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Taking people in United StatesPhase 3

Tests masitinib with riluzole in people with ALS

Tests masitinib added to riluzole, compared with placebo, in adults with ALS.

Key facts

Who runs it
AB Science
Where
Baltimore, Birmingham, Burlington, Charlottesville, Lexington, and Los Angeles, United StatesSee the 6 sitesAlso in 16 other countries, 50 sites
Trial code
Registry title
Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients
Status
Recruiting
Phase
Phase 3
People taking part
495 people, planned
Started
2 Feb 2021
Expected to end
Dec 2027
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Masitinib (6.0)
  • Riluzole
  • Placebo
  • Masitinib (4.5)
Record updated
12 September 2025

Who can take part

AI summary

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

The registry criteria, word for word

Show all 10 criteriaShow less

Other criteria

  • 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

Check if you might fit

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 United States

Also in 16 other countries, 50 sites

  • Johns Hopkins Medicine Brain Science InstituteBaltimore, United StatesContact: Clinical Study CoordinatorTaking people
  • University of Alabama at BirminghamBirmingham, United StatesContact: Clinical Study CoordinatorTaking people
  • Lahey Hospital and Medical CenterBurlington, United StatesContact: Clinical Study CoordinatorTaking people
  • University of Virginia Health SystemCharlottesville, United StatesContact: Clinical Study CoordinatorTaking people
  • University of KentuckyLexington, United StatesContact: Clinical Study CoordinatorTaking people
  • University of Southern CaliforniaLos Angeles, United StatesContact: Clinical Study CoordinatorTaking people

About the trial

What the trial wants to find out

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).

The 3 groups in the trial

  • Masitinib (4.5) & RiluzoleTreatment being tested

    Participants receive masitinib (3.0 mg/kg/day), given orally twice daily, with a dose escalation to 4.5 mg/kg/day after 4 weeks of treatment. Each ascending dose titration is subjected to a safety control. Masitinib will be administered as an add-on to riluzole at 50 mg b.i.d

    Treatment: Riluzole and Masitinib (4.5)

  • Masitinib (6.0) & RiluzoleTreatment being tested

    Participants receive masitinib (3.0 mg/kg/day), given orally twice daily, with a dose escalation to 4.5 mg/kg/day after 4 weeks of treatment, followed by dose escalation to 6.0 mg/kg/day after 4 weeks of treatment. Each ascending dose titration is subjected to a safety control. Masitinib will be administered as an add-on to riluzole at 50 mg b.i.d.

    Treatment: Masitinib (6.0) and Riluzole

  • Placebo & RiluzolePlacebo, for comparison

    Participants receive a matched dose placebo, given orally twice daily, in combination with riluzole at 50 mg b.i.d.

    Treatment: Riluzole and Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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)
Plain-language title
Tests masitinib with riluzole in people with ALSGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT03127267, who can take part
Record updated
12 September 2025