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Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS
Sponsor: Prilenia
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
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants With Amyotrophic Lateral Sclerosis
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2026-02-01
Completion Date
2029-03
Last Updated
2026-08-25
Healthy Volunteers
No
Conditions
Interventions
Pridopidine
Pridopidine hard gelatin capsule.
Placebo
Placebo hard gelatin capsule.
Locations (56)
Barrow Neurological Institute
Phoenix, Arizona, United States
California Pacific Medical Center
San Francisco, California, United States
University of Colorado CU Anschutz Neurology
Aurora, Colorado, United States
Mayo Clinic
Jacksonville, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Kansas
Fairway, Kansas, United States
Johns Hopkins University
Baltimore, Maryland, United States
Sean M. Healey & AMG Center for ALS
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
Somnos Clinical Research
Lincoln, Nebraska, United States
Eleanor and Lou Gehrig ALS Center at Columbia University
New York, New York, United States
Neuroscience Department at LKSM at Temple University
Philadelphia, Pennsylvania, United States
Texas Neurology
Dallas, Texas, United States
Baylor College of Medicine; McNair Medical Campus
Houston, Texas, United States
Swedish Medical Center
Seattle, Washington, United States
University of Washington
Seattle, Washington, United States
UZ Leuven
Leuven, Belgium
Genge Partners
Montreal, Quebec, Canada
University of Alberta
Edmonton, Canada
McMaster University Medical Centre
Hamilton, Canada
CHU Lille
Lille, France
Hôpitaux Universitaires de Marseille Timone
Marseille, France
Centre Hospitalier Universitaire de Nice
Nice, France
Hospitalier Pitié-Salpêtrière
Paris, France
Centre hospitalier régional universitaire de de Tours
Tours, France
ALS outpatient department at Charité - university medicine Berlin
Berlin, Germany
ALS outpatient department at Charité - university medicine Berlin
Berlin, Germany
ALS Clinic Bonn University
Bonn, Germany
University Hospital Jena
Jena, Germany
Universitätsklinikum Schleswig-Holstein
München, Germany
University of Ulm
Ulm, Germany
Trinity College Dublin
Dublin, Ireland
Hadassah Medical Center
Jerusalem, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
University of Campania "Luigi Vanvitelli"
Caserta, Italy
Centro Clinico NEMO Fondazione Serena Onlus - ASST Niguarda Hospital
Milan, Italy
Istituto Auxologico Italiano Ospedale San Luca
Milan, Italy
Azienda Ospedaliero Universitaria Di Modena
Modena, Italy
University of Padova
Padova, Italy
University of Torino
Torino, Italy
UMC Utrecht
Utrecht, Netherlands
Centrum Medyczne Neuromed
Bydgoszcz, Poland
Linden sp. z o. o. sp. k.
Krakow, Poland
City Clinic Research Sp. z o.o.
Warsaw, Poland
Hospital del Mar
Barcelona, Spain
University Hospital of Bellvitge
Barcelona, Spain
Hospital Universitario La Paz - Carlos III
Madrid, Spain
Clinical Hospital Santiago de Compostela
Santiago de Compostela, Spain
Hospital Universitari i Politècnic La Fe
Valencia, Spain
Studieenheten Akademiskt specialistcentrum
Stockholm, Sweden
Umeå University Hospital
Umeå, Sweden
King's College Hospital
London, United Kingdom
MDN Centre Queen Square Institute of Neurology
London, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom