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Masitinib in Combination With Riluzole for the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)

Amyotrophic Lateral Sclerosis (ALS) Clinical Trial

Official title:
Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Group, Phase 2/3 Study to Compare the Efficacy and Safety of Masitinib

Clinical Trial Summary

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).

Clinical Trial Description

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. There are two distinct populations of ALS patients: population of "Normal progressors" and population of "Faster progressors". Targeted population for primary analysis is population of "Normal progressors". "Normal progressors" are ALS patients whose progression of ALSFRS-R score before randomization is less than 1.1 point per month. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02588677
Study type Interventional
Source AB Science
Contact
Status Completed
Phase Phase 2/Phase 3
Start date April 2013
Completion date March 2018
View Details
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