Testing masitinib added to usual care for amyotrophic lateral sclerosis
Tests masitinib with usual care against placebo in adults with ALS.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Masitinib in Combination With SoC Versus Placebo in the Treatment of ALS Patients
Key facts
- Where
- Bonn, Göttingen, Jena, Leipzig, and München, GermanySee the 5 sites
- 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 80 years old?
Source: NCT07174492, who can take part
Where in Germany
- Universitaetsklinikum Bonn AöRBonn, GermanyNo longer taking part
- University Clinic Of GoettingenGöttingen, GermanyNo longer taking part
- University Hospital JenaJena, GermanyNo longer taking part
- Universitaet LeipzigLeipzig, GermanyNo longer taking part
- Klinikum rechts der Isar der Technischen Universität MünchenMünchen, GermanyNo longer taking part
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
- NCT07174492EU 2024-511244-12-01
- Record updated
- 3 October 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
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)
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).
Inclusion: 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.
Exclusion: 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.