a study of the safety and efficacy of mk-6096 for migraine prophylaxis in participants with episodic migraine (mk-6096-020)

Conditions: Migraine; Headache

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.