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  • Title: A double-blind, placebo-controlled, randomized trial of cladribine in relapsing-remitting multiple sclerosis.
    Author: Romine JS, Sipe JC, Koziol JA, Zyroff J, Beutler E.
    Journal: Proc Assoc Am Physicians; 1999; 111(1):35-44. PubMed ID: 9893155.
    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.
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