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 (56) 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
Arizona
Barrow Neurological Institute
RECRUITING
Phoenix
California
California Pacific Medical Center
RECRUITING
San Francisco
Colorado
University of Colorado CU Anschutz Neurology
RECRUITING
Aurora
Florida
Mayo Clinic
RECRUITING
Jacksonville
University of South Florida
RECRUITING
Tampa
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
Maryland
Johns Hopkins University
RECRUITING
Baltimore
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
University of Alberta
RECRUITING
Edmonton
McMaster University Medical Centre
NOT_YET_RECRUITING
Hamilton
Genge Partners
RECRUITING
Montreal
France
CHU Lille
RECRUITING
Lille
Hôpitaux Universitaires de Marseille Timone
NOT_YET_RECRUITING
Marseille
Centre Hospitalier Universitaire de Nice
RECRUITING
Nice
Hospitalier Pitié-Salpêtrière
RECRUITING
Paris
Centre hospitalier régional universitaire de de Tours
RECRUITING
Tours
Germany
ALS outpatient department at Charité - university medicine Berlin
RECRUITING
Berlin
ALS outpatient department at Charité - university medicine Berlin
RECRUITING
Berlin
ALS Clinic Bonn University
RECRUITING
Bonn
University Hospital Jena
RECRUITING
Jena
Universitätsklinikum Schleswig-Holstein
RECRUITING
München
University of Ulm
RECRUITING
Ulm
Ireland
Trinity College Dublin
RECRUITING
Dublin
Israel
Hadassah Medical Center
RECRUITING
Jerusalem
Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Italy
University of Campania Luigi Vanvitelli
RECRUITING
Caserta
Centro Clinico NEMO Fondazione Serena Onlus - ASST Niguarda Hospital
RECRUITING
Milan
Istituto Auxologico Italiano Ospedale San Luca
RECRUITING
Milan
Azienda Ospedaliero Universitaria Di Modena
RECRUITING
Modena
University of Padova
RECRUITING
Padova
University of Torino
NOT_YET_RECRUITING
Torino
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 del Mar
RECRUITING
Barcelona
University Hospital of Bellvitge
RECRUITING
Barcelona
Hospital Universitario La Paz - Carlos III
RECRUITING
Madrid
Clinical Hospital Santiago de Compostela
RECRUITING
Santiago De Compostela
Hospital Universitari i Politècnic La Fe
RECRUITING
Valencia
Sweden
Studieenheten Akademiskt specialistcentrum
RECRUITING
Stockholm
Umeå University Hospital
RECRUITING
Umeå
United Kingdom
King's College Hospital
RECRUITING
London
MDN Centre Queen Square Institute of Neurology
RECRUITING
London
Royal Stoke University Hospital
RECRUITING
Stoke-on-trent
Contact Information
Primary
Prilenia Medical Information
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.
Related Therapeutic Areas
Sponsors
Collaborators: Ferrer Internacional S.A.
Leads: Prilenia