An Investigation of the Safety and Utility of Treximet in the Treatment of Menstrual Migraine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Total dose of study medication
研究概览
简要总结
The study is to primarily investigate whether Treximet® (Imitrex RT/naproxen sodium 500mg) taken at the first onset of menstrual migraine will both terminate the acute headache and assist in preventing headache recurrence and the need for repeat abortive therapy over the ensuing days of menses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Actively and regularly cycling females age 19 years or greater.
- •Normal (for subject) menses within 6 weeks prior to randomization
- •History of migraine of ≤ 1 years duration by International Classification of Headache Disorders (ICHD) criteria
- •History of menstrual migraine by ICHD criteria
排除标准
- •Not actively practicing adequate contraception or intending to continue to do so during the treatment.
- •15 or more days of headache during each of the prior 3 months
- •Prior use of Treximet for the treatment of menstrual migraine
- •Uncontrolled hypertension
- •Hemiplegic or basilar migraine
- •Clinical evidence of coronary artery disease or other clinically significant and relevant cardiac disease (e.g. vasospastic angina)
- •History of stroke or transient ischemic attack
- •History of ischemic bowel disease
- •Clinically significant hepatic disease
- •History of allergy to any NSAID or triptan
- •History of gastritis, peptic ulcer disease, GI bleeding, gastric surgery
结局指标
主要结局
Total dose of study medication
时间窗: 90 days
Endpoints will include (a) total doses of study medication taken (primary endpoint), (b) total doses of rescue medication taken, (c) total "migraine days", (d) total "headache days", (e) days of functionally incapacitating headache, (f) work-related absenteeism, (g) unscheduled visits for acute headache treatment, (h) cost of unscheduled visits for acute headache treatment, (i) safety and tolerability, and (j) patient satisfaction.
次要结局
- total doses of rescue medication taken(90 days)
- total "headache days"(90 days)
- days of functionally incapacitating headache(90 days)
- work-related absenteeism(90 days)
- unscheduled visits for acute headache treatment(90 days)
- cost of unscheduled visits for acute headache treatment(90 days)
- safety and tolerability(90 days)
- patient satisfaction(90 days)
研究者
J. Ivan Lopez, MD
Professor of Neurology
University of Alabama at Birmingham