This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the effects of atorvastatin to decrease or delay clinical and MRI disease acitivity in patients with clinically isolated syndrome (CIS) and MRI findings suggestive of MS compared with placebo. After a screening phase (up to 90 days), 2/3 of the subjects will receive active drug, and 1/3 will receive placebo, during a 12-month treatment phase. There is a 6-month follow-up phase. Interferon B-1a (Avonex) will be offered on study to any participant once he or she meets the primary endpoint, which is at least 3 new T2 or Gd+ lesions, in any combination, or 1 clinical exacerbation at any time during the 12-month treatment phase compared to the baseline. In addition to the clincal endpoints, the trial will examine various MRI metrics include spectroscopy for neuronal and glial damage, and also, with the help of the Immune Tolerance Network, a significant amount of immunologic data will be evaluated.
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