Telcagepant (MK-0974) Long-Term Safety Study in Adult Participants With Acute Migraine (MK-0974-012)

Summary

The purpose of this study is to investigate the safety and tolerability of telcagepant (MK-0974) in the long-term treatment of acute migraine in adult participants. The primary hypothesis of this study is that telcagepant is well tolerated in the long-term treatment of acute migraine in adult participants.

Timeline

Start

2007-02-21

Primary completion

2009-01-22

Completion

2009-01-22

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

registry Telcagepant 280 mg/300 mg vs Rizatriptan 10 mg; p <0.001; Treatment Difference -6.2 (95% CI -10.4 to -2.6) NCT00443209 ↗

registry Treatment Difference -5.2 (95% CI -11.7 to 1.4) NCT00443209 ↗

registry Treatment Difference 0.3 (95% CI -2.0 to 2.0) NCT00443209 ↗

Publications

• Results Connor KM, Aurora SK, Loeys T, Ashina M, Jones C, Giezek H, Massaad R, Williams-Diaz A, Lines C, Ho TW. Long-term tolerability of telcagepant for acute treatment of migraine in a randomized trial. Headache. 2011 Jan;51(1):73-84. doi: 10.1111/j.1526-4610.2010.01799.x. Epub 2010 Nov 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Telcagepant	Small molecule	280 mg	Oral
Subject	Telcagepant	Small molecule	300 mg	Oral
Comparator	rizatriptan	Unknown	10 mg	Oral

Indications