a dose-finding study of mk-1602 in the treatment of acute migraine (mk-1602-006)

Conditions: Migraine

Summary: the purpose of this study is to assess the effectiveness, safety and tolerability of a range of doses of mk-1602 versus placebo in the treatment of acute migraine.


Eligibility criteria:
inclusion criteria: * \> 1 year history of migraine with or without aura as defined by international headache society (ihs) criteria 1.1 and/or 1.2 * migraines typically last between 4 to 72 hours, if untreated * ≥ 2 and ≤ 8 moderate or severe migraine attacks per month in each of the two months prior to screening * male, female who is not of reproductive potential, or female of reproductive potential with a screening serum β-human chorionic gonadotropin (β-hcg) level consistent with a not-pregnant state, and who agrees to use acceptable contraception exclusion criteria: * pregnant or breast-feeding, or is a female expecting to conceive within the projected duration of study participation * participant has difficulty distinguishing his/her migraine attacks from tension-type headaches * history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than two hours * more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in any of the three months prior to screening * basilar-type or hemiplegic migraine headache * \> 50 years old at age of migraine onset * taking migraine prophylactic medication where the prescribed daily dose has changed during the 3 months prior to screening and will not be changed during the study * taking a proton pump inhibitor (ppi) or a histamine receptor 2 (h2) blocker on a daily or near daily basis (\> 3 days per week) * taking the following medications from 1 month prior to screening through study period: potent cytochrome p450 (cyp) 3a4 inhibitors (e.g., cyclosporine, itraconazole, ketoconazole, fluconazole, erythromycin, clarithromycin, nefazodone, telithromycin, cimetidine, quinine, diltiazem, verapamil, and human immunodeficiency virus \[hiv\] protease inhibitors), moderate or marked cyp3a4 inducers (e.g., rifampicin, rifabutin, barbiturates \[e.g., phenobarbital and primidone\], systemic glucocorticoids, nevirapine, efavirenz, pioglitazone, carbamazepine, phenytoin, and st. johns wort), or drugs with narrow therapeutic margins and potential for drug interactions in the cyp2c family (e.g., warfarin) * participant is unable to refrain from consumption of grapefruit or grapefruit juice during study * history of hypersensitivity to, or has experienced a serious adverse event in response to 3 or more classes of drugs (prescription and over-the-counter) * clinical or laboratory evidence of uncontrolled diabetes, human immunodeficiency virus (hiv) disease, or significant pulmonary, renal, hepatic, endocrine, or other systemic disease * other confounding pain syndromes, psychiatric conditions such as uncontrolled major depression, dementia or significant neurological disorders other than migraine. patients who are currently being treated with non-prohibited medication for depression and symptoms are well controlled are eligible to participate * participant is at imminent risk of self-harm * 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 gastric or small intestinal surgery (including gastric bypass surgery or banding), or presence of a disease that causes malabsorption * participant has recent history (within the last year) of drug or alcohol abuse or dependence or is a user of recreational or illicit drugs * participant is legally or mentally incapacitated * donation of blood products or phlebotomy of \> 300 ml within 8 weeks of study, or intent to donate blood products or receive blood products within 30 days of screening and throughout study * intent to donate eggs or sperm within the projected duration of the study * current participation in or participation within 30 days of screening in a study with an investigational compound or device * previous exposure to mk-0974 and/or mk-3207 * use within the past 2 months of an opioid- or barbiturate-containing analgesic for migraine relief * inpatient or emergency department treatment of an acute migraine attack within the past 2 months