Find Primary Lateral Sclerosis Clinical Trials Near You
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants With Amyotrophic Lateral Sclerosis
Status: Recruiting
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Definite ALS or Probable ALS using the El Escorial criteria.
• Symptom onset of ≤18 months at screening.
• Slow vital capacity (SVC) greater or equal to 60% predicted.
• Treatment Research Initiative to Cure ALS (TRICALS) Risk Profile Calculator score, based on the European Network for the Cure of ALS (ENCALS) survival prediction model, in the range of -6 to -2, inclusive, at screening.
• Able to swallow a capsule.
Locations
United States
California
California Pacific Medical Center
RECRUITING
San Francisco
Florida
University of South Florida
RECRUITING
Florida City
Georgia
Emory University
RECRUITING
Atlanta
Illinois
Northwestern University
RECRUITING
Chicago
Kansas
University of Kansas
RECRUITING
Fairway
Massachusetts
Sean M. Healey & AMG Center for ALS
RECRUITING
Boston
Missouri
Washington University
RECRUITING
St Louis
Nebraska
Somnos Clinical Research
RECRUITING
Lincoln
New York
Eleanor and Lou Gehrig ALS Center at Columbia University
RECRUITING
New York
Pennsylvania
Neuroscience Department at LKSM at Temple University
RECRUITING
Philadelphia
Texas
Texas Neurology
RECRUITING
Dallas
Baylor College of Medicine; McNair Medical Campus
RECRUITING
Houston
Washington
Swedish Medical Center
RECRUITING
Seattle
University of Washington
RECRUITING
Seattle
Other Locations
Belgium
UZ Leuven
RECRUITING
Leuven
Canada
Genge Partners
RECRUITING
Montreal
Germany
ALS Clinic Bonn University
RECRUITING
Bonn
Netherlands
UMC Utrecht
RECRUITING
Utrecht
Poland
Centrum Medyczne Neuromed
RECRUITING
Bydgoszcz
Linden sp. z o. o. sp. k.
RECRUITING
Krakow
City Clinic Research Sp. z o.o.
RECRUITING
Warsaw
Spain
Hospital Universitari i Politècnic La Fe
RECRUITING
Valencia
Sweden
Umeå University Hospital
RECRUITING
Solna
Studieenheten Akademiskt specialistcentrum
RECRUITING
Stockholm
Contact Information
Primary
Executive Director Clinical Operations
MedInfo@prilenia.com
857-574-5755
Time Frame
Start Date:2026-02-01
Estimated Completion Date:2029-03
Participants
Target number of participants:500
Treatments
Experimental: Pridopidine
Pridopidine hard gelatin capsules of 45 mg strength. During titration period 1 capsule taken orally in the morning for 2 weeks. During the main treatment period, 1 capsule in the morning and 1 capsule in the afternoon taken orally. Total daily dose of 90 mg.
Placebo_comparator: Placebo
Placebo hard gelatin capsules. During titration period 1 capsule taken orally in the morning for 2 weeks. During the main treatment period, 1 capsule in the morning and 1 capsule in the afternoon taken orally.