Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Group, Phase 2/3 Study to Compare the Efficacy and Safety of Masitinib
The objective is to compare the efficacy and safety of masitinib in combination with riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS).
Disease:Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALS
Study Type:Interventional Trial
Study Category:Drug Trial
Study Chair(s)/Principal Investigator(s):
Clinicaltrials.gov ID (11 digit #):NCT02588677
Coordinating Center Contact Information
Full Study Summary:
Masitinib is novel tyrosine kinase inhibitor that targets microglia and mast cells through inhibiting a limited number of kinases. Masitinib blocks microglia proliferation and activation, and mast cell-mediated degranulation, the release of cytotoxic substances that might further damage the motor nerves.
Primary Outcome Measures:
-Change from baseline to week 48 in Amyotrophic Lateral Sclerosis functional rating scale (ALSFRS)-Revised [ Time Frame: from baseline to week 48 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
-Amyotrophic Lateral Sclerosis functional rating scale (ALSFRS)-Revised [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
-Overall survival (OS) [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
-Forced vital capacity (FVC) [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
-Quality of life [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
-Safety profile [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: Yes ]
Study Sponsor:AB Science
up to 48 weeks
Estimated Study Start Date:03/31/2014
Estimated Study Completion Date:11/30/2016
Posting Last Modified Date:11/30/2015
Date Study Added to alsconsortium.org:11/24/2013
This trial is currently not recruiting in the United States.
Time since Symptom Onset:N/A
Time since Diagnosis:
Can participants use Riluzole?
-Familial or sporadic ALS
-Patient diagnosed with laboratory supported, clinically probable of definite ALS
-Patient treated with a stable dose of riluzole (100 mg/day) for at least 30 days prior to screening
-Patient with history of hematologic, hepatic, respiratory disorder that is clinically significant for his/her participation in the study.
Site Contact Information
Clinique Neuro Rive-Sud
Greenfield Park, Quebec
Hospital Carlos III
Montreal Neurological Institute and Hospital
Stan Cassidy Rehab Center
Fredericton, New Brunswick
University of Calgary