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

Last updated: September 27, 2023
Sponsor: AB Science
Overall Status: Completed

Phase

2/3

Condition

Scar Tissue

Neurologic Disorders

Myasthenia Gravis (Chronic Weakness)

Treatment

Masitinib (4.5)

Masitinib (3.0)

Placebo

Clinical Study ID

NCT02588677
AB10015
  • Ages 18-75
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria: Main inclusion criteria:

  1. Familial or sporadic ALS
  2. Patient diagnosed with probable of definite ALS
  3. Patient treated with a stable dose of riluzole (100 mg/day) for at least 30 days priorto screening

Exclusion

Exclusion Criteria:

  1. Patient who underwent tracheostomy and/or gastrostomy

Study Design

Total Participants: 394
Treatment Group(s): 4
Primary Treatment: Masitinib (4.5)
Phase: 2/3
Study Start date:
April 01, 2013
Estimated Completion Date:
March 31, 2018

Study 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.

Connect with a study center

  • Hospital Carlos III

    Madrid, 28029
    Spain

    Site Not Available

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