Telcagepant for Prevention of Menstrually Related Migraine in Female Participants With Episodic Migraine (MK-0974-065)

Phase 2/3 Completed 4548 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a multicenter study to test the hypothesis that telcagepant is superior to placebo in preventing perimenstrual migraines as measured by mean monthly headaches during the entire treatment period. This study will also evaluate the safety and tolerability of telcagepant for female migraine participants.

Timeline

Start: 2010-06-01
Primary completion: 2011-04-08
Completion: 2011-04-08

Outcome

Missed primary endpoint

registry p = 0.130; Mean Difference (Final Values) -0.5 (95% CI -1.1 to 0.1) NCT01125774 ↗

paper Telcagepant did not reduce monthly headache frequency, but did reduce perimenstrual headaches. PMID 25926620 ↗

Publications

Results Ho TW, Ho AP, Ge YJ, Assaid C, Gottwald R, MacGregor EA, Mannix LK, van Oosterhout WP, Koppenhaver J, Lines C, Ferrari MD, Michelson D. Randomized controlled trial of the CGRP receptor antagonist telcagepant for prevention of headache in women with perimenstrual migraine. Cephalalgia. 2016 Feb;36(2):148-61. doi: 10.1177/0333102415584308. Epub 2015 Apr 29.

Drugs

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