Safety and Efficacy of Pravastatin in Relapsing-remitting Multiple Sclerosis
Status:
Completed
Trial end date:
2007-11-01
Target enrollment:
Participant gender:
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.