Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Amyotrophic Lateral Sclerosis
In brief
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
Key facts
- Study ID
- NCT07322003
- Run by
- Prilenia
- People needed
- 500
- Starts
- 2026-02-01
- Expected to finish
- 2029-03-01
- Last updated by the study team
- 2026-08-04
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Centre hospitalier régional universitaire de de Tours — Tours, France (enrolling)
- ALS outpatient department at Charité - university medicine Berlin — Berlin, Germany (enrolling)
- Mayo Clinic — Jacksonville, Florida, United States (enrolling)
- Hospitalier Pitié-Salpêtrière — Paris, France (enrolling)
- University of Colorado CU Anschutz Neurology — Aurora, Colorado, United States (enrolling)
- Northwestern University — Chicago, Illinois, United States (enrolling)
- University of Kansas — Fairway, Kansas, United States (enrolling)
- Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
- University of South Florida — Tampa, Florida, United States (enrolling)
- Barrow Neurological Institute — Phoenix, Arizona, United States (enrolling)
- Emory University — Atlanta, Georgia, United States (enrolling)
- Eleanor and Lou Gehrig ALS Center at Columbia University — New York, New York, United States (enrolling)
- Neuroscience Department at LKSM at Temple University — Philadelphia, Pennsylvania, United States (enrolling)
- Texas Neurology — Dallas, Texas, United States (enrolling)
- Baylor College of Medicine; McNair Medical Campus — Houston, Texas, United States (enrolling)
- Swedish Medical Center — Seattle, Washington, United States (enrolling)
- University of Washington — Seattle, Washington, United States (enrolling)
- UZ Leuven — Leuven, Belgium (enrolling)
- Genge Partners — Montreal, Quebec, Canada (enrolling)
- Sean M. Healey & AMG Center for ALS — Boston, Massachusetts, United States (enrolling)
- Washington University — St Louis, Missouri, United States (enrolling)
- California Pacific Medical Center — San Francisco, California, United States (enrolling)
- Somnos Clinical Research — Lincoln, Nebraska, United States (enrolling)
- Centre Hospitalier Universitaire de Nice — Nice, France (enrolling)
- ALS outpatient department at Charité - university medicine Berlin — Berlin, Germany (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.