Clinical Trial Tests Cholesterol Drug to Minimize Multiple Sclerosis

Yale School of Medicine is participating in the first clinical trial testing atorvastatin to delay or decrease disease in patients who have experienced a first attack of multiple sclerosis (MS).

Statins, of which atorvastatin is one, are a relatively new group of drugs used to lower cholesterol levels. Researchers believe statins may affect the immune system, reducing brain inflammation associated with MS.

Persons eligible to enroll in the trial, which is being conducted at 15 sites nationwide, have experienced a first attack, or clinically isolated syndrome (CIS), lasting at least 48 hours and involving either the optic nerve, spinal cord, brain stem, or cerebellum.

“Because permanent neurologic damage can occur during the CIS stage, researchers are seeking new treatments,” said Jana Preiningerova, M.D., assistant professor in the Department of Neurology. “Currently, interferon is the only approved therapy for CIS patients, but it has reported side effects and is administered through weekly intra-muscular injections. Atorvastatin, if proven to be effective, can be taken orally and has an established tolerance profile, making it an attractive candidate for patients who need long-term treatment.”

The primary objective of the trial is to evaluate the ability of atorvastatin to decrease or delay clinical and MRI-detected disease activity in patients with CIS and MRI findings suggestive of early MS, compared with placebo.

This trial will also examine whether early intervention in patients with CIS may result in a state of immunological tolerance and whether statins have any residual effect after discontinuation.

The trial is being conducted by the Immune Tolerance Network, which is sponsored by the National Institute for Allergy and Infectious Diseases. Sarah Harma is the study coordinator at Yale School of Medicine. Persons interested in participating in the trial can contact her at 203-764-8160 or sarah.harma@yale.edu