Multiple Sclerosis, Secondary Progressive Clinical Trial
Official title:
A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Activity of Ibudilast (MN-166) in Subjects With Progressive Multiple Sclerosis
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study
designed to evaluate the safety, tolerability and activity of ibudilast administered twice
daily over a 96 week period in subjects with primary or secondary progressive multiple
sclerosis who are currently untreated with long-term MS disease modifying therapy (DMT) or
who are receiving either glatiramer acetate (GA) or interferon beta-1, any formulation
(IFNβ-1A [Avonex, Rebif] or IFNβ-1B [Betaseron, Extavia]). Study drug or placebo will be
administered to a total of 250 male and female subjects from 21 to 65 years old, inclusive,
in two treatment groups. Randomization of subjects will be stratified by disease status
(primary progressive multiple sclerosis or secondary progressive multiple sclerosis) and
immunomodulating therapy status: current use of immunomodulating therapy or no current use of
immunomodulating therapy.
The study will consist of a screening phase (up to 30 days) followed by a treatment phase (96
weeks) and a follow-up visit (1 month post Week 96 visit). Following the screening phase,
subjects who continue to meet entry criteria will be randomly assigned to 1 of 2 treatment
groups: doses up to ibudilast 100 mg/day or matching-placebo in a 1:1 ratio. Study drug will
be administered twice daily (BID), e.g., ibudilast 50 mg or placebo taken in the morning and
evening).
n/a
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