Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AB Science
Study ID
NCT03127267
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 81 Years
Healthy Volunteers
Not accepted

Interventions

  • Masitinib (6.0) — DRUG
    Masitinib (titration to 6.0 mg/kg/day)
  • Riluzole — DRUG
    Riluzole 50 mg tablet, treatment per os
  • Placebo — DRUG
    treatment per os
  • Masitinib (4.5) — DRUG
    Masitinib (titration to 4.5 mg/kg/day)

Study Details

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

Key Dates

Start date
Feb 2, 2021
Status verified
Sep 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
495 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Masitinib (4.5) & Riluzole
    Participants receive masitinib (3.0 mg/kg/day), given orally twice daily, with a dose escalation to 4.5 mg/kg/day after 4 weeks of treatment. Each ascending dose titration is subjected to a safety control. Masitinib will be administered as an add-on to riluzole at 50 mg b.i.d
  • Experimental: Masitinib (6.0) & Riluzole
    Participants receive masitinib (3.0 mg/kg/day), given orally twice daily, with a dose escalation to 4.5 mg/kg/day after 4 weeks of treatment, followed by dose escalation to 6.0 mg/kg/day after 4 weeks of treatment. Each ascending dose titration is subjected to a safety control. Masitinib will be administered as an add-on to riluzole at 50 mg b.i.d.
  • Placebo Comparator: Placebo & Riluzole
    Participants receive a matched dose placebo, given orally twice daily, in combination with riluzole at 50 mg b.i.d.

Primary Outcome Measure

ALSFRS-R [ Time Frame: 48 weeks ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
University of Southern CaliforniaLos AngelesCalifornia90007-
University of KentuckyLexingtonKentucky40506-
Johns Hopkins Medicine Brain Science InstituteBaltimoreMaryland21205-
Lahey Hospital and Medical CenterBurlingtonMassachusetts01805-
University of Virginia Health SystemCharlottesvilleVirginia22903-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALUniversity of Southern California· Los Angeles, CAUniversity of Kentucky· Lexington, KYJohns Hopkins Medicine Brain Science Institute· Baltimore, MDLahey Hospital and Medical Center· Burlington, MAUniversity of Virginia Health System· Charlottesville, VA

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