Safety and Efficacy of Pravastatin in Relapsing-remitting Multiple Sclerosis

Phase 3

Completed

• Conditions: Relapsing-remitting Multiple Sclerosis

• Registration Number: NCT00200655
• Lead Sponsor: Nantes University Hospital

Brief Summary

Therapeutic strategies for multiple sclerosis (MS) are essentially based on the use of immunomodulatory agents such as interferon b and glatirmere acetate, but their efficacy is quite limited, they are not well tolerated and they have a very high cost. Recent works showed an immunomodulatory effects of HMG-CoA reductase inhibitors (the so-called "statins"). In experimental allergic encephalopathy, a murine model of MS, statins inhibit the onset and progression of the disease through a shift from Th1 towards Th2 cytokine production. Other in vitro studies suggest the ability of statins to inhibit the lymphocyte migration through the blood brain barrier. Furthermore, in an open labeled human study in MS, statin regimen was associated with a decreased lesional activity assessed by MRI. Statins are well tolerated drugs, used for many years, with a low cost and with a putative efficacy in MS. The investigators suggest to test the pravastatin safety and efficacy on MRI criteria in a double-blind, placebo-controlled study in 40 patients with a relapsing-remitting MS.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Study Completion: 2007-11
• Status Verified: 2008-06
• Last Update Submitted: 2016-04-27
• Last Update Posted: 2016-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Relapsing remitting MS with diagnosis defined by the McDonald criteria (McDonald et al., 2001) with no current disease modifying therapy (interferon, copaxone or immunosuppressant drugs) since at least 3 months and an EDSS score < 5.
• At least one gadolinium positive lesion on the MRI of the selection phase is needed.
• No current statin therapy.
• Normal renal and hepatic biological tests.
• No current pregnancy

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of gadolinium positive lesions at month 6 in each group.	at month 6 in each group

Secondary Outcome Measures

Name	Time	Method
Cumulated number of gadolinium positive lesions in each group after 6 months of follow-up	after 6 months of follow-up
Number of new T2 lesions

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France