Masitinib added to riluzole versus placebo for people with ALS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Masitinib is an oral selective tyrosine kinase inhibitor that targets mast cells and microglia to reduce neuroinflammation, with supportive neuroprotective findings in preclinical work. This multicenter, double-blind, randomized, placebo-controlled phase 3 study compares two ascending dose regimens of oral masitinib plus standard riluzole against matching placebo plus riluzole. Eligible participants must have probable or definite ALS within 24 months of diagnosis, be on a stable riluzole dose, and show recent functional decline on the ALSFRS-R prior to randomization. The trial tracks functional outcomes and safety measures to determine whether masitinib provides additional clinical benefit over riluzole alone.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• University of Southern California
  Los Angeles, California, United States Recruiting
• University of Kentucky
  Lexington, Kentucky, United States Recruiting
• Johns Hopkins Medicine Brain Science Institute
  Baltimore, Maryland, United States Recruiting
• Lahey Hospital and Medical Center
  Burlington, Massachusetts, United States Recruiting
• University of Virginia Health System
  Charlottesville, Virginia, United States Recruiting

+6 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Albert Ludolph, MD, PhD — Department of Neurology, University of Ulm, Germany
• Study coordinator: Clinical Study Coordinator
• Email: clinical@ab-science.com
• Phone: +33(0)147200014

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.