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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
First received: January 16, 2012
Last updated: October 16, 2012
Last verified: October 2012

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 Period 1, during which baseline number of monthly migraine days will be assessed, participants will be randomized to receive MK-6096 or placebo for a 12-week treatment period (Period 2). Participants who complete all 12 weeks of Period 2 will receive drug or placebo for an additional 2 weeks (Period 3). Treatment assignment in Period 3 was determined at the initial randomization. In Period 3, participants who received placebo in Period 2 will continue to receive placebo and participants who received MK-6096 in Period 2 will receive either MK-6096 or placebo in a 1:1 ratio.

Condition Intervention Phase
Drug: MK-6096
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Mean Change from Baseline in Monthly Migraine Days [ Time Frame: Baseline and average over treatment period (Weeks 0-12) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Change from Baseline in Monthly Headache Days [ Time Frame: Baseline and average over treatment period (Weeks 0-12) ] [ Designated as safety issue: No ]
  • Number of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days [ Time Frame: Baseline and average over treatment period (Weeks 0-12) ] [ Designated as safety issue: No ]
  • Number of Participants With at Least a 30% Reduction From Baseline in Monthly Migraine Days [ Time Frame: Baseline and average over treatment period (Weeks 0-12) ] [ Designated as safety issue: No ]

Enrollment: 237
Study Start Date: February 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-6096
Period 2 - Double-blind MK-6096; Period 3 - Double-blind MK-6096 or placebo in 1:1 ratio
Drug: MK-6096
MK-6096, two 5 mg tablets (total 10 mg dose), orally, once daily
Placebo Comparator: Placebo
Period 2 and Period 3 - Double-blind placebo
Drug: Placebo
Placebo, 2 tablets, orally, once daily


Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 ECG evidence of uncontrolled hypertension, uncontrolled diabetes, 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.
  Contacts and Locations
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  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01513291     History of Changes
Other Study ID Numbers: 6096-020
Study First Received: January 16, 2012
Last Updated: October 16, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Migraine Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014