A Dose-Finding Study of MK-1602 in the Treatment of Acute Migraine (MK-1602-006)
- Conditions
- Migraine
- Interventions
- Drug: MK-1602Drug: Placebo-matching MK-1602Drug: Rescue medication
- Registration Number
- NCT01613248
- Lead Sponsor
- Allergan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 834
- > 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MK-1602 1 mg MK-1602 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. MK-1602 1 mg Rescue medication 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. MK-1602 10 mg MK-1602 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. MK-1602 10 mg Rescue medication 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. MK-1602 25 mg MK-1602 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. MK-1602 25 mg Rescue medication 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. MK-1602 50 mg MK-1602 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. MK-1602 50 mg Rescue medication 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. MK-1602 100 mg MK-1602 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. MK-1602 100 mg Rescue medication 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. Placebo Placebo-matching MK-1602 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. Placebo Rescue medication 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.
- Primary Outcome Measures
Name Time Method Number of Participants With One or More Adverse Events Within 48 Hours Post-Dose 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 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 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 With One or More Adverse Events Within 14 Days Post-Dose 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.
Number of Participants Who Discontinued From Study Due to Adverse Events Up to 5 weeks post-dose
- Secondary Outcome Measures
Name Time Method 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 SPF was defined as PF at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a mild/moderate/severe headache during the 24 hour period after dosing with study medication.
Percentage of Participants Reporting SPF 2-48 Hours Post-Dose 2-48 hours post-dose SPF was defined as PF at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a mild/moderate/severe headache during the 48 hour period after dosing with study medication.
Percentage of Participants Reporting Sustained Pain Relief (SPR) 2-24 Hours Post-Dose 2-24 hours post-dose SPR was defined as PR at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the 24 hour period after dosing with study medication.
Percentage of Participants Reporting SPR 2-48 Hours Post-Dose 2-48 hours post-dose SPR was defined as PR at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the 48 hour period after dosing with study medication.
Percentage of Participants Reporting Total Migraine Freedom (TMF) at 2 Hours Post-Dose 2 hours post-dose TMF at 2 hours post dose was defined as PF with no photophobia, phonophobia, nausea, or vomiting at 2 hours post-dose.
Percentage of Participants Reporting TMF at 2-24 Hours Post-Dose 2-24 hours post-dose TMF at 2-24 hours post-dose was defined as SPF with no photophobia, phonophobia, nausea, or vomiting during the 2 to 24 hour period after dosing with study medication.
Percentage of Participants Reporting TMF at 2-48 Hours Post-Dose 2-48 hours post-dose TMF at 2-48 hours post-dose was defined as SPF with no photophobia, phonophobia, nausea, or vomiting during the 2 to 48 hour period after dosing with study medication.
Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose 2 hours post-dose Phonophobia is sensitivity to loud sounds.
Percentage of Participant Reporting Absence of Photophobia at 2 Hours Post-Dose 2 hours post-dose Photophobia is sensitivity to bright light.