Overview

This trial has been completed.

Condition amyotrophic lateral sclerosis (als)
Treatments masitinib (ab1010), riluzole, placebo
Phase phase 2/phase 3
Sponsor AB Science
Start date April 2013
End date December 2016
Trial size 394 participants
Trial identifier NCT02588677, AB10015

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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
Masking participant, investigator
Arm
(Experimental)
masitinib (ab1010)
4.5 mg/kg/day, 3 mg/kg/day
riluzole
(Experimental)
masitinib (ab1010)
4.5 mg/kg/day, 3 mg/kg/day
riluzole
(Placebo Comparator)
riluzole
placebo

Primary Outcomes

Measure
Change in Amyotrophic Lateral Sclerosis functional rating scale (ALSFRS)-Revised
time frame: from baseline to week 48

Secondary Outcomes

Measure
Change of Forced Vital Capacity (FVC)
time frame: from baseline to each time point (week 4, 8, 12, 24, 36, 48)
Combined Assessment of Function and Survival (CAFS)
time frame: from baseline to week 48
Quality of Life
time frame: from baseline to week 48

Eligibility Criteria

All participants at least 18 years old.

Inclusion Criteria: Main inclusion criteria: 1. Familial or sporadic ALS 2. Patient diagnosed with laboratory supported, clinically probable of definite ALS 3. Patient treated with a stable dose of riluzole (100 mg/day) for at least 30 days prior to screening Exclusion Criteria: 1. Patient who underwent tracheostomy and/or gastrostomy

Additional Information

Official title Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Group, Phase 2/3 Study to Compare the Efficacy and Safety of Masitinib
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2017.
Information provided to ClinicalTrials.gov by AB Science.