Efficacy and Safety of Masitinib in the Treatment of Progressive Multiple Sclerosis

Sponsor
AB Science
Study ID
NCT01433497
Phase
PHASE3
Status
Completed

Conditions

  • Multiple Sclerosis, Primary Progressive
  • Multiple Sclerosis, Relapse Free
  • Multiple Sclerosis, Secondary Progressive

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to compare the safety and efficacy of masitinib 6 mg/kg/day versus placebo in the treatment of patients with primary progressive multiple sclerosis or relapse-free secondary progressive multiple sclerosis.

Key Dates

Start date
Aug 31, 2011
Status verified
Apr 2020
Primary completion
Sep 30, 2019
Completion
Feb 29, 2020

Study Design

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

Arms

  • Experimental: Experimental Arm A
    Participants receive masitinib (4.5 mg/kg/day), given orally twice daily.
  • Experimental: Experimental Arm B
    Participants receive masitinib (4.5 mg/kg/day), given orally twice daily, with a dose escalation to 6 mg/kg/day after 3 months of treatment.
  • Placebo Comparator: Placebo Comparator A
    Participants receive placebo given orally twice daily.
  • Placebo Comparator: Placebo Comparator B
    Participants receive placebo, given orally twice daily, with a matched dose escalation after 3 months of treatment.

Primary Outcome Measure

EDSS [ Time Frame: 96 weeks ]

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