The Hemodynamics Effect of Levcromakalim After Glibenclamide Administration Assessed by High Resolution MRA Technique in a Randomized, Double-blind, Cross-over and Placebo-controlled Study With Healthy Volunteers.
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Changes in the middle meningeal artery (MMA), superficiel temporal artery (STA) and middle cerebral artery (MCA)
研究概览
简要总结
To investigate the effect of levcromakalim/placebo infusion on cranial arteries after glibenclamide administration.
详细描述
15 healthy participants will randomly be allocated to receive levcromakalim or placebo on to different days before and after oral glibenclamide administration.
The aim of the study is to investigate the effect of levcromakalim/placebo infusion on cranial arteries before and after glibenclamide administration.
Repeated magnetic resonance angiography (MRA) measurements covering the middle meningeal artery (MMA), superficial temporal artery (STA) and middle cerebral artery (MCA) before and after glibenclamide administration and levcromakalim/placebo 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
- •Contraindications for MRI scan.
研究组 & 干预措施
Glibenclamide and Levcromakalim
Participants will receive levcromakalim infusion after glibenclamide administration
干预措施: Levcromakalim (Drug)
Glibenclamide and Saline
Participants will receive placebo infusion after glibenclamide administration
干预措施: Saline (Drug)
Placebo
Participants will receive placebo infusion after placebo administration.
干预措施: Saline (Drug)
Levcromakalim and Glibenclamide
Participants will receive levcromakalim infusion before glibenclamide administration.
干预措施: Levcromakalim (Drug)
Levcromakalim and Placebo
Participants will receive levcromakalim infusion before placebo administration.
干预措施: Levcromakalim (Drug)
Levcromakalim and Placebo
Participants will receive levcromakalim infusion before placebo administration.
干预措施: Saline (Drug)
结局指标
主要结局
Changes in the middle meningeal artery (MMA), superficiel temporal artery (STA) and middle cerebral artery (MCA)
时间窗: Time of measurements is baseline, 1 hour after glibenclamide administration, 2 hour after glibenclamide administration, 20 minutes after levcromakalim infusion, 60 min after levcromakalim infusion
Repeated MRA measurements covering the diameter of MMA , STA and MCA before and after glibenclamide administration and levcromakalim/placebo infusion measured by centimeter (cm)
Headache
时间窗: Time of headache measurements is from before (-10 min) and after (12 hours) glibenclamide administration.
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).
Changes in Cerebral blood flow
时间窗: Time of measurements is baseline, 1 hour after glibenclamide administration, 2 hour after glibenclamide administration, 20 minutes after levcromakalim infusion, 60 min after levcromakalim infusion
Repeated MRA measurements covering the blood flow before and after glibenclamide administration and levcromakalim/placebo infusion measured by centimeter (cm)/minutes
次要结局
未报告次要终点
研究者
Mohammad Al-Mahdi Al-Karagholi
MD, PhD student
Danish Headache Center