Multiple Attacks Study to Compare the Efficacy and Safety of MK-0974 With Placebo for Acute Migraine (MK-0974-031)

Summary

The purpose of the study is to assess the safety and efficacy of telcagepant (MK-0974) in acute treatment of multiple migraine attacks with or without aura. Primary hypotheses of this study are that telcagepant is superior to placebo, as measured by the proportion of participants who have pain freedom, pain relief, pain freedom consistency, pain relief consistency, and absence of photophobia, phonophobia, and nausea at 2 hours post-dose.

Timeline

Start

2008-08-14

Primary completion

2009-03-25

Completion

2009-03-25

Outcome

Met primary endpoint

registry analysis (superiority or other test); Telcagepant 140 mg vs Placebo; p <0.001; Odds Ratio (OR) 2.54 (95% CI 1.80 to 3.58); Regression, Logistic NCT00483704 ↗

paper The percentage of patients with 2-hour pain freedom consistency and 2-hour pain relief consistency was significantly (p < .001) higher for both telcagepant treatment sequences versus control. PMID 20974601 ↗

Publications

• Ho AP, Dahlof CG, Silberstein SD, Saper JR, Ashina M, Kost JT, Froman S, Leibensperger H, Lines CR, Ho TW. Randomized, controlled trial of telcagepant over four migraine attacks. Cephalalgia. 2010 Dec;30(12):1443-57. doi: 10.1177/0333102410370878. Epub 2010 Jun 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Telcagepant	Small molecule	140 mg	Oral
Subject	Telcagepant	Small molecule	280 mg	Oral

Indications