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โ† Trials
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Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients

RecruitingPhase 3Ages 18 Years - 81 YearsAllAB Science
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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
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What it tests

  • Masitinib (6.0)
  • Riluzole
  • Placebo
  • Masitinib (4.5)
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Where

56 sites
University of Alabama at Birmingham
Birmingham, United States
University of Southern California
Los Angeles, United States
University of Kentucky
Lexington, United States
Johns Hopkins Medicine Brain Science Institute
Baltimore, United States
Lahey Hospital and Medical Center
Burlington, United States
University of Virginia Health System
Charlottesville, United States
University Hospital Leuven (UZ Leuven)
Leuven, Belgium
Bispebjerg Hospital
Copenhagen, Denmark

โ€ฆand 48 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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