A Biomarker Study to Evaluate MN-166 (Ibudilast) in Subjects With Amyotrophic Literal Sclerosis (ALS)
Status:
Completed
Trial end date:
2020-06-30
Target enrollment:
Participant gender:
Summary
This is a multi-center, open-label study of MN-166 (ibudilast) in subjects with ALS. To be
eligible subjects must meet the El Escorial criteria of possible, laboratory-supported
probable, probable, or definite criteria for a diagnosis of ALS. Safety, tolerability, blood,
neuro-imaging biomarkers, and clinical outcomes will be collected on all subjects. Subjects
will receive study drug for 36 weeks.
The study will consist of a Screening Phase (up to 6 weeks), an Open-Label Treatment Phase
(36 weeks) and a Off-Treatment Follow-up Phase (4 Weeks).
Number of Subjects (Planned):
Approximately 45 subjects are planned to be screened with the goal of enrolling 35 subjects.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
MediciNova
Collaborators:
Massachusetts General Hospital South Shore Neurologic Associates