Neuroprotection With Riluzole Patients With Early Multiple Sclerosis
Status:
Completed
Trial end date:
2012-10-01
Target enrollment:
Participant gender:
Summary
This is a double blind, randomized, parallel group design placebo-controlled mono-center
study. Patients will be evaluated within twelve months of CIS onset. Patients with at least 2
silent ovoid T2 bright areas in the deep white matter on their clinic brain MRI scan will be
offered participation in the study. Patients will be randomized to oral riluzole or placebo
(1:1). Patient will take 50 mg of riluzole or placebo once a day for one month. If 50 mg once
a day is well tolerated, patients will then go on 50 mg twice daily for the rest of the
study. They will start Avonex (Interferon beta 1a) therapy 30 mcg IM once weekly 3 months
after study drug (riluzole or placebo) is initiated if their liver function has remained
normal.
Forty patients within twelve months of onset CIS onset will be enrolled at UCSF MS Center.
Patients will be evaluated every month for the first 12 months and every three months
thereafter for a total study duration of 24-month. Enrollment period will last six months.
Phase:
Phase 2
Details
Lead Sponsor:
University of California, San Francisco
Collaborators:
National Multiple Sclerosis Society Oregon Health and Science University