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

PHASE3Not yet recruitingINTERVENTIONAL

Enrollment

412

Participants

Timeline

Start Date

January 1, 2026

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2029

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Interventions

DRUG

Masitinib 4.5 mg/kg/day

Masitinib (titration to 4.5 mg/kg/day)

DRUG

Placebo

treatment per os

DRUG

Riluzole (100 mg)

Riluzole 50 mg tablet, treatment per os

Trial Locations (1)

Aiginition Hospital, Athens