The Hemodynamic Effects of CGRP After Glibenclamide Administration in a Randomized Double-blind Cross-over Placebo-controlled Study With Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Changes in the arterial radialis (RA), superficiel temporal artery (STA) and middle cerebral artery (MCA)
研究概览
简要总结
To investigate the hemodynamic effects of CGRP after glibenclamide administration.
详细描述
20 healthy participants will randomly be allocated to receive CGRP infusion followed by glibenclamide or placebo on two different days.
The aim of the study is to investigate the vascular effect of CGRP after glibenclamide administration.
Repeated measurements covering the arteria radialis (RA), superficiel temporal artery (STA) and middle cerebral artery (MCA) before and after glibenclamide/placebo administration and CGRP infusion.
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 potential must use adequate contraception
排除标准
- •A history of serious somatic disease
- •Migraine or any other type of headache (except episodic tension-type headache less than once a month)
- •Daily intake of any medication except contraceptives
研究组 & 干预措施
CGRP and glibenclamide
Participants will recieve CGRP infusion after glibenclamide/placebo administration
干预措施: glibenclamide (Drug)
CGRP and glibenclamide
Participants will recieve CGRP infusion after glibenclamide/placebo administration
干预措施: CGRP infusion (Drug)
CGRP and placebo
Participants will recieve CGRP infusion after glibenclamide/placebo administration
干预措施: CGRP infusion (Drug)
CGRP and placebo
Participants will recieve CGRP infusion after glibenclamide/placebo administration
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in the arterial radialis (RA), superficiel temporal artery (STA) and middle cerebral artery (MCA)
时间窗: Time of measurements is baseline and repeatedly every 20 min for 240 min.
Repeated measurements covering the diameter of RA , STA and MCA before and after glibenclamide/placebo administration and CGRP infusion measured by centimeter (cm)
次要结局
- Headache(Time of headache measurements is from before (-20 min) and after (12 hours) glibenclamide/placebo administration.)
研究者
Mohammad Al-Mahdi Al-Karagholi
MD, PhD student, Principal investigator
Danish Headache Center