Clinical trial NCT01657370: A Pharmacokinetic Study of MK-1602 in the Treatment of Acute Migraine (MK-1602-007)
Official title: A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Pharmacokinetic Study of MK-1602 in the Treatment of Acute Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-08-06
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to characterize the pharmacokinetics of MK-1602 in the treatment of acute migraine, including the influence of demographic and other variables on MK-1602 pharmacokinetics, and to evaluate the relationship between MK-1602 concentrations and efficacy of the drug.


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 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

Primary outcomes:
measure: Dry Blood Spot (DBS) MK-1602 Concentration at 2 Hours Post-Dose on Migraine Treatment Day
timeFrame: 2 hours post dose 1
measure: Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose on Migraine Treatment Day
timeFrame: 2 hours post dose 1
measure: Percentage of Participants With Pain Relief (PR) at 2 Hours Post-Dose on Migraine Treatment Day
timeFrame: 2 hours post dose 1
Secondary outcomes:
measure: Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose on Migraine Treatment Day
timeFrame: 2 hours post dose 1
measure: Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-Dose on Migraine Treatment Day
timeFrame: 2 hours post dose 1
measure: Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose on Migraine Treatment Day
timeFrame: 2 hours post dose 1
measure: Percentage of Participants With Sustained Pain Freedom (SPF) From 2-24 Hours Post-Dose on Migraine Treatment Day
timeFrame: 2-24 hours post dose 1
measure: Percentage of Participants With Sustained Pain Relief (SPR) From 2-24 Hours Post-Dose on Migraine Treatment Day
timeFrame: 2-24 hours post dose 1
measure: Percentage of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose on Migraine Treatment Day
timeFrame: 2 hours post dose 1
measure: Percentage of Participants With TMF From 2-24 Hours Post-Dose on Migraine Treatment Day
timeFrame: 2-24 hours post dose 1
Other outcomes:
measure: Dry Blood Spot (DBS) MK-1602 Concentrations on Migraine Treatment Day
timeFrame: Up to 24 hours post dose 1
measure: Dry Blood Spot MK-1602 Concentration at 3.5 Hours Post-Dose at Visit 2 (Day 4)
timeFrame: 3.5 hours post dose 3
measure: Plasma MK-1602 Concentrations at Visit 2 (Day 4)
timeFrame: Up to 3.5 hours post dose 3
Locations:
Study officials:
References: