A double-blind trial of systemic leukocyte interferon therapy for multiple sclerosis (MS) was initiated at three centers in California in 1980 and will be concluded within a year of this writing. The first such trial, it was supported by the National Multiple Sclerosis Society (NMSS). This report outlines the form of the trial, explains its rationale, and describes some of the side effects noted to date. It is hoped that this trial will provide evidence of systemic interferon's efficacy in MS and lead to improved designs in future trials of interferon.
RATIONALE
Several lines of investigation suggest that interferon could be therapeutic in MS. Interferon is clearly a very potent antiviral substance of natural origin.1 Numerous direct and indirect studies have linked MS to a viral infection, even though there has been no clear evidence of a virus, either as the initiator of the disease process or as a