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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
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

Full criteria on ClinicalTrials.gov

Sites (56)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UZ Leuven
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LeuvenBelgiumRecruiting
University of Alberta
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EdmontonCanadaRecruiting
McMaster University Medical Centre
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HamiltonCanadaRecruiting
Genge Partners
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MontrealCanadaRecruiting
ALS outpatient department at Charité - university medicine Berlin
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BerlinGermanyRecruiting
ALS Clinic Bonn University
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BonnGermanyRecruiting
Medical School Hannover, ALS Centre
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HanoverGermanyRecruiting
University Hospital Jena
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JenaGermanyRecruiting
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
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LübeckGermanyRecruiting
University of Ulm
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UlmGermanyRecruiting
University Hospital of Bellvitge
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BarcelonaSpainRecruiting
Hospital del Mar
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BarcelonaSpainRecruiting
Hospital Universitario La Paz - Carlos III
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MadridSpainRecruiting
Clinical Hospital Santiago de Compostela
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Santiago de CompostelaSpainRecruiting
Hospital Universitari i Politécnic La Fe
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ValenciaSpainRecruiting
CHU Lille
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LilleFranceRecruiting
Hôpitaux Universitaires de Marseille Timone
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MarseilleFranceRecruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceRecruiting
Hospitalier Pitie-Salpetriere
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ParisFranceRecruiting
Centre hospitalier régional universitaire de de Tours
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ToursFranceRecruiting
King's College Hospital
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LondonUnited KingdomRecruiting
MDN Centre Queen Square Institute of Neurology
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LondonUnited KingdomRecruiting
Royal Stoke University Hospital
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Stoke-on-TrentUnited KingdomRecruiting
Trinity College Dublin
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DublinIrelandRecruiting
Hadassah medical Center
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JerusalemIsraelRecruiting
Tel-Aviv Sourasky Medical Center
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Tel AvivIsraelRecruiting
University of Campania "Luigi Vanvitelli"
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CasertaItalyRecruiting
Istituto Auxologico Italiano Ospedale San Luca
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MilanItalyRecruiting
Centro Clinico NEMO Fondazione Serena Onlus - ASST Niguarda Hospital
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MilanItalyRecruiting
Azienda Ospedaliero - Universitaria di Modena
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ModenaItalyRecruiting
University of Padova
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PadovaItalyRecruiting
University of Torino
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TorinoItalyRecruiting
UMC Utrecht
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UtrechtNetherlandsRecruiting
Centrum Medyczne NEUROMED
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BydgoszczPolandRecruiting
Linden sp. z o.o. sp. k.
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KrakowPolandRecruiting
City Clinic Research Sp. z o.o.
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WarsawPolandRecruiting
Studieenheten Akademiskt specialistcentrum
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StockholmSwedenRecruiting
Umeå University Hospital
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UmeåSwedenRecruiting
Emory University
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AtlantaUnited StatesRecruiting
University of Colorado CU Anschutz Neurology
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AuroraUnited StatesRecruiting
Johns Hopkins University
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BaltimoreUnited StatesRecruiting
Sean M. Healey & AMG Center for ALS
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BostonUnited StatesRecruiting
Northwestern University
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ChicagoUnited StatesRecruiting
Texas Neurology
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DallasUnited StatesRecruiting
University of Kansas
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FairwayUnited StatesRecruiting
Baylor College of Medicine; McNair Medical Campus
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HoustonUnited StatesRecruiting
Mayo Clinic
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JacksonvilleUnited StatesRecruiting
Somnos Clinical Research
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LincolnUnited StatesRecruiting
Eleanor and Lou Gehrig ALS Center at Columbia University
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New YorkUnited StatesRecruiting
Neuroscience Department at LKSM at Temple University
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PhiladelphiaUnited StatesRecruiting
Barrow Neurological Institute
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PhoenixUnited StatesRecruiting
California Pacific Medical Center
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San FranciscoUnited StatesRecruiting
Swedish Medical Center
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SeattleUnited StatesRecruiting
University of Washington
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SeattleUnited StatesRecruiting
Washington University
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St LouisUnited StatesRecruiting
University of South Florida
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TampaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.