A double-blind, placebo-controlled, randomized trial of cladribine in relapsing-remitting multiple sclerosis.

Author(s): Romine JS, Sipe JC, Koziol JA, Zyroff J, Beutler E

Affiliation(s): Division of Neurology, Scripps Clinic, La Jolla, CA 92037, USA.

Publication date & source: 1999-01, Proc Assoc Am Physicians., 111(1):35-44.

Publication type: Clinical Trial; Randomized Controlled Trial

We conducted an 18-month, placebo-controlled, double-blind study to evaluate cladribine in the treatment of 52 patients with relapsing-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 relapses 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 relapsing-remitting multiple sclerosis.