A CONTROLLED CLINICAL-TRIAL WITH A SPECIFICALLY CONFIGURED RNA DRUG, POLY(I)CENTER-DOT-POLY(C12U), IN CHRONIC FATIGUE SYNDROME

Chronic fatigue syndrome (CFS) is a physically debilitating illness as sociated with immunologic abnormalities, viral reactivation, and impai rment of cognition. In a randomized, multicenter, placebo-controlled, double-blind study of 92 patients meeting the CFS case definition of t he Centers for Disease Control and Prevention, the response of several laboratory and clinical variables to an antiviral and immunomodulator y drug, poly(I) poly(C12U), was determined. Measures of clinical respo nse included Karnofsky performance score, a cognition scale derived fr om a self-administered instrument assessing symptomatology (SCL-90-R), an activities of daily living scale, and exercise treadmill performan ce. After 24 weeks, patients receiving poly(I) poly(C12U) had higher s cores for both global performance and perceived cognition than did pat ients receiving placebo. In particular, patients given poly(I) poly(C1 2U) had increased Karnofsky performance scores (P < .03), exhibited a greater ability to do work during exercise treadmill testing (P = .01) , displayed an enhanced capacity to perform the activities of daily li ving (P < .04), had a reduced cognitive deficit (P = .05), and require d less use of other medications (P < .05).