A Phase IIa Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Bimatoprost in the Treatment of Migraine
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Reduction in Headache Frequency
研究概览
简要总结
The study is to assess the effectiveness of topically applied bimatoprost in reducing migraine headache frequency, severity, and duration. It will also assess the effect of topical bimatoprost on quality of life.
详细描述
Hall, et al. have observed retrospectively that treatment with topical prostaglandin F2 alpha analogs (applied either to the eye or fingernail bed) significantly reduced the frequency, severity and duration of headaches in migraine sufferers, as well as their migraine disability assessment score (MIDAS).
This is a double-blind, placebo-controlled prospective clinical study to determine if the effect of FDA-approved bimatoprost, a prostaglandin F2 alpha analogue, has anti-migraine activity when administered topically to people suffering from migraine.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of migraines based on International Classification of Headache Disorders (ICHD) II criteria and experiencing headaches for 4 or more days per month.
排除标准
- •Significant liver or renal dysfunction,
- •On treatment for inflammatory bowel disease, medication over-use for headaches according to the ICHD II criteria,
- •Use of antipsychotics in the past month,
- •Recent (in the past six months) history of alcohol or drug abuse,
- •Allergy to bimatoprost and its compounds,
- •Severe comorbid psychiatric illness,
- •Severe infection,
- •Malignancy,
- •Severe cardiovascular disease,
- •Neurodegenerative disorders,
- •Pregnancy and lactation, and
- •Sexually active women of child bearing age who do not use any method of contraception.
研究组 & 干预措施
Bimatoprost Topical Solution
0.03% bimatoprost topical solution applied daily to the nail bed of fingers on one hand for 12 weeks
干预措施: Bimatoprost Topical Solution (Drug)
Control
Saline placebo topically applied daily to the nail be of fingers on one hand for 12 weeks
干预措施: Control (Drug)
结局指标
主要结局
Reduction in Headache Frequency
时间窗: 12 weeks
Change from baseline in the average number of headache days per month
次要结局
- Intensity of Headaches(12 weeks)
- Duration of Headaches(12 weeks)
- Migraine Disability Assessment Scale (MIDAS)--Quality of Life(12 weeks)