Clinical trial NCT01613248: A Dose-Finding Study of MK-1602 in the Treatment of Acute Migraine (MK-1602-006)
Official title: A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding 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: 2012-06-07
Enrollment: 834
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 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

Primary outcomes:
measure: Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants Reporting Pain Relief (PR) at 2 Hours Post-Dose
timeFrame: 2 hours post-dose
measure: Number of Participants With One or More Adverse Events Within 48 Hours Post-Dose
timeFrame: Up to 48 hours post-dose
measure: Number of Participants With One or More Adverse Events Within 14 Days Post-Dose
timeFrame: Up to 14 days post-dose
measure: Number of Participants Who Discontinued From Study Due to Adverse Events
timeFrame: Up to 5 weeks post-dose
Secondary outcomes:
measure: Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose
timeFrame: 2 hours post-dose
measure: Percentage of Participant Reporting Absence of Photophobia at 2 Hours Post-Dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants Reporting Sustained Pain Freedom (SPF) 2-24 Hours Post-Dose
timeFrame: 2-24 hours post-dose
measure: Percentage of Participants Reporting SPF 2-48 Hours Post-Dose
timeFrame: 2-48 hours post-dose
measure: Percentage of Participants Reporting Sustained Pain Relief (SPR) 2-24 Hours Post-Dose
timeFrame: 2-24 hours post-dose
measure: Percentage of Participants Reporting SPR 2-48 Hours Post-Dose
timeFrame: 2-48 hours post-dose
measure: Percentage of Participants Reporting Total Migraine Freedom (TMF) at 2 Hours Post-Dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants Reporting TMF at 2-24 Hours Post-Dose
timeFrame: 2-24 hours post-dose
measure: Percentage of Participants Reporting TMF at 2-48 Hours Post-Dose
timeFrame: 2-48 hours post-dose
Other outcomes:
Locations:
Study officials:
References:
citation: Voss T, Lipton RB, Dodick DW, Dupre N, Ge JY, Bachman R, Assaid C, Aurora SK, Michelson D. A phase IIb randomized, double-blind, placebo-controlled trial of ubrogepant for the acute treatment of migraine. Cephalalgia. 2016 Aug;36(9):887-98. doi: 10.1177/0333102416653233. Epub 2016 Jun 6.