RECRUITING
Phase 3
ClinicalTrials.gov
Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS
Sponsor: Prilenia • ClinicalTrials.gov ID: NCT07322003
Registry updated: 2026-10-06
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Check Eligibility →Description
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
Interventions
-
Pridopidine
(Drug)
Pridopidine hard gelatin capsule.
-
Placebo
(Drug)
Placebo hard gelatin capsule.
Eligibility criteria
Key Inclusion Criteria:
* 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.
Key Exclusion Criteria:
* Presence of tracheostomy or permanent assisted ventilation.
* Clinically significant heart disease, clinically significant history of arrhythmia, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia, or presence of left bundle branch block.
* Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide informed consent and participate in the study.
* Clinically significant and/or unstable medical condition (other than ALS) that may either pose a clinically meaningful risk to the participant and/or to study completion.
* Use of medications that prolong QT interval.
* Previous treatment with pridopidine, gene therapy, or antisense oligonucleotides.
* Confirmed mutation in the SOD1, FUS or C9orf72 gene.
* Pregnancy.
Conditions
Amyotrophic Lateral Sclerosis
Locations
- 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 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
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Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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