A Study of the Safety and Efficacy of MK-6096 for Migraine Prophylaxis in Participants With Episodic Migraine (MK-6096-020)
Condition: Migraine; Headache
MeSH terms: Migraine Disorders; Headache
Intervention: MK-6096; Placebo
Intervention description: MK-6096, two 5 mg tablets (total 10 mg dose), orally, once daily; Placebo, 2 tablets, orally, once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 237.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

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.
    

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.