A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of MK-1602 in the Treatment of Acute Migraine
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Allergan
- Enrollment
- 834
- Primary Endpoint
- Number of Participants With One or More Adverse Events Within 48 Hours Post-Dose
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
MK-1602 1 mg
MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
Intervention: MK-1602 (Drug)
MK-1602 1 mg
MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
Intervention: Rescue medication (Drug)
MK-1602 10 mg
MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
Intervention: MK-1602 (Drug)
MK-1602 10 mg
MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
Intervention: Rescue medication (Drug)
MK-1602 25 mg
MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
Intervention: MK-1602 (Drug)
MK-1602 25 mg
MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
Intervention: Rescue medication (Drug)
MK-1602 50 mg
MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
Intervention: MK-1602 (Drug)
MK-1602 50 mg
MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
Intervention: Rescue medication (Drug)
MK-1602 100 mg
MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
Intervention: MK-1602 (Drug)
MK-1602 100 mg
MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
Intervention: Rescue medication (Drug)
Placebo
Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
Intervention: Placebo-matching MK-1602 (Drug)
Placebo
Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
Intervention: Rescue medication (Drug)
Outcomes
Primary Outcomes
Number of Participants With One or More Adverse Events Within 48 Hours Post-Dose
Time Frame: Up to 48 hours post-dose
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a sponsor product, whether or not considered related to the use of the product.
Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose
Time Frame: 2 hours post-dose
PF was defined as a reduction in headache severity from Grade 2 or 3 at Baseline to Grade 0. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain.
Percentage of Participants Reporting Pain Relief (PR) at 2 Hours Post-Dose
Time Frame: 2 hours post-dose
PR was defined as a reduction of a moderate or severe migraine headache (Grade 2 or 3) at Baseline to a mild headache or no headache (Grade 1 or 0) 2 hours post-dose. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain.
Number of Participants Who Discontinued From Study Due to Adverse Events
Time Frame: Up to 5 weeks post-dose
Number of Participants With One or More Adverse Events Within 14 Days Post-Dose
Time Frame: Up to 14 days post-dose
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a sponsor product, whether or not considered related to the use of the product.
Secondary Outcomes
- Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose(2 hours post-dose)
- Percentage of Participants Reporting Sustained Pain Freedom (SPF) 2-24 Hours Post-Dose(2-24 hours post-dose)
- Percentage of Participants Reporting SPF 2-48 Hours Post-Dose(2-48 hours post-dose)
- Percentage of Participants Reporting Sustained Pain Relief (SPR) 2-24 Hours Post-Dose(2-24 hours post-dose)
- Percentage of Participants Reporting SPR 2-48 Hours Post-Dose(2-48 hours post-dose)
- Percentage of Participants Reporting Total Migraine Freedom (TMF) at 2 Hours Post-Dose(2 hours post-dose)
- Percentage of Participants Reporting TMF at 2-24 Hours Post-Dose(2-24 hours post-dose)
- Percentage of Participants Reporting TMF at 2-48 Hours Post-Dose(2-48 hours post-dose)
- Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose(2 hours post-dose)
- Percentage of Participant Reporting Absence of Photophobia at 2 Hours Post-Dose(2 hours post-dose)