The Hemodynamic Effects of PACAP38 After Glibenclamide Administration in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Headache
研究概览
简要总结
To investigate the hemodynamic effects of PACAP38 after glibenclamide administration.
详细描述
22 healthy participants will randomly be allocated to receive PACAP38 infusion followed by glibenclamide or placebo on two different days.
The aim of the study is to investigate the vascular effect of PACAP38 after glibenclamide administration.
Repeated measurements covering the arteria radialis (RA), superficial temporal artery (STA) and middle cerebral artery (MCA) before and after PACAP38 infusion and glibenclamide/placebo administration
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers of both sexes.
- •18-60 years.
- •50-100 kg.
- •Women of childbearing age must use adequate contraception
排除标准
- •A history of serious somatic or psychiatric disease
- •Migraine or any other type of headache (except episodic tension-type headache less than 5 days per month)
- •Daily intake of any medication except contraceptives
研究组 & 干预措施
PACAP38 and glibenclamide
Participants will receive glibenclamide after PACAP38 infusion
干预措施: glibenclamide (Drug)
PACAP38 and glibenclamide
Participants will receive glibenclamide after PACAP38 infusion
干预措施: PACAP38 (Drug)
PACAP38 and placebo
Participants will receive placebo after PACAP38 infusion
干预措施: glibenclamide (Drug)
PACAP38 and placebo
Participants will receive placebo after PACAP38 infusion
干预措施: PACAP38 (Drug)
结局指标
主要结局
Headache
时间窗: Time of headache measurements is from before (-20 minutes) and up to 12 hours after PACAP38 infusion
Headache intensity will be recorded by numerical rating scale (NRS) from 0 to 10 (0, no headache; 1, a feeling of pressure; 10, worst imaginable headache).
次要结局
- Changes in the arterial radialis (RA), superficial temporal artery (STA) and middle cerebral artery (MCA).(Time of measurements is baseline and repeatedly every 20 minutes for 260 minutes.)
研究者
Lili Kokoti
MD, PhD student, Principal investigator
Danish Headache Center