A Study to Test the Safety and Effectiveness of MK-0974 (Telcagepant) Co-administered With Ibuprofen or Acetaminophen in Patients With Migraines With or Without Aura (MK-0974-046)

Phase 2 Completed 683 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

This study will test the safety and how effective telcagepant is when taken with ibuprofen or acetaminophen in participants with migraine with or without aura. The primary study hypothesis is that at least one drug combination is superior to telecagepant alone in the treatment of acute migraines.

Timeline

Start: 2008-12-03
Primary completion: 2009-08-24
Completion: 2009-08-24

Outcome

Met primary endpoint

registry Placebo vs Telcagepant 280 mg +Ibuprofen 400 mg; p <0.001; Proportion difference 24.5 (90% CI 16.7 to 32.2) NCT00758836 ↗

registry Placebo vs Telcagepant 280 mg +APAP 1000 mg; p <0.001; Proportion difference 27.7 (90% CI 19.6 to 35.8) NCT00758836 ↗

registry Placebo vs Telcagepant 280 mg; p <0.001; Proportion difference 20.4 (90% CI 12.6 to 28.2) NCT00758836 ↗

Publications

Hewitt DJ, Martin V, Lipton RB, Brandes J, Ceesay P, Gottwald R, Schaefer E, Lines C, Ho TW. Randomized controlled study of telcagepant plus ibuprofen or acetaminophen in migraine. Headache. 2011 Apr;51(4):533-43. doi: 10.1111/j.1526-4610.2011.01860.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acetaminophen	Small molecule	1000 mg	Oral
Subject	Ibuprofen	Small molecule	400 mg	Oral
Subject	Telcagepant	Small molecule	280 mg	Oral