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

NCT ID: NCT01513291

Last Updated: 2018-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 237 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-06
• Study Completion Date: 2012-10-03

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

MK-6096

Participants were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period. Those who completed the Treatment Period were randomized 1:1 to receive double-blind MK-6096 or placebo once daily in the 2-week Run-out Period.

Group Type: EXPERIMENTAL

MK-6096

Intervention Type: DRUG

MK-6096, two 5 mg tablets (total 10 mg dose), orally, once daily

Placebo

Intervention Type: DRUG

Placebo, 2 tablets, orally, once daily

Placebo

Participants were randomized to receive double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period. Those who completed the Treatment Period continued to receive double-blind placebo once daily in the 2-week Run-out Period.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo, 2 tablets, orally, once daily

Interventions

MK-6096

MK-6096, two 5 mg tablets (total 10 mg dose), orally, once daily

Intervention Type: DRUG

Placebo

Placebo, 2 tablets, orally, once daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• History of migraine with or without aura for >1 year and with ≥4 and ≤14 migraine days per month in the 3 months prior to study
• Male, female not of reproductive potential, or female of reproductive potential who is not pregnant by pregnancy test and agrees to use acceptable contraception

Exclusion Criteria

• Pregnancy, breast-feeding, or expecting to become pregnant
• Planning to donate egg or sperm during the study or within 90 days after last dose of study medication
• Basilar or hemiplegic migraine headache
• >50 years old at the age of migraine onset
• ≥15 headache-days per month or medication taken for acute migraine or other headaches on more than 10 days per month in any of the three months prior to study
• Migraine prophylactic medication (defined as medication taken daily to prevent migraines) taken in the 30 days prior to study
• History of narcolepsy, cataplexy, circadian rhythm disorder, parasomnia, sleep related breathing disorder, restless legs syndrome, periodic limb movement disorder, excessive daytime sleepiness or difficulty sleeping due to a medical condition (e.g., asthma, gastroesophageal reflux disease, etc.)
• Clinical, laboratory, or electrocardiogram (ECG) evidence of uncontrolled hypertension, uncontrolled diabetes, human immunodeficiency virus (HIV) disease, or significant pulmonary, renal, hepatic, endocrine, or other systemic disease
• Myocardial infarction, unstable angina, coronary artery bypass surgery, or other revascularization procedure, stroke, or transient ischemic attack within 3 months of study
• Other confounding pain syndromes (i.e., condition requiring daily use of opioids), psychiatric conditions such as uncontrolled major depression, dementia or significant neurological disorders other than migraine
• Imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS), or of harm to others. Exclude any prospective participant reporting suicidal ideation with intent, with or without a plan in the past 2 months or suicidal behavior in the past 6 months
• History of malignancy ≤5 years prior to study, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
• History of hypersensitivity to more than two chemical classes of drugs, including prescription and over-the-counter medications
• Recent history (within the past 1 year) or current evidence of drug or alcohol abuse or "recreational use" of illicit drugs or prescription medications
• Donated blood products or has had phlebotomy of >300 ml within 8 weeks of study, or intends to donate blood products or receive blood products within 30 days before study and throughout study
• Consumption of 3 or more alcoholic drinks per day
• Body Mass Index >40 kg/m^2
• History of transmeridian travel (across >3 time zones) or shift work (defined as permanent night shift or rotating day/night shift work) within the past 2 weeks or anticipates needing to travel (across >3 time zones) at any time during the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Chabi A, Zhang Y, Jackson S, Cady R, Lines C, Herring WJ, Connor KM, Michelson D. Randomized controlled trial of the orexin receptor antagonist filorexant for migraine prophylaxis. Cephalalgia. 2015 Apr;35(5):379-88. doi: 10.1177/0333102414544979. Epub 2014 Aug 8.

Reference Type: BACKGROUND

PMID: 25106663 (View on PubMed)

Other Identifiers

6096-020

Identifier Type: -

Identifier Source: org_study_id