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

Sponsor
AB Science
Study ID
NCT02588677
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Amyotrophic Lateral Sclerosis (ALS)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Apr 30, 2013
Status verified
Sep 2023
Primary completion
Dec 5, 2016
Completion
Mar 31, 2018

Study Design

Enrollment
394 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Masitinib (3.0) & Riluzole
    masitinib 3 mg/kg/day + riluzole
  • Experimental: Masitinib (4.5) & Riluzole
    masitinib 4.5 mg/kg/day (2) + riluzole
  • Placebo Comparator: Placebo & Riluzole
    Matched placebo

Primary Outcome Measure

Change in Amyotrophic Lateral Sclerosis functional rating scale (ALSFRS)-Revised [ Time Frame: From baseline to week 48 ]

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