NCT01488110终止不适用
Undersökning av ny Behandlingsmetod Vid migränanfall (Evaluation of a New Treatment for Migraine Attacks)
Karolinska University Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from baseline in pain intensity according to VAS-scales (0-10)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of a novel therapy for treatment of migraine, pain reduction and relief of associated symptoms during ongoing migraine attacks, and presence of a preventive effect two months post treatment. Another purpose is to investigate if and how this treatment affects manifestations of the autonomic nervous system activity.
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
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male subjects, in otherwise good health, 20 to 55 years of age
- •Subjects who meet the ICHD-2 (2nd Edition of The International Headache Classification) criteria for migraine headache
- •Subjects with a minimum of 1 migraine attack per month
- •Attack duration of 4 to 72 hours
- •Normal attack intensity of at least 4 on a 0-10 VAS-scale
排除标准
- •Completed heart surgery
- •Cardiovascular diseases
- •Vascular damages on neck vessels
- •Diseases other than migraine of the CNS
- •Severe disease of vital body organs
- •Severe psychiatric disorders
- •More than 6 migraine attacks per month
结局指标
主要结局
Change from baseline in pain intensity according to VAS-scales (0-10)
时间窗: Estimation 40 minutes
Documentation of pain intensity prior to treatment initiation (baseline value), every 5 minutes during treatment and post treatment.
次要结局
- RR (Heart rate)-interval(Estimation 40 minutes)
- Change from baseline in sympathetic nervous system activity(Estimation 40 minutes)
- Blood pressure(Estimation 40 minutes)
- Change from baseline in attack frequency based on completed patient diaries(3 to 4 months)
- Change from baseline in attack intensity based on completed patient diaries(3 to 4 months)
- Change from baseline in attack duration based on completed patient diaries(3 to 4 months)
- Change from baseline in medicine consumption based on completed patient diaries(3 to 4 months)
研究者
Jan-Erik Juto
Adjunct professor
Karolinska University Hospital
研究点 (2)
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