A Dose-Finding Study of MK-1602 in the Treatment of Acute Migraine (MK-1602-006)

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan

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