Clinical Trial

Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS

Study acronym: PREVAiLS
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
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: Does pridopidine slow disease progression of ALS? Researchers will compare pridopidine to a placebo (a look-alike substance that contains no drug) to see if pridopidine works to treat ALS. Participants will: Take pridopidine or a placebo by mouth every day for 48 weeks. Afterwards, all participants will take pridopidine for another 48 weeks. Visit the clinic once every 1-3 months for checkups and tests
Protocol Amendment History 7 changes
notable Trial sites expanded: 47 -> 56 locations 2026-07-30
notable Trial sites expanded: 44 -> 47 locations 2026-07-29
notable Trial sites expanded: 36 -> 44 locations 2026-07-24
notable Trial sites expanded: 32 -> 35 locations 2026-07-09
notable Trial sites expanded: 24 -> 28 locations 2026-06-25
notable Trial sites expanded: 16 -> 24 locations 2026-06-19
notable Trial sites expanded: 5 -> 16 locations 2026-06-10
Trial Details
NCT Number NCT07322003
Lead Sponsor Prilenia
Collaborators: Ferrer Internacional S.A.
Conditions Amyotrophic Lateral Sclerosis
Enrollment 500 participants
Start Date 2026-02-01
Primary Completion 2028-03 (estimated)
Study Completion 2029-03 (estimated)
Updated on ClinicalTrials.gov 2026-08-11