Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS (PREVAiLS)
Research type
Research Study
Full title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants with Amyotrophic Lateral Sclerosis
IRAS ID
1013269
Contact name
Rebecca Aldonza
Contact email
Sponsor organisation
Prilenia Therapeutics BV / Ferrer internacional SA
Research summary
There is currently no cure for ALS and current therapies have a limited benefit in the general ALS population. There remains a high unmet need for highly effective disease-modifying drugs for the treatment of ALS.
The results from completed studies with pridopidine suggest a potential benefit of pridopidine to fulfill an unmet need in the treatment of individuals with ALS, and support further clinical development.
Participants in the study may experience symptomatic improvement and, possibly, the rate of disease progression may be reduced.
This study is a Phase 3, Randomized, Double-blind, Placebo-controlled (DBPC) study meaning that each participant will be randomly assigned to receive either pridopidine or matching placebo.
The study participation will take approximately 25 months (up to 4 weeks of screening, 48 weeks of DBPC treatment, 48 of OLE treatment period and 2 weeks of safety follow-up). There will be several assessments (such as medical history, physical exams, vital signs, ECG, blood/urine samples and questionnaires) to be completed.REC name
London - Riverside Research Ethics Committee
REC reference
26/LO/0097
Date of REC Opinion
4 Mar 2026
REC opinion
Further Information Favourable Opinion