Overview

Atorvastatin in Relapsing-Remitting Multiple Sclerosis

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Charite University, Berlin, Germany
Collaborators:
German Federal Ministry of Education and Research
German Research Foundation
Pfizer
Treatments:
Atorvastatin
Atorvastatin Calcium
Interferon-beta
Interferons