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Masitinib for Amyotrophic Lateral Sclerosis (ALS)

This study is testing if masitinib, a drug that targets certain immune cells, can help people with Amyotrophic Lateral Sclerosis (ALS) when taken with riluzole. Researchers want to see if masitinib is safe and effective compared to a placebo (an inactive substance). You might be able to join if you are 18 to 81 years old, have been diagnosed with ALS within the last 24 months, and are already taking a stable dose of riluzole. The main goal is to see how masitinib affects your ALS symptoms, measured by a scale called ALSFRS-R, after 48 weeks. The study is currently recruiting about 495 participants, but its exact status is unclear.

Study design
This is a multicenter, double-blind, randomized, placebo-controlled study. It will compare two different doses of masitinib with a placebo in about 495 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 48 weeks, indicating participants will be followed for at least this duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03127267

Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients

Recruiting
PHASE3Ages 18–81InterventionalTreatment
AB Science
~495 participants
Updated 2025-09-12 on ClinicalTrials.gov
What's tested:Masitinib (6.0)RiluzolePlaceboMasitinib (4.5)

At a glance

Recruiting sites
55 of 56 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
ALSFRS-R
Measured over 48 weeks

Conditions

Amyotrophic Lateral Sclerosis

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Amyotrophic Lateral Sclerosis

NCT03127267

Where you'd take part

This study runs at 56 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • ASST degli Spedali Civili di Brescia

    Brescia, Italyno site contact published

    Recruiting

  • Athens Naval Hospital

    Athens, Greeceno site contact published

    Recruiting

  • Azienda Ospedale-Università Padova

    Padova, Italyno site contact published

    Recruiting

  • Bispebjerg Hospital

    Copenhagen, Denmarkno site contact published

    Recruiting

  • Centralsjukhuset Karlstad (Central Hospital Karlstad)

    Karlstad, Swedenno site contact published

    Recruiting

  • Centro Clinico NeMO Fondazione Serena Onlus

    Gussago, Italyno site contact published

    Recruiting

  • Centrum Medyczne Neuromed

    Bydgoszcz, Polandno site contact published

    Recruiting

  • CHRU de Montpellier - Gui de Chauliac

    Montpellier, Franceno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Albert Ludolph, MD, PhD · PRINCIPAL_INVESTIGATOR · Department of Neurology, University of Ulm, Germany

Who to contact

Clinical Study Coordinator
[email protected]
+33(0)147200014
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • ALSFRS-R48 weeks

    Change in Amyotrophic Lateral Sclerosis functional rating scale (ALSFRS)-Revised.