NCT01384812已完成不适用
Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of Prostaglandin E2 in Migraine Suffers Without Aura.
Troels Wienecke1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2010年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Headache score on a 10-point verbal rating scale (VRS).
研究概览
简要总结
The hypothesis of this study is that Prostaglandin E2 (PGE2) induces headache and dilatation of brain vessels in migraine patients without aura.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with migraine without aura
排除标准
- •Tension type headache more than x 3 per month
- •Other forms for primary headache
- •Headache 24 h before the day of the investigation
- •Migraine 48 h before the day of the investigation
- •Hypertension
- •Hypotension
- •Pregnant/nursing
- •Daily intake of medication (except oral contraceptives and migraine rescue medicine during migraine attack)
- •Cardiovascular or central nervous system (CNS) disease
- •Drug/alcohol abuse
- •Psychiatric disease
- •Asthma or any other lung diseases
研究组 & 干预措施
Isoton sodium chloride
Placebo Comparator
干预措施: isoton sodium chloride (Drug)
Prostin E2 (dinoprostone)
Active Comparator
干预措施: dinoprostone (Drug)
结局指标
主要结局
Headache score on a 10-point verbal rating scale (VRS).
时间窗: 24 h
Incidence of headache 0 indicated no headache; 1 indicated a different sensation, pounding or throbbing, but not necessarily painful; 5 indicated moderate headache and 10 indicated worst imaginable headache.
次要结局
- Blood flow velocity in the middle cerebral artery (VMCA) measured by a Transcranial Doppler (TCD) ultrasonography (2MHz).(90 min)
- Diameter of superficial temporal artery and radial artery measured by a high resolution ultrasound scanner, C-scan.(90 min)
- Mean arterial blood pressure (MAP).(90 min)
- Electrocardiography (ECG).(90 min)
- Heart rate (HR).(90 min)
- End-tidal partial pressure of pCO2 (PetCO2).(90 min)
- Transcutaneous arterial oxygen saturation (SAT)(90 min)
研究者
Troels Wienecke
MD,PhD
Danish Headache Center
研究点 (1)
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