A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Statistically significant reduction in migraine headaches in the Rozerem treated group.
研究概览
简要总结
To study the effect of Rozerem, a high affinity MT1 and MT2, low affinity 5-HT2B receptor agonist used for insomnia, as a migraine prophylactic agent.
详细描述
In a recent, large study of migraineurs, over half reported difficulties with sleep initiation or maintenance. Those who had shorter average sleep times reported more severe headaches. Poor sleep has been associated with increased frequency and severity of migraines. The improvement of migraine frequency with improved sleep hygiene has been documented.
PET imaging has shown increased regional cerebral blood flow to neural structures involved in the sleep wake cycle during migraine headaches. Polysomnography has shown specific headache types to occur in specific sleep stages.
Melatonin has been effective primarily in headache due to delayed sleep phase syndrome. Recent studies support the efficacy of melatonin in treating migraine. The purpose of this study is to examine the efficacy of Rozerem as a prophylactic migraine medication. If effective, the benefits of the drug as a prophylactic agent for migraine include the tolerability of the drug and the possible secondary benefit of improvement in sleep.
Hypothesis
Rozerem will decrease migraine frequency due to the improvement in sleep and possibly due to the shared neurophysiology of sleep and migraine affected by melatonin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age 18-65
- •3-8 Migraine headaches/month
- •Able to understand and comply with the study
排除标准
- •Currently on migraine prophylaxis
- •Currently on sleep medication > 4days/month
- •Currently on Fluvoxamine
- •Untreated psychiatric or sleep disorders
- •MRI abnormalities other than those attributable to migraine headaches
- •Abnormalities on neurological exam other than known neurological disorders unassociated with migraine or sleep
- •Known disorders of prolactin
- •Bipolar disorder
- •Hepatic disease
- •Pregnancy
研究组 & 干预措施
1
ramelteon 8 mg po qhs with sleep and migraine journal
干预措施: ramelteon (Drug)
2
Placebo po qhs with sleep and migraine journal
干预措施: ramelteon (Drug)
结局指标
主要结局
Statistically significant reduction in migraine headaches in the Rozerem treated group.
时间窗: 4 months
次要结局
- Improvement in sleep satisfaction in the Rozerem treated group.(4 months)
研究者
Patricia Shipley, MD
Principal Investigator
Charlottesville Neuroscience