A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine in Children and Adolescents (MK-0462-082 AM7)

Summary

This Clinical Trial evaluates the Safety and Efficacy of Rizatriptan for the Acute Treatment of Migraine in Children and Adolescents.

Timeline

Start

2009-11-30

Primary completion

2011-04-21

Completion

2011-04-21

Outcome

Met primary endpoint

registry analysis (unspecified test); Rizatriptan vs Placebo; p = 0.025; Odds Ratio (OR) 1.55 (95% CI 1.06 to 2.26); NCT01001234 ↗

paper A higher proportion of 12-17-year-olds on rizatriptan had pain freedom at 2 hours compared with those on placebo PMID 22711898 ↗

Publications

• Ho TW, Pearlman E, Lewis D, Hamalainen M, Connor K, Michelson D, Zhang Y, Assaid C, Mozley LH, Strickler N, Bachman R, Mahoney E, Lines C, Hewitt DJ; Rizatriptan Protocol 082 Pediatric Migraine Study Group. Efficacy and tolerability of rizatriptan in pediatric migraineurs: results from a randomized, double-blind, placebo-controlled trial using a novel adaptive enrichment design. Cephalalgia. 2012 Jul;32(10):750-65. doi: 10.1177/0333102412451358. Epub 2012 Jun 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	rizatriptan	Unknown	5 mg	Oral
Subject	rizatriptan	Unknown	10 mg	Oral

Indications