Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients
Key facts
- Where
- Ulm, GermanySee the site
- Phase
- Phase 3
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?
Where in Germany
- Department of Neurology, University of UlmUlm, GermanyNot yet recruiting
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.