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

NCT ID NCT03127267

Recruiting now Disease control Sponsor: AB Science Source: ClinicalTrials.gov ↗

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.

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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

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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