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NCT00501943 · ClinicalTrials.gov registry record · Phase 2
Neuroprotection With Riluzole Patients With Early Multiple Sclerosis
A Phase 2 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT00501943 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 43 participants.
The verdict
NCT00501943, a Phase 2 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Riluzole
- DRUG Avonex (Interferon beta 1a)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2006-07 |
| Est. Completion | 2012-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00501943
The ClinicalTrials.gov registry entry for NCT00501943 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00501943 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00501943 about?
NCT00501943 is a clinical study titled "Neuroprotection With Riluzole Patients With Early Multiple Sclerosis". 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...
What is the current status of trial NCT00501943?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2006-07. Estimated completion is 2012-10.
What interventions are being tested in trial NCT00501943?
The interventions under investigation include: Placebo (DRUG), Riluzole (DRUG), Avonex (Interferon beta 1a) (DRUG).
Who is sponsoring clinical trial NCT00501943?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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