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.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01513291
First received: January 16, 2012
Last updated: October 16, 2012
Last verified: October 2012
  Purpose

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
Migraine
Headache
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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  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:
Headache
Migraine Disorders
Pain
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 July 24, 2014