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Atorvastatin in Relapsing-Remitting Multiple Sclerosis

Relapsing Remitting Multiple Sclerosis Clinical Trial

Official title:
Oral High-Dose Atorvastatin Treatment in Relapsing-Remitting Multiple Sclerosis

Clinical Trial Summary

A phase II open-label baseline-to-treatment trial was designed to evaluate the safety, tolerability and efficacy of orally administered atorvastatin in patients with relapsing-remitting multiple sclerosis (RRMS). Patients with at least one gadolinium-enhancing lesion (CEL) at screening by magnetic resonance imaging (MRI) were eligible for the study. Patients are screened and enrolled in the outpatient clinic of the Cecilie Vogt Clinic at the Charité - University Medicine Berlin. After a baseline period of 3 monthly MRI scans (months -2 to 0), patients followed a 9-month treatment period on 80 mg atorvastatin daily. The primary endpoint is the number of CEL in treatment months 6 to 9 compared to baseline. Secondary endpoints include other MRI-based parameters and changes in clinical scores and immune responses.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00616187
Study type Interventional
Source Charite University, Berlin, Germany
Contact
Status Completed
Phase Phase 2
Start date October 2003
View Details
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