A Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, and Safety of Oral Frovatriptan in the Prevention on Menstrually-related Migraine (MRM) Headaches in a 'Difficult to Treat' Population
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 主要终点
- Primary endpoint Number of MRM headache free PMPs out of a potential of three treated PMPs
研究概览
简要总结
Although the predictability of an MRM headache attack lends itself to preventative treatment, there are currently no drugs specifically indicated for the prevention of MM. Such preventative therapies might be administered either short term (during the time around the period otherwise known as the peri-menstrual period or PMP) or continuously throughout the menstrual cycle.
Frovatriptan has been developed for the management of migraine and is already licensed for use as an acute treatment for this condition. Previous well controlled clinical trials have highlighted the potential of frovatriptan as a short-term preventative medication for MM. This clinical trial was meant to further explore this indication for frovatriptan in an expanded population.
详细描述
See above
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre-menopausal females diagnosed as suffering from MRM aged 15 years and over, that fit the criteria for 'difficult to treat'
排除标准
- 未提供
结局指标
主要结局
Primary endpoint Number of MRM headache free PMPs out of a potential of three treated PMPs
次要结局
- Incidence of MRM headache
- Maximum headache intensity
- Incidence of moderate or severe MRM headaches
- Number of MRM headache free days during treated PMPs
- Incidence of MRM headache associated symptoms (e.g. photophobia, phonophobia, nausea and vomiting)
- Functional impairment during treatment phase
- Time to onset (days) of MRM headache (during the treated PMP and until five days post treatment)
- Time to onset of first post-treatment migraine Incidence of intercurrent migraine outside of the peri-menstrual period Use of rescue medication