NCT00849511已完成2 期
Melatonin for Migraine Prevention (The MMP-study): A Randomized, Double-blind, Cross-over, Placebo-controlled Study of Melatonin in Prophylactic Treatment of Migraine
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Migraine attack frequency
研究概览
简要总结
The circadian system with its centre in the hypothalamus is involved in migraine pathophysiology. Whether it plays a pivotal role is not clarified. The investigators postulate that a destabilized circadian system may increase migraine attack susceptibility, and that stabilization by supplying melatonin a migraine preventive effect will be achieved.
A previous open label study has shown effects that certainly warrant a placebo controlled study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, 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
- 是
入选标准
- •Patients between 18 and 65 years, both male and females.
- •Migraine present for at least 1 year and fulfilling diagnostic criteria that conform to those of the International Headache Society (HIS) [2] but otherwise healthy.
- •Attacks of migraine should occur 4-6 times per month, there should be no regular use of other drugs, and the patient has to be able to differentiate between migraine headache and non-migrainous headache.
- •Preventive drugs for migraine should not have been used the last three months.
- •Conventional acute attack treatment is accepted, but not sporadic use of other drugs like hypnotics and anxiolytics.
- •Residence of North-Norway.
排除标准
- •Medication overuse headache, chronic migraine.
- •Pregnant and breast feeding women.
- •Patient with either serious co-morbidity or conditions requiring medical treatment or caution.
- •Psychiatric disease.
研究组 & 干预措施
Placebo first
Active Comparator
Placebo 8 weeks, 6 weeks washout, extended-release melatonin 2 mg vesper for 8 weeks
干预措施: melatonin (Drug)
Melatonin first
Active Comparator
Extended-release melatonin 2 mg vesper for 8 weeks, 6 weeks washout, placebo 8 weeks
干预措施: melatonin (Drug)
结局指标
主要结局
Migraine attack frequency
时间窗: 8 weeks
次要结局
- Night time sleep quality(8 weeks)
- Pittsburgh Sleep Quality Index score(8 weeks)
- Point prevalence of insomnia(8 weeks)
研究者
Karl B. Alstadhaug
MD, PhD
Nordlandssykehuset HF
研究点 (2)
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