Efficacy and Safety of Masitinib in Combination With SoC Versus Placebo in the Treatment of ALS Patients

Inclusion Criteria

• •1. The patient must have been diagnosed with clinically probable or definite ALS based on the World Federation of Neurology Revised El Escorial criteria.
• •2. Patients aged 18 to 80 years old and who have either familial or sporadic ALS.
• •3. Patients must have been treated with a stable dose of Riluzole (100 mg/day) for at least 30 days before the entering the trial.
• •4. If they are taking it, patients must have been on a stable dose for at least 30 days before study entry;
• •5. Patients should have experienced the first symptom of ALS no longer than 36 months before the screening visit
• •6. Disease Progression Rate: The ALSFRS-R progression rate (measured between onset and screening) should be between 0.3 and 1.1 point/month
• •7. 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
• •8. 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