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临床试验/NCT01384812
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

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

发起方
Troels Wienecke
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Troels Wienecke

MD,PhD

Danish Headache Center

研究点 (1)

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