A Phase 3 Study to Compare the Efficacy and Safety of Masitinib in Combination With Riluzole Versus Placebo in Combination With Riluzole in the Treatment of Patients Suffering From ALS

Study Purpose:

The objective is to compare the efficacy and safety of masitinib in combination with riluzole versus corresponding placebo in combination with riluzole in the treatment of patients diagnosed with Amyotrophic Lateral Sclerosis (ALS).

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Not yet enrolling

Phase:

Phase III

Study Chair(s)/Principal Investigator(s):

Clinicaltrials.gov ID (11 digit #):

NCT03127267

Neals Affiliated?

No

Coordinating Center Contact Information

McGill University
Angela Genge / .(JavaScript must be enabled to view this email address) / 514-398-3868
Alain Moussy / .(JavaScript must be enabled to view this email address) Canada

Full Study Summary:

Study Sponsor:

AB Science

Participant Duration:

Estimated Enrollment:

406

Estimated Study Start Date:

09/01/2017

Estimated Study Completion Date:

09/01/2019

Posting Last Modified Date:

11/08/2017

Date Study Added to alsconsortium.org:

11/08/2017
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    81

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    Inclusion Criteria:

    Patient diagnosed with laboratory supported, clinically probable or definite ALS
    Patient treated with a stable dose of riluzole (100 mg/day) for at least 30 days prior to screening
    Patient with adequate organ function at screening

    Exclusion Criteria:

    Patient who underwent tracheostomy and /or gastrostomy

  • Site Contact Information