A Dose-Finding Study of MK-1602 in the Treatment of Acute Migraine (MK-1602-006 AM1)
Status: | Completed |
---|---|
Conditions: | Migraine Headaches |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | Any |
Updated: | 9/23/2012 |
Start Date: | July 2012 |
End Date: | January 2013 |
Contact: | Toll Free Number |
Phone: | 1-888-577-8839 |
A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of MK-1602 in the Treatment of Acute Migraine
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.
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
We found this trial at
52
sites
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