A Study of the Safety and Efficacy of MK-6096 for Migraine Prophylaxis in Participants With Episodic Migraine (MK-6096-020)
Status:
Completed
Trial end date:
2012-10-03
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the safety and efficacy of MK-6096 versus placebo
for preventing migraines in participants with episodic migraine. After a 28-day Screening
period during which baseline number of monthly migraine days was assessed, participants were
randomized to receive MK-6096 or placebo for a 12-week Treatment Period. Participants who
completed all 12 weeks of the Treatment Period received drug or placebo for an additional 2
weeks in the Run-out Period. Treatment assignment in the Run-out Period was determined at the
initial randomization. In the Run-out Period, participants who received placebo in the
Treatment Period continued to receive placebo and participants who received MK-6096 in the
Treatment Period 2 received either MK-6096 or placebo in a 1:1 ratio. The hypothesis tested
in the study is that MK-6096 10 mg is superior to placebo in reducing migraine frequency as
measured by the mean change from baseline in monthly migraine days averaged over the 12- week
treatment period.