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Phase 3 Study to Compare the Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients

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ClinicalTrials.gov Identifier: NCT03127267
Recruitment Status : Not yet recruiting
First Posted : April 25, 2017
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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).

Condition or disease Intervention/treatment Phase
ALS Drug: Masitinib Mesylate Drug: Riluzole 50Mg Tablet Drug: Placebo Oral Tablet Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 406 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Groups, 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 Amyotrophic Lateral Sclerosis (ALS)
Anticipated Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : September 1, 2019


Arms and Interventions

Arm Intervention/treatment
Experimental: Masitinib
masitinib in combination with riluzole
Drug: Masitinib Mesylate
treatment per os
Drug: Riluzole 50Mg Tablet
treatment per os
Placebo Comparator: placebo
placebo in combination with riluzole
Drug: Riluzole 50Mg Tablet
treatment per os
Drug: Placebo Oral Tablet
treatment per os


Outcome Measures

Primary Outcome Measures :
  1. Absolute change from baseline to week 48 in Amyotrophic Lateral Sclerosis functional rating scale (ALSFRS)-Revised. [ Time Frame: Week 48 ]
    Revised-ALS Functional Rating Score


Secondary Outcome Measures :
  1. Change in ALSAQ-40 from baseline to week 48 [ Time Frame: Week 48 ]
    ALS quality of life patient questionnaire


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 81 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03127267


Contacts
Contact: Angela Genge (514) 398-3868 angela.genge@mcgill.ca
Contact: Alain Moussy a.moussy@ab-science.com

Sponsors and Collaborators
AB Science
More Information

Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT03127267     History of Changes
Other Study ID Numbers: AB14008
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Motor Neuron Disease
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Riluzole
Anticonvulsants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents