A Double-Blind, Placebo-Controlled, Randomized Trial of Cladribine in Relpaasing-Remitting Multiple Sclerosis


John S. Romine M.D. , Division of Neurology, MS313, Scripps Clinic, 10666 North Torrey Pines Road, La Jolla, CA 92037.


We conducted an 18-month, placebo-controlled, double-blind study to evaluate cladribine in the treatment of 52 patients with relpaasing-remitting multiple sclerosis. Patients received either placebo or cladribine 0.07 mg/kg/day by subcutaneous injection for 5 consecutive days as six monthly courses for a total cumulative dose of 2.1 mg/kg. Analysis of results revealed a statistically significant favorable effect of cladribine on the joint frequency and severity of relpaases and magnetic resonance imaging (MRI) findings. MRI-enhancing lesions were completely suppressed in the cladribine patients by the sixth month of treatment. Mild segmental herpes zoster occurred in two cladribine-treated patients and one patient receiving placebo. Otherwise, there were no side effects or adverse events. We conclude that cladribine shows promise as a treatment for relpaasing-remitting multiple sclerosis.