A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS (ASCEND in SPMS)

Phase 3b, multicenter, international, randomized, double-blind, placebo-controlled study to assess the efficacy of natalizumab in approximately 856 SPMS subjects who are exhibiting disease progression independent of relapses. Subjects will be randomized to receive either natalizumab 300 mg or placebo intravenously (IV) every 4 weeks (q4wk) for 96 weeks. This study will be conducted in subjects between the ages of 18 and 58, inclusive, with a diagnosis of SPMS for at least 2 years, an EDSS score between 3.0 and 6.5, inclusive, and documented evidence of disease progression independent of clinical relapses over the 1 year prior to enrollment, and who are naïve to natalizumab.

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