Migraine MedDRA version: 9.1 Level: LLT Classification code 10027599 Term: Migraine
Conditions
Interventions
Product Name: MK-0974
Product Code: MK-0974
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: NA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 280-
Pha
Sponsors
MSD Finland Oy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. =18 years of age 2. History of migraine with or without aura > 1 year 3. =1 and =8 migraine days per month in the last 2 months that typically last from 4 to 72 hours untreated. 4. Willing to stay awake for at least 2 hours after administration of study medication 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: 1. > 50 years old at age of migraine onset. Difficulty distinguishing migraine from other headaches 2. Predominantly mild migraine attacks or attacks that usually resolve spontaneously in 15 headache-days/month or has taken medication for acute migraine or other headache on > 10 days/month in last 3 months. 5. Changed dose of prophylactic medication in last 3 months 6. Within 3 months of screening, has had myocardial infarction, unstable angina, coronary artery bypass surgery or other revascularization procedure, stroke, or transient ischemic attack. 7. Uncontrolled hypertension (> 160/100 mm Hg), uncontrolled diabetes, HIV disease, or significant pulmonary, renal, hepatic, endocrine, or other systemic disease 8. Malignancy = 5 years prior to signing consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or prostate cancer. 9. History of gastric or small intestinal surgery, or disease that causes malabsorption. 10. Hypersensitivity to or previous SAE in response to ibuprofen or acetaminophen. 11. Other confounding pain syndromes (i.e., condition requiring daily use of opioids), psychiatric condition such as major depression based on the criteria such as DSM-IV, dementia or significant neurological disorders other than migraine 12. Any clinically significant disease that might confound the results of the study, complicate the interpretation of the study results, interfere with the patient’s participation for the full duration of the study, or pose an additional undue risk to the patient. 13. Score =2 on item 9 of the PHQ-9 14. Patient has taken any of the following medications in the time frame specified: Time Frame 1 month prior to screening (and also prohibited throughout the study period) Therapy Potent CYP3A4 inhibitors cyclosporine, itraconazole, ketoconazole,, erythromycin, clarithromycin, telithromycin, nefazodone, HIV protease inhibitors Potent CYP3A4 inducers rifampicin, rifabutin, carbamazepine, phenytoin, barbiturates, systemic glucocorticoids, nevirapine, efavirenz, pioglitazone, primidone, St. Johns wort Specific CYP3A substrates astemizole, cisapride, pimozide, terfenadine Concomitant use of other CYP3A4 substrates is permitted with caution (e.g., theophylline, ergot derivatives) Concomitant use of other CYP3A4 and P-gp substrates is permitted, however, these medications should be administered with appropriate caution due to the potential for drug-drug interaction (e.g. quinidine, theophylline, ergot derivatives).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate the efficacy of MK-0974 co-administered with ibuprofen or acetaminophen/paracetamol compared to MK-0974 alone in the treatment of acute migraine, as measured by pain freedom at 2 hours post dose. 2. To evaluate the efficacy of MK-0974 co-administered with ibuprofen or acetaminophen/paracetamol compared to placebo in the treatment of acute migraine, as measured by pain freedom at 2 hours post dose. 3. To evaluate the safety and tolerability of MK-0974 co-administered with ibuprofen or acetaminophen/paracetamol in the treatment of acute migraine. ;Secondary Objective: 1. To evaluate the efficacy of MK-0974 compared to placebo in the treatment of acute migraine, as measured by pain freedom at 2 hours post dose. 2. To evaluate the efficacy of MK-0974 co-administered with ibuprofen or acetaminophen/paracetamol compared to MK-0974 alone in the treatment of acute migraine, as measured by pain relief at 2 hours post dose. ;Primary end point(s): Primary Efficacy Endpoint: Pain Freedom at 2 hours post dose, with pain freedom defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0. Primary Safety Variables: Safety and tolerability will be assessed by review of all safety parameters, including adverse experiences, laboratory values, ECG, and vital signs. | — |
Countries
Czech Republic, Finland, France, Germany, Hungary
Outcome results
None listed