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| Sponsor: | University of California, San Francisco |
|---|---|
| Collaborators: |
National Multiple Sclerosis Society Oregon Health and Science University |
| Information provided by: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00501943 |
Purpose
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 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: Riluzole/Placebo +Avonex |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Riluzole
|
Drug: Riluzole/Placebo +Avonex
Riluzole/Placebo +Avonex
Other Name: Riluzole/Placebo +Avonex
|
|
Placebo Comparator: 2
placebo
|
Drug: Riluzole/Placebo +Avonex
Riluzole/Placebo +Avonex
Other Name: Riluzole/Placebo +Avonex
|
To determine the effect of riluzole up to 50 mg bid on MRI parameters, including T1 lesions load, atrophy of gray and white matter, and 1H-MRSI; and to determine safety of riluzole when administered orally up to 50 mg bid for 2 years in double blinded clinical trial of patients with clinically isolated syndromes (CIS) and at least 2 silent T2-bright areas in the deep white matter. These patients have a high risk of conversion to MS within 2 years and faster rate of atrophy (Dalton 2004).
Specific aims:
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| UCSF MS Center , 350 Parnassus Ave , suite #908 | |
| San Francisco, California, United States, 94117 | |
| Principal Investigator: | Emmanuelle Waubant, MD, PhD | UCSF , MS Center |
| Principal Investigator: | Emmanuelle Waubant, MD PhD | UCSF, MS Center |
More Information
| Responsible Party: | University of California, San Francisco, MS Center |
| ClinicalTrials.gov Identifier: | NCT00501943 History of Changes |
| Other Study ID Numbers: | H9924-29155-05 |
| Study First Received: | July 12, 2007 |
| Last Updated: | April 2, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes Riluzole Interferon beta 1a Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Neuroprotective Agents Protective Agents Central Nervous System Agents Therapeutic Uses Anticonvulsants Adjuvants, Immunologic Immunologic Factors Antineoplastic Agents |