Abstract
Purpose: Adaptive seamless Phase II/III designs are attractive, and have been proposed for neurological settings such as: stroke, amyotrophic lateral sclerosis and pain control. In essence, they commence with a multi-arm stage, stopping treatments or treatment doses, for futility in an interim analysis (eg based on early biological markers), whilst taking the promising compound(s)/ dose(s) through to the final stage. Despite the advent of a raft of novel drug strategies in multiple sclerosis (MS) which reduce relapse rate, the problem of trying to slow or stop disease progression remains intractable. We explored the feasibility of implementing an adaptive seamless design (ASD) in the context of secondary progressive multiple sclerosis (SPMS).
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