Status:
COMPLETED
A Study of the Safety and Efficacy of MK-6096 for Migraine Prophylaxis in Participants With Episodic Migraine (MK-6096-020)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Migraine
Headache
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 6 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2012
Estimated Enrollment :
237 Patients enrolled
Trial Details
Trial ID
NCT01513291
Start Date
February 6 2012
End Date
October 3 2012
Last Update
November 7 2018
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