[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Prilenia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":67},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"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":21,"type":22},500,"ESTIMATED","INTERVENTIONAL",[25],"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",[28],"Amyotrophic Lateral Sclerosis","RECRUITING","2026-07-01",{"date":32,"type":33},"2026-07-02","ACTUAL",{"date":35,"type":33},"2026-02-01",{"date":37,"type":22},"2029-03",{"name":39,"class":40},"Prilenia","INDUSTRY",32,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100637382","phase-3-pridopidine-phase-3-study-in-huntingtons-disease-100637382","NCT07609108","Pridopidine Phase 3 Study in Huntington's Disease","A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants With Huntington's Disease (HD)","PRECISE-HD","Inclusion Criteria:\n\n* Adult-onset HD (onset of signs and symptoms and a clinical diagnosis at ≥21 years of age).\n* A diagnosis based on clinical features and the presence of ≥40 CAG repeats in the huntingtin (HTT) gene confirmed by historical laboratory quanitified results or by a diagnostic test at Screening.\n* Diagnostic confidence level (DCL) of 4 (DCL=4 unequivocal motor signs, ≥99% confidence) on the standardized motor exam Total Motor Score (TMS).\n* Total Functional Capacity (TFC) score of ≥7 at Screening and Baseline.\n* Cytosine-Adenine-Guanine (CAG)-Age Product (CAP)100 score ≥95 at Screening.\n* Independence Scale (IS) score ≤90% at Screening.\n* Total Motor Score (TMS) of ≥20 at Screening and Baseline.\n* Not using ADMs (VMAT2i and neuroleptics\u002Fantipsychotics) for at least 6 months prior to Screening visit. Importantly, it is not encouraged to discontinue the participants' ADM treatment solely for enrollment in the current trial.\n\nExclusion Criteria:\n\n* Clinically significant cardiovascular disease (e.g. QTcF \\>450 msec \\[males\\] or \\>470 msec \\[females\\], arrhythmias, uncontrolled atrial fibrillation, or congenital long QT syndrome), seizure history ≤5 years, significant neurological disorders (e.g. intracranial pathology or cerebrovascular events), active\u002Frecent malignancy (unless localized and resolved), or any serious or uncontrolled systemic disease (e.g. hepatic, renal, respiratory, endocrine, infectious \\[HBV, HCV, HIV\\], or psychiatric) that may pose safety risk or interfere with participation.\n* Severe hepatic or renal impairment.\n* Any mutant huntingtin (mHTT) lowering therapy in the past year.\n* Medications that prolong QT interval, taken within 4 weeks of the baseline visit.\n* Use of pridopidine within 6 weeks or 5 half-lives before the screening visit.\n* Previous participation in intracranial gene therapy study.\n* Laboratory values that fall outside of the central laboratory's reference range at Screening and are considered clinically significantly abnormal by the Investigator and affect the participant's suitability to participate in the study or put the participant at risk if he\u002Fshe enters the study in the Investigator's opinion.\n* Female participants who are pregnant, planning to become pregnant or breastfeeding.","23 Years","65 Years",{"count":53,"type":22},400,[25],"The goal of this clinical trial is to learn if pridopidine can slow the clinical decline of Huntington's Disease (HD) in adult participants. It will also inform about the safety of pridopidine.\n\nThe main questions the study aims to answer are:\n\nDoes pridopidine slow the overall worsening of HD over 1 year? Does pridopidine slow the worsening of specific aspects of HD over 1 year, namely the clinical progression, the ability to perform daily life activities (functional capacity), the mind's ability to process information (cognition), working of the muscles (motor function), and quality of life?\n\nResearchers will compare the drug pridopidine to a placebo (a look-alike substance that contains no drug) to see if pridopidine works better than placebo to treat HD. During the first year of the study, participants will have the same chance to receive either pridopidine or placebo.\n\nParticipants will:\n\nTake 1 pridopidine or placebo capsule twice daily for 12 months. Visit the clinic 6 times within 1 year for checkups and tests.\n\nAll participants who complete this 1-year placebo-controlled study period will roll over into an additional 2-year study period during which all participants will receive pridopidine treatment, including participants who had received placebo during the first year. During this additional 2-year treatment period participants will visit the clinic a total of 6 times for checkups and tests.",[57],"Huntington Disease","NOT_YET_RECRUITING","2026-05-29",{"date":61,"type":33},"2026-06-02",{"date":63,"type":22},"2026-06",{"date":65,"type":22},"2030-06",{"name":39,"class":40},""]