Neuroprotection With Riluzole Patients With Early Multiple Sclerosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT00501943

Run by

University of California, San Francisco

People needed

43

Starts

2006-07-01

Expected to finish

2012-10-01

Last updated by the study team

2014-04-09

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient must give written informed consent;
• Patients with a early MS or clinically isolated syndromes (CIS) in the past 12 months as defined by an acute or sub-acute episode suggestive of demyelination affecting the optic nerves, brain stem or spinal cord or other central nervous system location.
• Entry age 18-55
• Males and females
• At least 2 silent T2 bright areas in the deep white matter on screening brain MRI.
• No riluzole, interferon, copaxone, cyclophosphamide, mitoxantrone or other off-label immunosuppressive drugs for MS prior to study entry
• No corticosteroid during the 4 weeks prior to baseline MRI exam
• No prior exposure to total lymphoid irradiation
• No history of substance abuse, including documented alcohol dependence within 6 months prior to screening or alcohol liver damage with AST , ALT > twice upper normal limits
• No pregnant or nursing patients
• No history of systemic illness or medical condition that would limit the likelihood of completing the gadolinium-enhanced MRI procedures. Automatic exclusionary conditions will include hypersensitivity reaction to riluzole or any of the tablets components, uncontrolled hypertension, epilepsy, and insulin dependent diabetes, asthma, known malignancy other than skin cancer, symptomatic cardiac disease or metallic objects on or inside the body.
• Patients willing to use birth control during the study.
• Patients willing to go on Avonex therapy 3 months after being randomized to study drug and no contra-indication to use of interferon therapy.

You may not qualify if…

• A history of major depression or psychosis.
• A clinically significant MS exacerbation within 30 days of the screening
• Pregnancy
• Abnormal screening liver function (AST or ALT > twice the upper normal limit).
• Patients receiving hepatotoxic medications such as drugs interfering with CYP 1A2.

Where it is running

• UCSF MS Center , 675 Nelson Rising Lane, Suite 221 — San Francisco, California, United States

Full record on ClinicalTrials.gov

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