Phase III Double Blind Randomized Placebo Controlled Trial Using 20% Intra-Oral Ketoprofen Gel for Migraine Prevention.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Change in number of migraine days per month
研究概览
简要总结
Intra-Oral Topical Ketoprofen gel, applied to a branch of the trigeminal nerve, has been shown to prevent migraines when used once daily for 3 months in open label studies. This is a randomized, double-blind, placebo controlled phase III prevention trial to determine safety and efficacy.
详细描述
This is a 4 month trial. During the first month, a prospective headache diary is maintained. Migraine frequency, severity (1-10), duration, and all headache medications are recorded.
Patients are then randomized to receive active gel or placebo gel in double blind fashion.
Gel is applied to the posterior maxilla once daily for 3 months. A daily headache diary, as outlined above, is maintained throughout the trial. Patients may continue to take other migraine medications, as needed. No other new migraine therapies may be started during the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •IHS Migraine with or without aura
- •18 y.o. or older
- •at least 4 migraines per month
排除标准
- •pregnancy
- •other headache conditions
- •chronic daily headache
- •allergy or sensitivity to NSAIDs other severe illnesses
研究组 & 干预措施
Topical Ketoprofen gel
干预措施: topical intraoral ketoprofen gel (Drug)
Placebo gel
干预措施: Placebo Gel (Other)
结局指标
主要结局
Change in number of migraine days per month
时间窗: 3 months
Number of migraine days per month will be compared before gel use and at the end of 3 months of use.
次要结局
- Change in migraine severity(3 month total)
- Change in migraine duration(3 months)
- Change in headache medication use(3 months)