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Can pridopidine slow ALS? major trial underway

NCT ID NCT07322003

Disease control Sponsor: Prilenia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 16, 2026 · Updated 20 times

Summary

This phase 3 trial is testing whether the drug pridopidine can slow the progression of amyotrophic lateral sclerosis (ALS) in 500 adults. Participants will take either pridopidine or a placebo daily for 48 weeks, followed by an open-label extension where everyone receives the drug. The study measures changes in physical function and survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pridopidine
What this could lead to
If it works, this could point toward a treatment that slows the progression of ALS, helping people maintain function longer.
What could go wrong
This is a late-stage trial, but ALS is a tough disease and many promising drugs have failed before. The drug may not slow progression or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amyotrophic lateral sclerosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    55 sites in 13 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • ALS Clinic Bonn University

    RECRUITING

    Bonn, 53127, Germany

  • ALS outpatient department at Charité - university medicine Berlin

    RECRUITING

    Berlin, 13353, Germany

  • Azienda Ospedaliero Universitaria Di Modena

    RECRUITING

    Modena, Italy

  • Barrow Neurological Institute

    RECRUITING

    Phoenix, Arizona, 85013, United States

  • Baylor College of Medicine; McNair Medical Campus

    RECRUITING

    Houston, Texas, 77030, United States

  • CHU Lille

    RECRUITING

    Lille, France

  • California Pacific Medical Center

    RECRUITING

    San Francisco, California, 94109, United States

    Contact Email: •••••@•••••

  • Centre Hospitalier Universitaire de Nice

    RECRUITING

    Nice, France

  • Centre hospitalier régional universitaire de de Tours

    RECRUITING

    Tours, France

  • Centro Clinico NEMO Fondazione Serena Onlus - ASST Niguarda Hospital

    RECRUITING

    Milan, 20126, Italy

  • Centrum Medyczne Neuromed

    RECRUITING

    Bydgoszcz, 85-163, Poland

  • City Clinic Research Sp. z o.o.

    RECRUITING

    Warsaw, 02-473, Poland

    Contact Email: •••••@•••••

  • Clinical Hospital Santiago de Compostela

    RECRUITING

    Santiago de Compostela, 15706, Spain

  • Eleanor and Lou Gehrig ALS Center at Columbia University

    RECRUITING

    New York, New York, 10032, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Genge Partners

    RECRUITING

    Montreal, Quebec, H4P 2N2, Canada

  • Hadassah Medical Center

    RECRUITING

    Jerusalem, IL 91120, Israel

  • Hospital Universitari i Politècnic La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario La Paz - Carlos III

    RECRUITING

    Madrid, 28029, Spain

  • Hospital del Mar

    RECRUITING

    Barcelona, Spain

  • Hospitalier Pitié-Salpêtrière

    RECRUITING

    Paris, 75013, France

  • Hôpitaux Universitaires de Marseille Timone

    RECRUITING

    Marseille, France

  • Istituto Auxologico Italiano Ospedale San Luca

    RECRUITING

    Milan, Italy

  • Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21205, United States

  • King's College Hospital

    RECRUITING

    London, United Kingdom

  • Linden sp. z o. o. sp. k.

    RECRUITING

    Krakow, 30-105, Poland

  • MDN Centre Queen Square Institute of Neurology

    RECRUITING

    London, United Kingdom

  • Mayo Clinic

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • McMaster University Medical Centre

    NOT_YET_RECRUITING

    Hamilton, Canada

  • Neuroscience Department at LKSM at Temple University

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Royal Stoke University Hospital

    RECRUITING

    Stoke-on-Trent, ST4 6QG, United Kingdom

  • Sean M. Healey & AMG Center for ALS

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Somnos Clinical Research

    RECRUITING

    Lincoln, Nebraska, 68506, United States

  • Studieenheten Akademiskt specialistcentrum

    RECRUITING

    Stockholm, 113 61, Sweden

  • Swedish Medical Center

    RECRUITING

    Seattle, Washington, 98122, United States

  • Tel Aviv Sourasky Medical Center

    RECRUITING

    Tel Aviv, 6423906, Israel

  • Texas Neurology

    RECRUITING

    Dallas, Texas, 75206, United States

  • Trinity College Dublin

    RECRUITING

    Dublin, Ireland

  • UMC Utrecht

    RECRUITING

    Utrecht, Netherlands

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • Umeå University Hospital

    RECRUITING

    Umeå, 901 85, Sweden

  • University Hospital Jena

    RECRUITING

    Jena, Germany

  • University Hospital of Bellvitge

    RECRUITING

    Barcelona, Spain

  • University of Alberta

    RECRUITING

    Edmonton, Canada

  • University of Campania "Luigi Vanvitelli"

    RECRUITING

    Caserta, Italy

  • University of Colorado CU Anschutz Neurology

    RECRUITING

    Aurora, Colorado, 80045, United States

    Contact Email: •••••@•••••

  • University of Kansas

    RECRUITING

    Fairway, Kansas, 66205, United States

  • University of Padova

    RECRUITING

    Padova, Italy

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33612, United States

  • University of Torino

    NOT_YET_RECRUITING

    Torino, Italy

  • University of Ulm

    RECRUITING

    Ulm, 89081, Germany

  • University of Washington

    RECRUITING

    Seattle, Washington, 98195, United States

  • Universitätsklinikum Schleswig-Holstein

    RECRUITING

    München, Germany

  • Washington University

    RECRUITING

    St Louis, Missouri, 63110, United States

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Other studies related to the condition(s) this trial covers.