Pharmacokinetics & Drug Delivery | Neuropharmacology & Psychopharmacology | Headache | Methods for Diagnostic & Therapeutic Studies
Efficacy and tolerability of rizatriptan in pediatric migraineurs: results from a randomized, double-blind, placebo-controlled trial using a novel enrichment design
David J Hewitt*, Eric Pearlman, Donald Lewis, Mirja Hamalainen, Kathryn Connor, David Michelson, Ying Zhang, Lyn Harper-Mozley, Nancy Strickler, Robert Bachman, Erin Mahoney, Christopher Lines, Tony W Ho
*Corresponding author: David J Hewitt
Merck Sharp & Dohme Corp., Whitehouse Station, NJ, USA
F1000Posters 2012, 3: 659 (poster) [English]
54th American Headache Society Annual Meeting 2012, 21 - 24 Jun 2012, P31
It has been difficult to establish the efficacy of acute migraine treatments, including triptans, in pediatric migraineurs. Previously, we reported results from a trial that demonstrated that rizatriptan was effective on the primary endpoint of 2-hour pain freedom in 12-17 year olds (1). The trial also included a panel of 6-11 year olds. Here we report results for pre-specified secondary analyses of the combined 6-17 year-old population.
Rizatriptan treatment demonstrated a statistically significant difference versus placebo in eliminating pain and was generally well tolerated in migraine patients between 6 and 17 years of age.
Corresponding author David Hewitt, and coauthors Kathryn Connor, David Michelson,Ying Zhang, Lyn Harper Mozley, Nancy Strickler, Robert Bachman, Erin Mahoney, Christopher Lines, and Tony Ho are current or former employees of Merck Sharp and Dohme Corp. and own/owned stock/stock options in Merck Sharp and Dohme Corp.
Coauthors Eric Pearlman, Donald Lewis, and Mirja Hamalainen have received consulting fees from Merck Sharp and Dohme Corp.
Merck, not applicable
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