This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 584
Type: Contributed
Date/Time: Wednesday, August 4, 2010 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #306804
Title: Total Migraine Freedom: A Potential Primary Endpoint to Assess Acute Treatment in Migraine
Author(s): Anthony J. Rodgers*+
Companies: Merck & Co., Inc.
Address: PO Box 1000, North Wales, PA, 19454, USA
Keywords: Simulation ; Composite Endpoint ; Bootstrap Sampling ; Correlated Endpoints ; Pre-treatment Education ; Early vs. Late Intervention
Abstract:

The FDA has set a higher regulatory hurdle for registration of new migraine agents, now requiring that efficacy not only be established for pain relief, but also for the absence of the associated symptoms of phonophobia, photophobia, and nausea at 2 hours post-dose. Simulations were conducted across a range of treatment paradigms to both demonstrate the impact of the high regulatory hurdle as well as to examine the potential use of a single primary composite endpoint (total migraine freedom), as a viable alternative endpoint. The simulations utilized a comprehensive dataset that was constructed from multiple phase III+ migraine studies conducted by Merck. Results showed a substantial loss of power under the new regulatory requirement (joint significance of four endpoints) as compared to the composite endpoint of total migraine freedom.


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