Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Allergan
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
\> 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
You may not be if
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 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, modafinil 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, 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
History or current evidence of any condition, therapy, lab abnormality or
other circumstance that might confound the results of the study, or interfere with subject's participation for the full duration of the study
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, with the exception of MK-1602 Protocol 006
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
Clareo Health | A Pharmacokinetic Study of MK-1602 in the Treatment of Acute Migraine (MK-1602-007)
