Ibudilast (MN-166) in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Status:
Completed
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
Summary
This is a single center, randomized, double-blind, placebo-controlled, 6-month study designed
to evaluate the safety, tolerability and clinical responsiveness of MN-166/ibudilast (60
mg/day) when administered as an adjunct to riluzole (100 mg/day) in 60 subjects with ALS.
This study will consist of two treatment arms, MN-166 and matching placebo. Randomization
will occur in a 2:1 ratio (MN- 166: placebo).
Duration of Treatment: Screening Phase: up to 3 months; Double-blind Phase: 6 months;
Open-label Phase 6 months (for placebo subjects only); Follow-up Phase: 2 weeks after last
dose.
During treatment phase, subjects return to the clinic at Months 3 and 6 and will be
telephoned by staff at Months 1,2,4, and 5 to collect information about side effects and new
or concomitant medications.
All subjects (subjects who complete the Double-blind Phase and subjects who complete the
Open-label Phase) or prematurely discontinue will return for a follow-up visit approximately
2 weeks after the last dose of study drug to assess adverse event status and to document
concomitant medications.
Safety will be assessed by monitoring and recording all treatment-emergent adverse events
(TEAEs) including serious adverse events (SAEs) and discontinuations due to TEAEs. Additional
assessments will include regular monitoring of hematology, blood chemistry, and urine values,
regular measurement of vital signs, ECGs, medical history, physical and neurological
examinations.