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Phase IV Double-Blind Randomized Study to Evaluate Safety and Efficacy of Interferon Beta-1a (Avonex) Plus Simvastatin (Zocor) Combination Therapy in Clinically Isolated Syndrome Suggestive of Multiple Sclerosis Over a One Year Period
The purpose of this study is to determine the safety, tolerability and efficacy of a combination therapy interferon beta-1a(Avonex) plus simvastatin (Zocor) vs. interferon beta-1a plus placebo in patients with clinically isolated syndrome suggestive of Multiple Sclerosis.
Details
| Lead sponsor | University of North Carolina |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 30 |
| Start date | 2004-09 |
| Completion | 2007-12 |
Conditions
- Multiple Sclerosis
Interventions
- Avonex/Zocor
Primary outcomes
- The primary objective of this study is to determine whether combination therapy with IFNb-1a plus simvastatin, when compared to IFNb-1a plus placebo decreases or delays additional clinical or MRI activity.
- We will use the following outcome measures:
- Relapse rates, Time to first relapse,Number of new T2 lesions, Number of new Gd-enhancing lesions
Countries
United States