EUCTR2007-002667-28-DE进行中（未招募）不适用
A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Multiple Attacks Studyto Compare the Efficacy and Safety of Oral MK-0974 With Placebo for the AcuteTreatment of Migraine With or Without Aura - Acute Treatment of Multiple Migraines With or Without Aura in Adults
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,834
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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