Official Title: “Safety and Efficacy of Pravastatin in Relapsing-Remitting MS: a Double Blind Placebo Controlled Study”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Pravastatin
• Drug: Placebo

Primary Measures

• Number of gadolinium positive lesions at month 6 in each group.
  • Time Frame: at month 6 in each group
    

Secondary Measures

• Cumulated number of gadolinium positive lesions in each group after 6 months of follow-up
  • Time Frame: after 6 months of follow-up
    
• Number of new T2 lesions

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Nantes University Hospital

Overall Clinical Trial Officials and Contacts

Philippe DAMIER, MD Principal Investigator Nantes UH  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00200655

Study ID Number: BRD/03/10-I

ClinicalTrials.gov Identifier: NCT00200655

Health Authority: France: Afssaps - French Health Products Safety Agency