The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.
Abstract Details
Activity Number:
|
416
|
Type:
|
Contributed
|
Date/Time:
|
Tuesday, August 2, 2011 : 2:00 PM to 3:50 PM
|
Sponsor:
|
Biopharmaceutical Section
|
Abstract - #301574 |
Title:
|
Design and Execution of a Two-Stage Adaptive Design in Pediatric Migraine
|
Author(s):
|
Christopher Assaid*+ and Ying Zhang and Xiaoyin Frank Fan and Tony W. Ho
|
Companies:
|
Merck & Co., Inc. and Merck & Co., Inc. and Vertex Pharmaceuticals and Merck & Co., Inc.
|
Address:
|
351 North Sumneytown Pike, North Wales, PA, 19454-2505,
|
Keywords:
|
Adaptive Design ;
Placebo Effect ;
Migraine ;
Pediatric Clinical Trials
|
Abstract:
|
Treatments that have been demonstrated to be effective in reducing/eliminating migraine-related pain and associated symptoms have historically failed to demonstrate efficacy in pediatric patients. One observation from completed trials is that the placebo response rate tends to be substantially higher in pediatric trials as compared to adult trials, leading to the potential for a ceiling effect.
In this presentation we will describe the multitude of historical challenges and potential theories that might explain the null results of these trials. We will also describe aspects of a novel adaptive design that were identified with a goal of maximizing the probability of success of a trial of a well-established, effective (in adults) treatment of acute migraine in pediatric patients. Additional discussion will surround some of the logistical issues associated with an adaptive design in acute migraine, particularly around multiple randomizations in a short time window for pediatric patients.
|
The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
Back to the full JSM 2011 program
|
2011 JSM Online Program Home
For information, contact jsm@amstat.org or phone (888) 231-3473.
If you have questions about the Continuing Education program, please contact the Education Department.