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

We conducted an 18-month, placebo-controlled, double-blind study to evaluat e cladribine in the treatment of 52 patients with relapsing-remitting multi ple sclerosis. Patients received either placebo or cladribine 0.07 mg/ kg/d ay 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 st atistically significant favorable effect of cladribine on the joint frequen cy and severity of relapses and magnetic resonance imaging (MRT) findings. MRI-enhancing lesions were completely suppressed in the cladribine patients by the sixth month of treatment. Mild segmental herpes tester occurred in two cladribine-treated patients and one patient receiving placebo. Otherwis e, there were no side effects or adverse events. We conclude that cladribin e shows promise as a treatment for relapsing-remitting multiple sclerosis.