NCT07322003RecruitingPhase 3
Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants With Amyotrophic Lateral Sclerosis
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 5 Jan 2026
- Start date
- 1 Feb 2026
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- Prilenia
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT07322003
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 500
- From 1 Feb 2026 to the primary completion date, 31 Mar 2028
- 56 sites in 13 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with pridopidine, gene therapy, or antisense oligonucleotides.
Other illness
- 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.
Lab values
- Use of medications that prolong QT interval.
Other
- Presence of tracheostomy or permanent assisted ventilation.
- Confirmed mutation in the SOD1, FUS or C9orf72 gene.
- Pregnancy.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (56)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| University of Alberta Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| McMaster University Medical Centre Coordinator of this site? Confirm its status | Hamilton | Canada | Recruiting |
| Genge Partners Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| ALS outpatient department at Charité - university medicine Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| ALS Clinic Bonn University Coordinator of this site? Confirm its status | Bonn | Germany | Recruiting |
| Medical School Hannover, ALS Centre Coordinator of this site? Confirm its status | Hanover | Germany | Recruiting |
| University Hospital Jena Coordinator of this site? Confirm its status | Jena | Germany | Recruiting |
| Universitaetsklinikum Schleswig-Holstein - Campus Luebeck Coordinator of this site? Confirm its status | Lübeck | Germany | Recruiting |
| University of Ulm Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| University Hospital of Bellvitge Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario La Paz - Carlos III Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Clinical Hospital Santiago de Compostela Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
| Hospital Universitari i Politécnic La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| CHU Lille Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Hôpitaux Universitaires de Marseille Timone Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Hospitalier Pitie-Salpetriere Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Centre hospitalier régional universitaire de de Tours Coordinator of this site? Confirm its status | Tours | France | Recruiting |
| King's College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| MDN Centre Queen Square Institute of Neurology Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Royal Stoke University Hospital Coordinator of this site? Confirm its status | Stoke-on-Trent | United Kingdom | Recruiting |
| Trinity College Dublin Coordinator of this site? Confirm its status | Dublin | Ireland | Recruiting |
| Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| University of Campania "Luigi Vanvitelli" Coordinator of this site? Confirm its status | Caserta | Italy | Recruiting |
| Istituto Auxologico Italiano Ospedale San Luca Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Centro Clinico NEMO Fondazione Serena Onlus - ASST Niguarda Hospital Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Recruiting |
| University of Padova Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| University of Torino Coordinator of this site? Confirm its status | Torino | Italy | Recruiting |
| UMC Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
| Centrum Medyczne NEUROMED Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Linden sp. z o.o. sp. k. Coordinator of this site? Confirm its status | Krakow | Poland | Recruiting |
| City Clinic Research Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Studieenheten Akademiskt specialistcentrum Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
| Umeå University Hospital Coordinator of this site? Confirm its status | Umeå | Sweden | Recruiting |
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| University of Colorado CU Anschutz Neurology Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Sean M. Healey & AMG Center for ALS Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Texas Neurology Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| University of Kansas Coordinator of this site? Confirm its status | Fairway | United States | Recruiting |
| Baylor College of Medicine; McNair Medical Campus Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Somnos Clinical Research Coordinator of this site? Confirm its status | Lincoln | United States | Recruiting |
| Eleanor and Lou Gehrig ALS Center at Columbia University Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Neuroscience Department at LKSM at Temple University Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Barrow Neurological Institute Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| California Pacific Medical Center Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Swedish Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| University of South Florida Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.