A randomized, double-blind, clinical trial to assess the safety and efficacy of two doses of
oral cladribine versus placebo in participants who had a first clinical demyelinating event
(clinically isolated syndrome). Participants 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 two dosage regimens of oral cladribine versus placebo on the time to conversion to
multiple sclerosis (MS) (from randomization) according to the Poser criteria in participants
with first clinical demyelinating event at high risk of converting to MS.
Phase:
Phase 3
Details
Lead Sponsor:
EMD Serono EMD Serono Research & Development Institute, Inc.