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How To Validate A Novel Primary Endpoint: Ampyra's Lineup Of Pivotal Trial Endpoints & Analyses

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Acorda conducted two fundamentally identical Phase III trials for Ampyra (dalfampridine), studies MS-F203 and MS-F204. The trials, with a novel primary endpoint for the multiple sclerosis setting, were conducted under Special Protocol Assessments from FDA. Since the primary endpoint was untested and for an unprecedented indication (and involved a complex analysis plan), the secondary endpoints were of particular importance in providing reassurance of the drug's effect.

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