Safety and Efficacy of Pravastatin in Relapsing-remitting Multiple Sclerosis

Nantes University Hospital (NUH)

Status and phase

Completed

Phase 3

Conditions

Relapsing-remitting Multiple Sclerosis

Treatments

Drug: Pravastatin

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00200655

BRD/03/10-I-1

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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