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Hope for ALS patients: new drug combo enters final testing phase

NCT ID NCT03127267

Disease control Sponsor: AB Science 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This Phase 3 trial is testing whether adding masitinib to the standard ALS drug riluzole can slow the disease better than riluzole alone. About 495 people with ALS will take either masitinib or a placebo, plus riluzole, and researchers will track changes in muscle function, breathing, and quality of life over time.

What this could mean

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

Active substance
masitinib (a drug) taken with riluzole
What this could lead to
If successful, this could provide a new treatment option to slow the progression of ALS and extend quality of life for patients.
What could go wrong
This is a Phase 3 trial, but ALS is a complex disease and previous treatments have failed. Masitinib may not show significant benefit 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 495 people

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

Started

Feb 2021

Expected to finish

Dec 2027

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 81 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.

Main inclusion criteria include: * Patients diagnosed with laboratory supported probable, clinically probable or definite ALS according to the World Federation of Neurology Revised El Escorial criteria * Patient with a familial or sporadic ALS * ALS disease duration from diagnosis no longer than 24 months at the screening visit * Patient treated with a stable dose of riluzole (100 mg/day) for at least 12 weeks days prior to the baseline visit * Patient with an ALSFRS-R score progression between onset of the disease and screening of \> 0.3 per month, confirmed with an ALSFRS-R score progression of ≥ 1 point during a 12-week run-in period between screening and randomization. * Patient with a score, at screening, of at least 26 overall, including a score of at least 3 on item #3 and at least 2 on each of the 12 ALSFRS-R individual component items and with a score, at randomization, of at least 2 on each of the 12 ALSFRS-R individual component items Main exclusion criteria include: * Patient with dementia or significant neurological, psychiatric, systemic or organic disease, uncontrolled or that may interfere with the conduct of the trial or its results * Patient with a FVC \< 60% predicted normal value for gender, height, and age at screening and baseline * Pregnant, or nursing female patient

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis motor neuron disorder

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 places running it

    56 sites in 17 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • ASST degli Spedali Civili di Brescia

    RECRUITING

    Brescia, Italy

  • Athens Naval Hospital

    RECRUITING

    Athens, Greece

  • Azienda Ospedale-Università Padova

    RECRUITING

    Padova, Italy

  • Bispebjerg Hospital

    RECRUITING

    Copenhagen, Denmark

  • CHRU de Montpellier - Gui de Chauliac

    RECRUITING

    Montpellier, France

  • CHRU de Tours - Hopital Bretonneau

    RECRUITING

    Tours, France

  • CHU Gabriel Montpied

    RECRUITING

    Clermont-Ferrand, France

  • CHU Hôpital Pasteur Nice

    RECRUITING

    Nice, France

  • CHU de Angers

    RECRUITING

    Angers, France

  • CHU de Lille - Hopital Roger Salengro

    RECRUITING

    Lille, France

  • CHU de Limoges - Hôpital Dupuytren

    RECRUITING

    Limoges, France

  • CHU de Marseille - Hôpital de la Timone

    RECRUITING

    Marseille, France

  • CHU de Nancy - Hopital Central

    RECRUITING

    Nancy, France

  • Centralsjukhuset Karlstad (Central Hospital Karlstad)

    RECRUITING

    Karlstad, Sweden

  • Centro Clinico NeMO Fondazione Serena Onlus

    RECRUITING

    Gussago, Italy

  • Centrum Medyczne Neuromed

    RECRUITING

    Bydgoszcz, Poland

  • Clinical Centre of Serbia

    RECRUITING

    Belgrade, Serbia

  • Clinical Hospital Santiago de Compostela

    RECRUITING

    Santiago de Compostela, Spain

  • Clinico Nemo Center (Centro Clinico NeMO Milano)

    RECRUITING

    Milan, Italy

  • Communal Non-Profit Enterprise of Lviv Regional Council, Lviv Regional Clinical Hospital, Neurological Department

    RECRUITING

    Lviv, Ukraine

  • Department of Neurology, University of Ulm

    NOT_YET_RECRUITING

    Ulm, 89081, Germany

  • Eginition Hospital

    RECRUITING

    Athens, Greece

  • General University Hospital of Patras

    RECRUITING

    Rio, Greece

  • Groupe Hospitalier Pellegrin Tripode

    RECRUITING

    Bordeaux, France

  • Hadassah University Hospital

    RECRUITING

    Jerusalem, Israel

  • Hospital Carlos III

    RECRUITING

    Madrid, Spain

  • Hospital General Universitario de Alicante

    RECRUITING

    Alicante, Spain

  • Hospital San Rafael

    RECRUITING

    Madrid, Spain

  • Hospital Universitari de Bellvitge

    RECRUITING

    Barcelona, Spain

  • Hospital Universitario y Politecnico La Fe

    RECRUITING

    Valencia, Spain

  • Hospital de Santa Maria

    RECRUITING

    Lisbon, Portugal

  • Hôpital neurologique Pierre Wertheimer

    RECRUITING

    Bron, France

  • IRCCS Istituto Auxologico Italiano

    RECRUITING

    Milan, Italy

  • IRCCS Mondino Foundation

    RECRUITING

    Pavia, Italy

  • Istituti Clinici Scientifici Maugeri IRCCS

    RECRUITING

    Milan, Italy

  • Johns Hopkins Medicine Brain Science Institute

    RECRUITING

    Baltimore, Maryland, 21205, United States

  • Klinicni center Ljubljana

    RECRUITING

    Ljubljana, Slovenia

  • Lahey Hospital and Medical Center

    RECRUITING

    Burlington, Massachusetts, 01805, United States

  • Medical Center of LLC Medical Center Dopomoga Plus

    RECRUITING

    Kyiv, Ukraine

  • Moscow city clinical Hospital after V.M. Buyanov

    RECRUITING

    Moscow, Russia

  • Norrlands universitetssjukhus

    RECRUITING

    Umeå, Sweden

  • Oslo University Hospital HF Ullevål

    RECRUITING

    Oslo, Norway

  • Ospedale Civile Sant'Agostino - Estense

    RECRUITING

    Baggiovara, Modena, Italy

  • San Raffaele Hospital (Ospedale San Raffaele)

    RECRUITING

    Milan, Italy

  • Scientific Practical Medical Center "Innovation and Health"

    RECRUITING

    Novosibirsk, Russia

  • Skåne University Hospital

    RECRUITING

    Malmö, Sweden

  • Tel-Aviv Medical Center Hôpital Sourasky (ICHILOV)

    RECRUITING

    Tel Aviv, Israel

  • The State Institution of Neurology, Psychiatry and Narcology of NAMS of Ukraine

    RECRUITING

    Kharkiv, Ukraine

  • University General Hospital of Larissa

    RECRUITING

    Larissa, Greece

  • University Hospital Leuven (UZ Leuven)

    RECRUITING

    Leuven, Belgium

  • University Hospital Maggiore della Carita

    RECRUITING

    Novara, Italy

  • University Hospital in Turin (Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino)

    RECRUITING

    Torino, Italy

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of Kentucky

    RECRUITING

    Lexington, Kentucky, 40506, United States

  • University of Southern California

    RECRUITING

    Los Angeles, California, 90007, United States

  • University of Virginia Health System

    RECRUITING

    Charlottesville, Virginia, 22903, United States

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