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

Study Purpose:

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 Status:

Closed

Phase:

Phase III

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

Unknown

Clinicaltrials.gov ID (11 digit #):

NCT02588677

Neals Affiliated?

No

Coordinating Center Contact Information


Jesús S. Mora / .(JavaScript must be enabled to view this email address)
.(JavaScript must be enabled to view this email address) Madrid, United States

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

Participant Duration:

up to 48 weeks

Estimated Enrollment:

381

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
  • More Information

    This trial is currently not recruiting in the United States.
    https://clinicalt...CT02588677&rank=1

  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    75

    Time since Symptom Onset:

    N/A

    Time since Diagnosis:

    Can participants use Riluzole?


    Inclusion Criteria:
    -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

    Exclusion Criteria:
    -Patient with history of hematologic, hepatic, respiratory disorder that is clinically significant for his/her participation in the study.

  • Site Contact Information

    Montreal Neurological Institute and Hospital
    Kristiana Salmon / .(JavaScript must be enabled to view this email address) / 514-398-1779
    Montreal, Quebec
    Canada

    Hospital Carlos III
    Jesas S. Mora / .(JavaScript must be enabled to view this email address) / Madrid,
    Spain

    University of Calgary
    Calgary, Alberta
    Canada

    Clinique Neuro Rive-Sud
    Greenfield Park, Quebec
    Canada

    Stan Cassidy Rehab Center
    Fredericton, New Brunswick
    Canada

    Sunnybrook
    Toronto, Ontario
    Canada