Phase 3RecruitingAge-related condition
Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS (PREVAiLS)
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants With Amyotrophic Lateral Sclerosis
- Sponsor
- Prilenia (Industry)
- Enrolment
- 500 planned
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- Pridopidine; Placebo
- Ages
- adults, older adults
- Registry
- NCT07322003
Full record on ClinicalTrials.gov
From the registry
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
Primary outcomes
- Change from baseline through Week 26 and Week 48 in the Revised ALS Functional Rating Scale (ALSFRS-R) total score adjusted for mortality
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered