swallow pills and liquids at the time of the Master Protocol Screening Visit and, in the SI's opinion, have the ability to swallow for the duration of the study.\n9. Geographically accessible to the site.\n\nExclusion Criteria:\n\n1. Clinically significant unstable medical condition (other than ALS) that would pose a risk to the participant, according to SI's judgment (e.g., cardiovascular instability, systemic infection), or clinically significant laboratory abnormality or EKG changes. Clinically significant abnormal liver or kidney function is exclusionary. The following values \\[alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 times the upper limit of normal (ULN) or estimated Glomerular Filtration Rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73m2\\] are exclusionary regardless of clinical symptoms.\n2. Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide informed consent, in the SI's opinion.\n3. Active cancer or history of cancer, except for the following: basal cell carcinoma or successfully treated squamous cell carcinoma of the skin, cervical carcinoma in situ, prostatic carcinoma in situ, or other malignancies curatively treated and with no evidence of disease recurrence for at least 3 years.\n4. Use of investigational treatments for ALS (off-label use or active participation in a clinical trial) within 5 half-lives (if known) or 30 days (whichever is longer) prior to the Master Protocol Screening Visit.\n5. Exposure at any time to any gene therapies under investigation for the treatment of ALS (off-label use or investigational).\n6. If female, breastfeeding, known to be pregnant, planning to become pregnant during the study, or of child-bearing potential and unwilling to use effective contraception, for the duration of the trial and for 3 months, or as specified in each RSA, after discontinuing study treatment.\n7. If male of reproductive capacity, unwilling to use effective contraception for the duration of the trial and for 3 months, or as specified in each RSA, after discontinuing study treatment.\n8. Anything that would place the participant at increased risk or preclude the participant's full compliance with or completion of the study, in the SI's opinion.\n9. If a participant is being re-screened, the disqualifying condition has not been resolved, or the mandatory wash-out duration has not occurred.",{"count":473,"type":23},1500,[86,26],"The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.",[29],[127,406,478,479,405],"Double-Blind","Master Protocol","2026-06-02",{"date":407,"type":34},{"date":483,"type":34},"2020-06-14",{"date":485,"type":23},"2028-08",{"name":487,"class":236},"Merit E. Cudkowicz, MD",81,{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":495,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":497,"targetDuration":4,"studyType":24,"phases":498,"briefSummary":499,"conditions":500,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":516},"100494899","feasibility-of-the-braingate2-neural-interface-system-in-persons-with-tetraplegia-100494899","NCT05724173","Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia","Single Neuron Population Dynamics in Human Speech Motor Cortex for a Speech Prosthesis","BG-Speech-01","Inclusion Criteria:\n\n* Between 18 and 80 years of age.\n* Participants must have a diagnosis of amyotrophic lateral sclerosis (ALS) as verified by a clinical expert in neurologic diseases.\n* Participants with a diagnosis of ALS with anarthria, or severe dysarthria with decline in the preceding four months.\n* Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment.\n\nExclusion Criteria:\n\n* Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses\n* Chronic oral or intravenous steroids or immunosuppressive therapy\n* Other serious disease or disorder that could seriously affect ability to participate in the study\n\n(There are additional exclusion criteria)",{"count":150,"type":23},[109],"The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.",[501,502,503,504,29,505,506,507],"Anarthria","Dysarthria","Tetraplegia","Spinal Cord Injuries","Brain Stem Infarctions","Locked in Syndrome","Muscular Dystrophies","2026-05-29",{"date":480,"type":34},{"date":511,"type":34},"2023-10-18",{"date":513,"type":23},"2027-07-31",{"name":515,"class":236},"Leigh R. Hochberg, MD, PhD.",2,{"id":518,"slug":519,"hasResults":12,"nctId":520,"briefTitle":521,"officialTitle":521,"acronym":522,"eligibilityCriteria":523,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":524,"targetDuration":4,"studyType":24,"phases":526,"briefSummary":499,"conditions":527,"keywords":529,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":416},"100126292","braingate2-feasibility-study-of-an-intracortical-neural-interface-system-for-persons-with-tetraplegia-100126292","NCT00912041","BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia","BrainGate2","Inclusion Criteria:\n\n* Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders\n* Complete or incomplete tetraplegia (quadriplegia)\n* Must live within a three-hour drive of the Study site\n* (There are additional inclusion criteria)\n\nExclusion Criteria:\n\n* Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses\n* Chronic oral or intravenous steroids or immunosuppressive therapy\n* Other serious disease or disorder that could seriously affect ability to participate in the study\n* (There are additional exclusion criteria)",{"count":525,"type":23},27,[109],[503,504,29,505,506,528],"Muscular Dystrophy",[530,531,532,533,534,535],"Brain computer interface","Assistive device","Environmental control","Communication device","quadriplegia","tetraplegia","2026-05-28",{"date":538,"type":34},"2026-06-01",{"date":540,"type":4},"2009-05",{"date":542,"type":23},"2038-12",{"name":515,"class":236},{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":24,"phases":554,"briefSummary":555,"conditions":556,"keywords":560,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":572,"completionDateStruct":573,"leadSponsor":575,"locationsCount":237},"100639065","evaluation-of-the-impact-of-virtual-park-on-training-motivation-in-adult-patients-100639065","NCT07616050","Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients","Evaluation of the Impact of a Rehabilitation Intervention Based on Cycling With Virtual Park on Training Motivation in Adult Patients","VP_Adults","Inclusion Criteria:\n\n* Informed consent to the study\n* subjects \\> 18 years and \\\u003C85 years\n* diagnosis of MCI according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders VTh Edition (DSM V TR American Psychological Association 2013)\n* detection of ischemic stroke within 6 months preceding the study, frail elderly subjects (Gobbens RJ et al. 2010)\n* subjects affected by idiopathic Parkinson's disease according to the MDS-PD criteria (Postuma et al., 2015)\n* subjects affected by possible, probable and definite ALS according to the revised El Escorial criteria (Brooks Br, et al. 2000)\n* subjects affected by MS according to the McDonald criteria (2017) with disability measured with the EDSS (Expanded Disability Status Scale) \\\u003C= 8\n* patients with spinal cord injury of different etiology with incomplete spinal cord injury, AIS (ASIA impairment scale) grade C and D, MMSE \\>18\n* subjects naïve to the use of the RV\n* no therapeutic changes or rehabilitation interventions in the month prior to inclusion in the study\n* no ongoing behavioral disorders.\n\nExclusion Criteria:\n\n* Other concomitant neurological pathologies in addition to the one under study\n* presence of visual disturbances that do not allow access to the experimental virtual reality protocol\n* presence of impaired cardiorespiratory function or other organic instabilities that contraindicate ergometer training\n* severe osteoporosis",{"count":553,"type":23},70,[109],"The purpose of this clinical study is to evaluate the feasibility, usability, and motivational impact of VirtualPark, a virtual reality-based dual-task rehabilitation system, in adults with neurological and age-related conditions.\n\nVirtualPark is a virtual reality application designed to deliver cognitive exercises during cycling training using a commercially available ergometer (THERA-Trainer Tigo). The system integrates physical and cognitive tasks in simulated real-life environments.\n\nThe intervention integrates motor and cognitive training tasks targeting domains such as attention, inhibition, working memory, and navigation.\n\nThis is a prospective, multicenter, randomized, cross-over pilot study. It will compare cycling training performed with and without virtual reality. Participants will complete both intervention conditions over a 4-week period separated by a wash-out phase with standard rehabilitation activities. The order of conditions will be randomized.\n\nThe study will assess motivation during rehabilitation training, usability and user experience of the system, as well as exploratory effects on cognitive and motor performance, functional abilities, perceived exertion, and safety.\n\nThe study will enroll adult participants (≥18 years) with conditions such as stroke, Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, mild cognitive impairment, spinal cord injury, and frail older adults.",[557,558,29,430,138,559],"Post-stroke","Parkinson Disease","Frailty at Older Adults",[561,562,29,563,138,564,565,566,567,568,569],"post-stroke","parkinson disease","Mild Cognitive Impairment","spinal cord injury","rehabilitation","dual-task","virtual reality","intrinsic motivation","frail elderly patients with multiple comorbidities","2026-05-25",{"date":508,"type":34},{"date":440,"type":23},{"date":574,"type":23},"2027-01",{"name":576,"class":236},"Marta Mondellini",{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":583,"eligibilityCriteria":584,"healthyVolunteers":12,"sex":18,"minAge":585,"maxAge":586,"enrollmentInfo":587,"targetDuration":588,"studyType":52,"phases":4,"briefSummary":589,"conditions":590,"keywords":591,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":595,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":604},"100448433","genetic-study-of-amyotrophic-lateral-sclerosis-in-norway-100448433","NCT05119387","Genetic Study of Amyotrophic Lateral Sclerosis in Norway","Genetisk Studie av Amyotrofisk Lateral Sklerose (ALS)","GAIN","Inclusion Criteria:\n\n* Probable or definite ALS\n* Eligible to consent\n\nExclusion Criteria:\n\n\\- not competent to give consent","16 Years","100 Years",{"count":357,"type":23},"5 Years","The purpose of this study is to explore the genetic causes relevant for ALS development in Norway.",[29],[224,29,592,593],"Neurology","Clinical genetics","2026-05-18",{"date":596,"type":34},"2026-05-19",{"date":598,"type":34},"2019-08-01",{"date":600,"type":23},"2035-12-31",{"name":602,"class":603},"Sykehuset Telemark","OTHER_GOV",17,{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":610,"acronym":4,"eligibilityCriteria":611,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":612,"targetDuration":4,"studyType":24,"phases":614,"briefSummary":615,"conditions":616,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":617,"lastUpdatePostDateStruct":618,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":623,"locationsCount":4},"100628907","phase-2-research-of-traditional-chinese-medicine-oral-preparation-of-c-cicadae-in-the-treatment-of-als-patients-with-elevated-plasma-sphingolipids-100628907","NCT07467746","Research of Traditional Chinese Medicine Oral Preparation of C. Cicadae in the Treatment of ALS Patients With Elevated Plasma Sphingolipids","Single-center Study of Traditional Chinese Medicine Oral Preparation of C. Cicadae in the Treatment of ALS Patients With Elevated Plasma Sphingolipids","Inclusion Criteria:\n\n* Patients with ALS diagnosed according to the revised El Escorial criteria.\n* Significantly elevated plasma levels of key SL molecules (e.g., Cer(d18:0\u002F24:0), Cer(d18:1\u002F22:0), and other relevant molecules), meeting the predefined cut-off values for metabolic stratification.\n* Time from disease onset to enrollment ≤24 months\n* For participants receiving riluzole and\u002For edaravone, the dose must have been stable for at least 30 days prior to enrollment.\n* Male or non-pregnant, non-lactating female patients, aged \\> 18 and ≤ 80 years old.\n* Voluntarily participate in clinical trials, sign informed consent, and be able to understand and abide by research procedures.\n\nExclusion Criteria:\n\n* Presence of peripheral neuropathy or motor neuron injury attributable to other clearly defined etiologies and sufficient to interfere with disease classification in this study, including but not limited to vitamin deficiency, toxic neuropathy, drug- or chemotherapy-related neuropathy, alcoholic neuropathy, paraneoplastic syndrome, autoimmune neuropathy, and infection-related neuropathy;\n* Severe hepatic or renal dysfunction that may affect the safety evaluation of the investigational product or the interpretation of metabolomics results;\n* Severe cardiopulmonary dysfunction, active infection, active malignancy, or other major systemic diseases that, in the opinion of the investigator, may significantly affect prognosis assessment or completion of follow-up;\n* Women who are pregnant or breastfeeding, or who plan to become pregnant during the study period;\n* Participation in another interventional clinical trial within 30 days prior to enrollment, or being within the washout period of another investigational product;\n* Inability to comply with clinical assessments, sample collection, or follow-up procedures;\n* Persistent high dependence on noninvasive ventilation (\\>16 hours\u002Fday), or advanced respiratory failure as judged by the investigator, such that the participant is unable to complete oral intervention and efficacy evaluation;\n* Severe dysphagia, gastrointestinal dysfunction, or other conditions rendering the participant unable to tolerate oral administration;\n* Known allergy to C. cicadae preparations, fungal products, or any of their excipients;\n* Concomitant diseases or conditions that may substantially affect motor function assessment and thereby interfere with evaluation of the primary endpoint;\n* Any other condition that, in the opinion of the investigator, makes the participant unsuitable for study participation.",{"count":613,"type":23},84,[86],"Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease characterized by the degeneration of motor neurons, leading to progressive muscle weakness and functional decline. This study is designed as a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of an oral preparation of C. cicadae in patients with sporadic ALS and elevated plasma sphingolipid (SL) levels. Efficacy will be assessed primarily by changes in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) score and plasma SL levels.Participants who meet the eligibility criteria and provide written informed consent will be randomly assigned in a 1:1 ratio to either the C. cicadae treatment group or the placebo group. The treatment group will receive oral C. cicadae at a dose of 0.1 g\u002Fkg\u002Fday (dry weight), administered in three divided doses per day. The placebo group will receive a matched placebo with a similar appearance and odor, administered according to the same schedule. A total of approximately 84 participants will be enrolled. The intervention period will be 6 months, and participants will be followed for a total of 9 months.",[29],"2026-05-17",{"date":619,"type":34},"2026-05-20",{"date":621,"type":23},"2026-04",{"date":462,"type":23},{"name":624,"class":236},"The Third Xiangya Hospital of Central South University",{"id":626,"slug":627,"hasResults":12,"nctId":628,"briefTitle":629,"officialTitle":630,"acronym":4,"eligibilityCriteria":631,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":632,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":634,"conditions":635,"keywords":636,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":650,"locationsCount":150},"100572572","multicenter-als-imaging-study-100572572","NCT06735014","Multicenter ALS Imaging Study","Multicenter Longitudinal Imaging in ALS for Disease Biomarker Development","For participants with ALS:\n\n* \\\u003C 36 months since onset of symptoms\n* Definite, probable, lab supported-probable or possible ALS by El Escorial criteria OR definite, probable or possible ALS per Awaji-Shima Criteria\n* Forced vital capacity within the last 90 days ≥ 60% of the predicted value\n* Able to consent for themselves\n* Able to read and speak English\n* Clear of any contraindications for MRI\n\nExclusion Criteria:\n\n* Individuals will be excluded if they have any condition that makes MRI unsafe or if they are unable to comply with instructions.\n* All participants will undergo a neurologic examination at enrollment. Control participants with clinically significant abnormal findings on neurological examination will be excluded from the study.",{"count":633,"type":23},90,"This is a multi-site study of ALS participants and healthy controls who will undergo brain and cervical spine MRIs and NfL blood testing at up-to 4 time points over the course of a year. The primary goal is to identify objective biomarkers of disease progression that are biologically relevant, linearly progressive, and sensitive to change.",[29,127],[637,638,639,640,641,642],"Magnetic Resonance Imaging","MRI","ALSFRS-R","ECAS","plasma neurofilament light","NfL","2026-05-07",{"date":645,"type":34},"2026-05-12",{"date":647,"type":34},"2024-09-15",{"date":649,"type":23},"2028-08-31",{"name":651,"class":236},"University of Minnesota"]