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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: Completed Phase 2 study, sponsored by University of California, San Francisco.
NCT00501943 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Baseline MRI is compared to MRI images collected during subsequent timepoints. The percent brain volume change is measured using SIENAX (Structural Image Evaluation using Normalization of Atrophy-X)
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 |
What the finished NCT00501943 record still lists
NCT00501943 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00501943 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00501943's enrollment target sits among peer trials
43 1332nd of 2000 higher than 662 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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