A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Multiple Attacks Study to Compare the Efficacy and Safety of Oral MK-0974 With Placebo for the Acute Treatment of Migraine With or Without Aura - Acute Treatment of Multiple Migraines With or Without Aura in Adults
- Conditions
- MigraineMedDRA version: 9.1 Level: LLT Classification code 10027599 Term: Migraine
- Registration Number
- EUCTR2007-002667-28-GB
- Lead Sponsor
- Merck & Co. Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1834
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.
C. Patient understands study procedures, alternative treatments and riss of the study and agrees to give written informed consent.
d.Patient is able to complete study questionnaire and diary.
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method