drugset / Trial / NCT07322003

Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS

NCT07322003

Phase 3 Recruiting 500 enrolled Prilenia Ferrer Internacional S.A. · collab
RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start
2026-02-01
Primary completion
2028-03
Completion
2029-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Pridopidine Small molecule 45 mg Oral