[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"muscular-disorders-atrophic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:muscular-disorders-atrophic":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,69,102,114,150],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":42,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100053565","phase-3-a-phase-3-study-to-evaluate-the-safety-and-efficacy-of-aoc-1044-also-referred-to-as-delpacibart-zotadirsen-in-participants-with-dmd-with-gene-mutations-amenable-to-exon-44-skipping-100053565",false,"NCT07587242","A Phase 3 Study to Evaluate the Safety and Efficacy of AOC 1044 (Also Referred to as Delpacibart Zotadirsen) in Participants With DMD With Gene Mutations Amenable to Exon 44 Skipping","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Global Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Intravenous AOC 1044 (Delpacibart Zotadirsen) for the Treatment of DMD With Gene Mutations Amenable to Exon 44 Skipping","SAFARI44","Key Inclusion Criteria:\n\n* Ambulatory males with clinical and genetic diagnosis of DMD\n* Acceptable genetic test confirming dystrophin gene mutation amenable to exon 44 skipping\n* 7 to 16 years of age at time of consent\n* TTR and NSAA assessment completed within the protocol specified parameters at Screening\n* On a stable regimen of corticosteroids (including Vamolorone) for at least 6 months prior to Day 1. Steroid regimen must be anticipated to remain stable.\n\nKey Exclusion Criteria:\n\n* Previous treatment cell or gene therapy.\n* Treatment with another oligonucleotide within 6 months of informed consent (not including COVID-19 RNA vaccines).\n* Lab values outside of the protocol specified range at Screening\n* If on any of the following treatments (growth hormone, testosterone or givinostat), participants must be on a stable regimen and must plan to maintain it for the duration of the study. Participants will be excluded if regimen stability prior to informed consent is as follows:\n* Less than 1 month, for growth hormone and\u002For testosterone\n* Less than 6 months for givinostat","MALE","7 Years","16 Years",{"count":21,"type":22},70,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous AOC 1044 for the treatment of Duchenne Muscular Dystrophy (DMD) with Gene Mutations Amenable to Exon 44 Skipping",[28,29,30,31,32,33,34,35,36,37,38,39,40,41],"Muscular Dystrophies","Muscular Dystrophies (Duchenne, Becker, Myotonic Dystrophy)","Muscular Disorders, Atrophic","Muscular Disease","Musculoskeletal Diseases","Neuromuscular Diseases (NMD)","Nervous System Diseases","Genetic Diseases","X-Linked","Hereditary","Neonatal Disease","Duchene Muscular Dystrophy","Congenital","DMD",[43,44,45,46,47,48,49,50,15,51,52,53,54,55,56,41],"AOC","AOC 1044","AOC 1044-CS3","AOC 1044-CS1","AOC 1044-CS2","EXPLORE44","EXPLORE44-OLE","SAFARI","SAFARI 44","Avidity","Avidity Biosciences","Exon Skipping Therapy","Avidity Biosciences Inc., A Novartis Company","del-zota","NOT_YET_RECRUITING","2026-07-10",{"date":60,"type":61},"2026-07-13","ACTUAL",{"date":63,"type":22},"2026-06",{"date":65,"type":22},"2030-07",{"name":67,"class":68},"Avidity Biosciences, Inc.","INDUSTRY",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":76,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":78,"conditions":79,"keywords":85,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":100,"locationsCount":101},"100612219","managed-access-program-for-del-zota-in-participants-with-dmd-mutations-amenable-to-exon-44-skipping-100612219","NCT07250737","Managed Access Program for Del-zota in Participants With DMD Mutations Amenable to Exon 44 Skipping","Managed Access to Investigational Use of AOC 1044 in Participants With DMD Mutations Amenable to Exon 44 Skipping","Key Inclusion Criteria\n\nRollover Participants\n\n* Completed Study EXPLORE44-OLE Treatment Period (through W102)\n* No significant tolerability issues with AOC 1044\n\nNew (Non-Rollover) Participants\n\n* Permanently residing in the US and have a US primary health care provider\n* Documented dystrophin gene mutation that is amenable to exon 44 skipping\n* Age 2 or older at the time of consent\n* If previously treated with gene therapy for DMD, treatment and associated immunosuppressive regimen was more than 12 months before consent and in the opinion of the prescriber, participant has had an unsatisfactory treatment response\n\nKey Exclusion Criteria\n\nRollover Participants\n\n• Prescence of any new condition or worsening of existing condition that could affect participant's safety or ability to comply with the program requirements\n\nNew (Non-Rollover) Participants\n\n* Recently treated with or on a clinical study for another investigation drug\n* Serious respiratory or cardiac dysfunction, or nearing end of life\n* Screening laboratory parameters do not meet protocol requirements\n* History of multiple drug allergies or to any component of AOC 1044\n* Participants who discontinued early from the treatment period of EXPLORE44 or EXPLORE44-OLE","2 Years","EXPANDED_ACCESS","The purpose of this Managed Access Program is to allow access to delpacibart zotadirsen (AOC 1044) for eligible patients diagnosed with DMD mutations amenable to exon 44 skipping. The patient's Administering Physician should follow the suggested treatment guidelines and comply with all local health authority regulations.",[30,80,32,81,34,82,83,28,84],"Muscular Diseases","Neuromuscular Diseases","Genetic Diseases, Inborn","Genetic Diseases, X-Linked","Muscular Dystrophy, Duchenne",[52,53,44,46,47,48,49,86,87,41,88,89,90,91,92,93,94,95],"Del-zota","delpacibart zotadirsen","exon skipping therapy","dystrophin","managed access","expanded access","pre-approval access","compassionate use","MAP","EAP","AVAILABLE","2026-06-26",{"date":99,"type":61},"2026-06-29",{"name":67,"class":68},14,{"id":103,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":104,"targetDuration":4,"studyType":23,"phases":105,"briefSummary":26,"conditions":106,"keywords":107,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":112,"leadSponsor":113,"locationsCount":4},"100638788",{"count":21,"type":22},[25],[28,29,30,31,32,33,34,35,36,37,38,39,40,41],[43,44,45,46,47,48,49,50,15,51,52,53,54,55,56,41],"2026-05-08",{"date":110,"type":61},"2026-05-14",{"date":63,"type":22},{"date":65,"type":22},{"name":67,"class":68},{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":121,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":23,"phases":125,"briefSummary":127,"conditions":128,"keywords":136,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":144,"leadSponsor":146,"locationsCount":149},"100633072","interfacing-with-neurotechnology-to-expand-neural-throughput-intent-100633072","NCT07521930","Interfacing With NeuroTechnology to Expand Neural Throughput (INTENT)","INTENT","Inclusion Criteria:\n\n* Complete or incomplete tetraplegia (quadriplegia), tetraparesis (quadriparesis), severe ataxia, or disabling motor impairments in both upper limbs, based on neurological exam. In addition, these motor impairments may be combined with severe motor-related speech impairment (dysarthria or anarthria), as in Locked In Syndrome (LIS) and amyotrophic lateral sclerosis (ALS), including the bulbar variant of ALS.\n* Clinical diagnosis must be established for the etiology of motor impairments, including brainstem stroke\\*, traumatic spinal cord injury (SCI), or progressive and irreversible neuromuscular disease, including muscular dystrophy and motor neuron disease, including amyotrophic lateral sclerosis (ALS). \\*Brain stem stroke is defined as an acute onset of neurological deficit with clinical features of brain stem or cerebellar dysfunction lasting more than 24 hours together with computed tomography (CT) or magnetic resonance imaging (MRI) evidence of ischemic infarction or parenchymal hemorrhage.\n* Candidates with traumatic spinal cord injury must have a complete or incomplete tetraplegia or tetraparesis (ASIA Impairment Scale A, B, C) with an injury level of C6 or higher.\n* Candidates with tetraplegia or tetraparesis from traumatic SCI and other non-progressive neurological disorders must have an upper extremity motor score (UEMS, ISNCSCI) of 7 or less in each of the upper extremities. Candidate must also have less than antigravity strength (\\\u003C 3) throughout the lower limbs.\n* Candidates with progressive conditions with shortened life expectancy, such as ALS, must have less than antigravity strength (\\\u003C3) throughout the upper limbs.\n* Persistence of motor impairments at least 12 months prior to enrollment if due to a non-progressive neurological cause such as stroke or spinal cord injury\n* Meeting surgical safety criteria, including surgical clearance by the participant's primary healthcare provider, study physicians, and any necessary consultants\n* Ability to communicate reliably, such as through speech or eye movement\n* Stable psychosocial support system with caregiver capable of monitoring participant throughout the study\n* Ability and willingness to travel to study location up to five days per week for the duration of the study\n* Ability to understand and comply with study session instructions\n* Corrected visual acuity sufficient for use of computer monitor\n\nExclusion Criteria:\n\n* Psychiatric conditions or cognitive impairments that would interfere with obtaining informed consent or fully participating in study activities.\n* Individuals with active implanted devices, including devices that are incompatible with magnetic resonance imaging (MRI).\n* Contraindications to MRI or anticipated need for an MRI during the study period\n* Medical conditions contraindicating device implantation surgery (for example significant pulmonary, cardiovascular, metabolic, or renal impairments making the surgical procedure unsafe)\n* Chronic anti-coagulation and medical contraindication to temporary suspension for surgery\n* Medical conditions contraindicating chronic device implantation (e.g. osteomyelitis, chronic infection, poorly controlled diabetes, cancer, severe autoimmune disorder, epilepsy, poor wound healing)\n* Participants with dental caries and a significant risk of dental or periodontal infection\n* Chronic oral or intravenous use of steroids or immunosuppressive therapy\n* Active cancer within the past year or ongoing chemotherapy\n* Uncontrolled autonomic dysreflexia within the past 3 months\n* Hydrocephalus with or without an implanted ventricular shunt\n* Other chronic, unstable medical conditions that could interfere with subject participation.\n* Persistent suicidal ideation within the past 12 months.\n* History of substance use disorder within the past year\n* Pregnancy (confirmation through blood test)\n* Nursing an infant, planning to become pregnant, or not using adequate birth control","ALL","18 Years","80 Years",{"count":5,"type":22},[126],"NA","The goal of this clinical trial is to evaluate the safety and preliminary efficacy of an implantable device that records and stimulates different areas of the brain to allow adults affected by disabling paralysis (see Eligibility for more details) to control and receive feedback from assistive devices.",[129,130,30,131,132,28,133,134,135],"Tetraplegia\u002FTetraparesis","Amyotrophic Lateral Sclerosis (ALS)","Brain Stem Stroke","Spinal Cord Injuries (SCI)","Muscular Atrophy, Progressive","Pontine Hemorrhage","Pontine Infarction",[137,138],"Assistive device","Brain Computer Interface","RECRUITING","2026-04-02",{"date":142,"type":61},"2026-04-13",{"date":63,"type":22},{"date":145,"type":22},"2028-12",{"name":147,"class":148},"Johns Hopkins University","OTHER",1,{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":158,"sex":121,"minAge":159,"maxAge":160,"enrollmentInfo":161,"targetDuration":4,"studyType":23,"phases":163,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":184},"100583058","dietary-strategy-to-tackle-cognitive-and-locomotor-abilities-in-early-elderly-subjects-100583058","NCT06871384","Dietary Strategy to Tackle Cognitive and Locomotor Abilities in Early Elderly Subjects","Polyphenols From Nonalcoholic Red Wine and Healthy Aging: an Opportunity to Understand Diet Modulation of the Aging Process From a Multidimensional Perspective","WinAging","Inclusion Criteria:\n\n1\\. Men or women between 60-74 years old; Sensory tolerance to red wine; Written informed consent provided before the initial screening visit.\n\nExclusion Criteria:\n\n1. Men or women \\>75 years old,\n2. Hypoglucaemiant treatment or type 1 and type 2 diabetes mellitus diagnosed\n3. Anaemia (hemoglobin ≤13 g\u002FdL in men and ≤12 g\u002FdL in women)\n4. Subjects diagnosed of intestinal disorders such as chron disease, colitis ulcerous, and irritable bowel syndrome\n5. To present a clinical active chronic disease\n6. To present severe sarcopenia\n7. To present cognitive impairment (MMSE ≤ 24 or clinical diagnosis of mild cognitive impairment or dementia)\n8. Dietary allergies to: Mediterranean foods (eg, nuts), sulphytes or nitrates\n9. Use of antioxidants supplements\n10. Regular consumers of red wine who do not agree to change the consumption of red wine with alcohol to nonalcholized wine during the intervention\n11. Chronic alcoholism\n12. Current or past participation in a clinical trial or consumption of a research product in the 30 days prior to inclusion in the study\n13. Failure to follow the study guidelines. For participation in the muscle biopsy, additional exclusion criteria included: Use of prescription anti-platelet medication; Prescription anticoagulant use (or antiaggregant, or acenocoumarol; Conditions which would reduce healing; or known allergy to lidocaine.",true,"60 Years","74 Years",{"count":162,"type":22},72,[126],"Polyphenols, precisely resveratrol, with red wine as the most substantial source, was associated with improvements in cognitive function. Also, the loss of muscle mass and strength in elderly, that significantly increases dependency of these people, it could be attributed to alterations in gut microbiota through the \"gut-muscle axis\" and this underline the urgent need to efficiently find out any intervention or preventive approach via modulation of gut microbiota to improve muscle function in elderly. In this context, red wine polyphenols exert their effects through interaction with gut microbiota following the well-known two-way interaction between polyphenols and gut microbiota by promoting the proliferation of beneficial bacteria and increasing their abundance. Similarly, aging cognitive decline can be modulate by microbiota, notably through \"gut-brain axis\". Additionally, dietary polyphenols can delay inflammation or\u002Fand oxidation on the onset of age-related cognitive decline or muscular oxidation or cardiovascular factors risk factors, all of them relevant factors for the onset of physical frailty and dependence in elderly.\n\nMoreover, wine is a singular alcoholic beverage with a high content of phenolic compounds of a very diverse nature on which numerous protective effects on health have been described. In fact, wine, in addition to alcohol, contains a complex mixture of polyphenols, including anthocyanins and non-coloured phenols as proanthocyanidins, flavonols, hydroxycinnamic and hydroxybenzoic acids, stilbenes and lignans. Thus, the bioprotective effects of wine polyphenols could be the consequence of the synergistic effect of this complex mixture of polyphenols from the grape and the winemaking process. That is why it is essential to clarify whether consumption of polyphenols from red wine provided by a nonalcohol red wine within a healthy diet can produce beneficial effects on health, differentiating this pattern from a general consumption of alcohol generally associated with negative effects. Based on the ethical limitations to carry out diet intervention studies with wine in humans, this project proposes the use of a nonalcoholic wine as vehicle of the complex mixture of red wine polyphenols.\n\nThe hypothesis of our research is that regular consumption of red wine polyphenols, 150 mg\u002Fday, delivered through a nonalcoholic red wine, in the context of a Mediterranean diet (MD pattern), could promote protective mechanisms for a healthy aging, especially through its beneficial effects on cognitive and locomotor abilities and mediated by the modulation of the intestinal microbiota (composition, function and associated metabolome). The main objective of the WinAging project is to add knowledge concerning the diet modulation of molecular mechanisms of the aging process through multi-omic approaches based on the potential health effects of a dietary strategy by a sustained MD supplementation with nonalcoholic red wine rich in polyphenols to tackle cognitive and locomotor abilities in early elderly home-dwelling subjects.\n\nThe specific objectives:\n\n* Objective 1. To develop a nonalcoholic red wine with high phenolic content and sensorial acceptability.\n* Objective 2. To evaluate the chronic effects of the intake of wine polyphenols (average dose 150 mg\u002Fday) delivered through a nonalcoholic red wine in the context of a MD in early elderly home-dwelling subjects, and applying participatory research to increase adherence of subjects in the clinical intervention study.\n\n  * Objective 2.1. To identify selective biological phenolic metabolites in human urine samples to be used as biomarkers of nonalcoholic red wine intake.\n  * Objective 2.2. To assess the effects of the diet supplementation with red wine polyphenols on the improvement of cognitive ability.\n  * Objective 2.3. To assess the effects of the diet supplementation with red wine polyphenols on the improvement of locomotor ability\n  * Objective 2.4. To evaluate the effect of the diet supplementation with red wine polyphenols on the improvement of cardiovascular disease (CVD) risk factors.\n* Objective 3. To unravel the underlying mechanisms involved in the potential beneficial effects of red wine polyphenols on aging.\n\n  * Objective 3.1. To evaluate the influence on microbiota composition, function and microbial catabolites.\n  * Objective 3.2. To evaluate the impact on inflammation and gut health.\n  * Objective 3.3. To evaluate the impact on metabolic pathways related with aging\n  * Objective 3.4. To analyze the impact on age-related epigenetic modifications\n  * Objective 3.5. To deeply characterize the underlying muscle signalling pathways affected using an animal model of aging.\n* Objective 4. To apply integrative computational analyses for the identification of variables (clinical or gut-related) more determinant for a successful prevention of locomotor and cognitive abilities associated with wine polyphenols.",[166,30],"Cognitive Disorders",[168,169,170,171,172,173,174],"cognitive impairment","locomotor impairment","sarcopenia","aging","mediterrnean diet","non-alcoholic wine","polyphenols","2026-03-03",{"date":177,"type":61},"2026-03-05",{"date":179,"type":61},"2025-03-26",{"date":181,"type":22},"2027-04",{"name":183,"class":148},"University Rovira i Virgili",3]