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Each function is scored from 0 (no ability) to 4 (normal), with a minimum total score of 0 and maximum total score of 48. 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The score ranges from 0 to 100; the higher the score, the worse the quality of life.",{"allocation":34,"interventionModel":35,"interventionModelDescription":36,"primaryPurpose":37,"observationalModel":20,"timePerspective":20,"maskingInfo":38},"RANDOMIZED","PARALLEL","Randomized (3:2), double-blind, placebo-controlled study followed by an open-label extension period. During the open-label extension, all participants will receive pridopidine.","TREATMENT",{"masking":39,"maskingDescription":20,"whoMasked":40},"QUADRUPLE",[41,42,43,44],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This is a Phase 3, randomized study consisting of a double-blind placebo-controlled (DBPC) period followed by an open-label extension (OLE) to evaluate the efficacy and safety of pridopidine administered orally at a dose of 45 mg twice a day in adult participants with early and rapidly progressing ALS. Standard of care treatments (e.g. riluzole, edaravone and Nuedexta) will be allowed as long as participants are on a stable dose for at least 4 weeks prior to dosing. In the DBPC period, participants will be randomized in a 3:2 ratio to the pridopidine and placebo arms.\n\nIn the DBPC period, participants will receive pridopidine or placebo for 48 weeks. In the OLE period, all participants will receive pridopidine for 48 weeks, while maintaining the blind to their original randomization for both the participant as well as the Investigator and other clinical staff. The total study duration per participant will be 102 weeks including screening and follow up.\n\nThroughout the study, participants will be assessed through on-site clinic visits and virtual visits (via telephone).",[47,53],{"label":48,"type":49,"description":50,"interventionNames":51},"Pridopidine","EXPERIMENTAL","Pridopidine hard gelatin capsules of 45 mg strength. 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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",[745],"Amyotrophic Lateral Sclerosis","2026-08-24",{"date":748,"type":749},"2026-08-25","ACTUAL",{"date":751,"type":749},"2026-02-01",{"date":753,"type":739},"2029-03",{"name":5,"class":6},56]