Oral Cladribine in Early Multiple Sclerosis (MS) (ORACLE MS)
Posted Nov 17 2009 10:20pm
This study is currently recruiting participants.
Verified by EMD Serono, March 2009
A randomized, double-blind, clinical trial to assess the safety and efficacy of two doses of oral cladribine vs. placebo in subjects who had a first clinical demyelinating event (clinically isolated syndrome). Subjects in either the cladribine or placebo group may also enter treatment periods with open-label interferon-beta or open-label cladribine depending upon the disease status. The primary objective of this study is to evaluate the effect of 2 dosage regimens of oral cladribine vs. placebo on the time to conversion to Multiple Sclerosis (MS) (from randomization) according to the revised McDonald criteria in subjects with a first clinical demyelinating event at high risk of converting to MS.