Not yet taking people in FrancePhase 3
Testing masitinib added to usual care for amyotrophic lateral sclerosis
Tests masitinib with usual care against placebo in adults with ALS.
Key facts
- Who runs it
- AB Science
- Where
- Lille, Limoges, Ljubljana, and Nice, FranceSee the 4 sitesAlso in 5 other countries, 9 sites
- Trial code
- NCT07174492
- EU 2024-511244-12-01
- U1111-1303-6775
- Registry title
- Efficacy and Safety of Masitinib in Combination With SoC Versus Placebo in the Treatment of ALS Patients
- Status
- Not yet recruiting
- Phase
- Phase 3
- People taking part
- 412 people, planned
- Started
- 1 Jan 2026
- Expected to end
- 31 Dec 2029
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Masitinib 4.5 mg/kg/day
- Placebo
- Riluzole (100 mg)
- Record updated
- 3 October 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 probable or definite ALS who already take a stable dose of riluzole. Masitinib or placebo is added to riluzole.
- Age
- 18 to 80 years
- Sex
- All sexes can join.
- Disease stage
- Clinically probable or definite ALS (familial or sporadic). First symptom no more than 36 months before screening. ALSFRS-R progression rate between 0.3 and 1.1 point/month. Minimum scores on the ALSFRS-R items are required.
- Earlier treatment
- Must have taken a stable dose of riluzole (100 mg/day) for at least 30 days before entering. Must not have been treated with masitinib before.
Main reasons for not taking part
- FVC (forced vital capacity) below 70% of the predicted normal value
- Weight under 41 kg (90 lb), or BMI under 18 or over 35 kg/m²
- Pregnant or nursing women
- Conditions that masitinib may make worse, such as severe skin reactions, liver disorders or severe kidney problems
- Hypersensitivity to masitinib excipients or riluzole
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- The patient must have been diagnosed with clinically probable or definite ALS based on the World Federation of Neurology Revised El Escorial criteria
- Patients aged 18 to 80 years old and who have either familial or sporadic ALS
- Patients must have been treated with a stable dose of Riluzole (100 mg/day) for at least 30 days before the entering the trial
- If they are taking it, patients must have been on a stable dose for at least 30 days before study entry
- Patients should have experienced the first symptom of ALS no longer than 36 months before the screening visit
- Disease Progression Rate: The ALSFRS-R progression rate (measured between onset and screening) should be between 0.3 and 1.1 point/month
- ALSFRS-R Total Score: At screening and baseline, patients need to meet the following criteria:; Item #3: At least 3 points. Item #12: At least 2 points. Other Items: At least 1 point on each of the remaining 10 items
- Contraception: Female patients of childbearing potential and male patients must use a highly effective method of contraception during the trial and for a specified period afterwards
Who cannot take part
- Patient treated concomitantly with medications that may interact with masitinib
- Previous treatment with masitinib
- Patients should not have any significant neurological, psychiatric, systemic or organic disease that could interfere with the trial
- Hypersensitivity to masitinib excipients or riluzole
- Patients with pre-existing conditions that may be aggravated with the use of masitinib (severe skin toxicities or reactions, liver disorders, severe renal impairment, viral infections, cancer, severe cardiovascular disease, high risk of heart attack and/or stroke)
- Participants with a significant pulmonary disorder not attributed to ALS or who require treatments that might complicate the evaluation of the effect of ALS on respiratory function
- Lung function: patients with an FVC (forced vital capacity) of less than 70% of the predicted normal value for their gender, height, and age are excluded
- Patients with a weight less than 41 kg and a BMI (body mass index) less than 18 or greater than 35 kg/m² are not eligible
- Pregnant or nursing female patients at screening and baseline are excluded
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 80 years old?
Where in France
Also in 5 other countries, 9 sites
- Hopital Roger Salengro, CHU LilleLille, FranceNo longer taking part
- Chu DupuytrenLimoges, FranceNo longer taking part
- University Medical CentreLjubljana, FranceNo longer taking part
- CHU de Nice - Hôpital Pasteur 2Nice, FranceNo longer taking part
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 2 groups in the trial
- masitinib + 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: Masitinib 4.5 mg/kg/day and Riluzole (100 mg)
- 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: Placebo and Riluzole (100 mg)
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Prospective, Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Groups, Phase 3 Trial to Compare the Efficacy and Safety of Masitinib in Combination With Standard of Care Versus Placebo in Combination With Standard of Care in the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)
- Plain-language title
- Testing masitinib added to usual care for amyotrophic lateral sclerosisGenerated 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 NCT07174492, who can take part
- Record updated
- 3 October 2025