NCT01513291

A Study of the Safety and Efficacy of MK-6096 for Migraine Prophylaxis in Participants With Episodic Migraine (MK-6096-020)

A Phase IIa, Multicenter, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-6096 for Migraine Prophylaxis in Patients With Episodic Migraine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 237 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine
• Headache

Interventions

Type	Name	Description
DRUG	MK-6096	MK-6096, two 5 mg tablets (total 10 mg dose), orally, once daily
DRUG	Placebo	Placebo, 2 tablets, orally, once daily

Timeline

• Start date: 2012-02-06
• Primary completion: 2012-10-03
• Completion: 2012-10-03
• First posted: 2012-01-20
• Last updated: 2018-11-07
• Results posted: 2016-07-20