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

Phase 3 Recruiting 495 enrolled AB Science

RandomizedParallel-groupDouble-blindTreatment

Summary

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).

Timeline

Start: 2021-02-02
Primary completion: 2027-12
Completion: 2027-12

Publications

Latham BD, Oskin DS, Crouch RD, Vergne MJ, Jackson KD. Cytochromes P450 2C8 and 3A Catalyze the Metabolic Activation of the Tyrosine Kinase Inhibitor Masitinib. Chem Res Toxicol. 2022 Sep 19;35(9):1467-1481. doi: 10.1021/acs.chemrestox.2c00057. Epub 2022 Sep 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Masitinib	Small molecule	4.5 mg/kg	Oral
Subject	Masitinib	Small molecule	6 mg/kg	Oral
Background	Riluzole	Small molecule	50 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications