Tests masitinib with riluzole in people with ALS
Tests masitinib added to riluzole, compared with placebo, in adults with ALS.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients
Key facts
- Where
- Angers, Bordeaux, Bron, Clermont-Ferrand, Lille, Limoges, Marseille, Montpellier, Nancy, Nice, and Tours, FranceSee the 11 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with ALS who already take riluzole and whose disease is getting worse at a steady pace. It tests masitinib with riluzole against placebo with riluzole.
- Age
- 18 to 81 years
- Sex
- Men and women
- Disease stage
- Probable or definite ALS (family or sporadic form), diagnosed no more than 24 months before screening, with an ALSFRS-R score of at least 26 overall at screening and a steady fall in the ALSFRS-R score.
- Earlier treatment
- Must have taken a stable dose of riluzole (100 mg/day) for at least 12 weeks before the baseline visit.
Main reasons for not taking part
- Dementia, or a serious neurological, psychiatric, systemic or organ disease that is uncontrolled or could affect the trial
- FVC below 60% of the expected value at screening and baseline
- Pregnant or nursing women
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 81 years old?
Source: NCT03127267, who can take part
Where in France
- CHU de AngersAngers, FranceTaking people
- Groupe Hospitalier Pellegrin TripodeBordeaux, FranceTaking people
- Hôpital Neurologique Pierre WertheimerBron, FranceTaking people
- Chu Gabriel MontpiedClermont-Ferrand, FranceTaking people
- CHU De Lille, Hôpital Roger SalengroLille, FranceTaking people
- CHU de Limoges-Hopital DupuytrenLimoges, FranceTaking people
- CHU de Marseille - Hôpital de la TimoneMarseille, FranceTaking people
- CHRU de Montpellier - Gui de ChauliacMontpellier, FranceTaking people
- CHU de Nancy -Hôpital CentralNancy, FranceTaking people
- CHU Hôpital Pasteur NiceNice, FranceTaking people
- CHRU de Tours- Hopital BretonneauTours, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AB Science
- Trial code
- NCT03127267
- Record updated
- 12 September 2025
- Original description
The objective is to compare the efficacy and safety of masitinib in combination with riluzole versus matched placebo in combination with riluzole for the treatment of Amyotrophic Lateral Sclerosis (ALS).Read full original descriptionShow less
Phase 3 Study to Compare the Efficacy and Safety of Masitinib in Combination With Riluzole Versus Placebo in Combination With Riluzole in the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)
The objective is to compare the efficacy and safety of masitinib in combination with riluzole versus matched placebo in combination with riluzole for the treatment of Amyotrophic Lateral Sclerosis (ALS).
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.