A Double‐Blind, Placebo‐Controlled, Randomized Trial of Cladribine in Relpaasing‐Remitting Multiple Sclerosis
- 1 January 1999
- journal article
- clinical trial
- Published by Wiley in Proceedings of the Association of American Physicians
- Vol. 111 (1) , 35-44
- https://doi.org/10.1046/j.1525-1381.1999.09115.x
Abstract
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.Keywords
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