Migraine MedDRA version: 9.1 Level: LLT Classification code 10027599 Term: Migraine
Conditions
Interventions
Product Name: MK-0974
Product Code: MK-0974
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 140-
Pharmaceutical form of the placebo: Tab
Sponsors
Merck Sharp & Dohme (Sweden) AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Patient has had a history of migraine with or without aura > 1 year with = 1 and = 8 moderate or severe migraine attacks per month in the 2 months prior to screening that typically last between 4 to 72 hours untreated (see Appendix 6.1 and ICHD II Attachment for IHS migraine definitions). b. Women and men of childbearing potential must use acceptable contraception throughout the trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a. Patient has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours. b. Patient has basilar or hemiplegic migraine headache. c. Patient has 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 3 months prior to screening. d. Patient is taking migraine prophylactic medication where the prescribed daily dose has changed during the 3 months prior to screening. e. Patient was > 50 years old at age of migraine onset. f. Patient has clinical, laboratory, or ECG evidence of uncontrolled hypertension (defined as SBP of =150 mm Hg and/or DBP of =95 mm Hg), uncontrolled diabetes, HIV disease, or significant pulmonary, renal, hepatic, endocrine, or other systemic disease in the opinion of the investigator. g. Patient has myocardial infarction, unstable angina, coronary artery bypass surgery, or other revascularization procedure, stroke, or transient ischemic attack within 3 months of screening. h. Patient has taken any of the following medications in 1 mo. prior to screening and throughout the study period: -Potent CYP3A4 inhibitors, including but not limited to: (e.g. cyclosporine, systemic (oral/IV) itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, nefazodone, HIV protease inhibitors) -Potent CYP3A4 inducers, including but not limited to: rifampicin, rifabutin, carbamazepine, phenytoin, barbiturates, systemic glucocorticoids (replacements and inhaled are permitted), nevirapine, efavirenz, pioglitazone, primidone, St. Johns wort -Specific CYP3A4 substrates: cisapride, pimozide, astemizole, terfenadine. Concomitant use of other CYP3A4 substrates is permitted, however, these medications should be administered with appropriate caution due to the potential for drug-drug interaction (e.g., theophylline, ergot derivatives) i. Patient has previously treated with study medication in a MK-0974 study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: a. To evaluate the efficacy and safety of MK-0974 compared to placebo in the treatment of acute migraine. b. To evaluate the safety and the consistency of efficacy of MK-0974 across multiple migraine attacks. ;Secondary Objective: a. To evaluate the efficacy of MK-0974 (280 mg and 140 mg) compared to placebo in the treatment of acute migraine, as measured using sustained pain freedom from 2-24 hours and 2-48 hours post-dose and total migraine freedom at 2 hours and from 2-24 hours postdose (first attack only);Primary end point(s): Primary Efficacy Endpoints a. Pain Freedom (PF) at 2 hours post-dose, with pain freedom defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0. b. Pain Relief (PR) at 2 hours post-dose, with pain relief defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0. c. Pain Freedom Consistency (PFC) at 2 hours post-dose, defined as having achieved PF at 2 hours post-dose on at least 3 treated attacks. Note that for the control groups, a positive PF response arising from the administration of the one MK-0974 treated attack will count as one of the 3 positive PF responses needed to fulfill the criteria for PFC. d. Pain Relief Consistency (PRC) at 2 hours post-dose, defined as having achieved PR at 2 hours post-dose on at least 3 treated attacks. Note that for the control groups, a positive PR response arising from the administration of the one MK-0974 treated attack will count as one of the 3 positive PR responses needed to fulfill the criteria for PRC. e. Absence of Photophobia at 2 hours post-dose. f. Absence of Phonophobia at 2 hours post-dose. g. Absence of Nausea at 2 hours post-dose. Primary Safety Endpoints a. Safety and tolerability will be assessed by review of all safety parameters, including adverse experiences, laboratory values, ECGs, and vital signs. | — |
Countries
Austria, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed