The Effect of Intravenous L-kynurenine (LKYN) on Cerebral Hemodynamics in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Velocity of MCA (VMCA)
研究概览
简要总结
To measure the cerebral hemodynamic effect of L-kynurenine.
详细描述
Aim: To investigate the physiological effect of L-Kynurenine after intravenous administration to healthy volunteers.
Hypothesis
L-kynurenine induces vasodilation in the cerebral vessels and trigger headache in healthy individuals.
Methods: 6 healthy volunteers will receive intravenous infusion of L-kynurenine using the following doses 50 microgram/kg, 100 microgram/kg, 150 microgram/kg, 300 microgram/kg, 500 microgram/kg, 1 mg/kg and 5 mg/kg over 20 min on 7 different days with at least 1 day in between. Before and after infusion (at 20, 40, 60, 80 and 100 min) we will record vital signs, circumferences of middle cerebral artery, superficial temporalis artery and headache intensity and characteristics.
The subjects will then have a questionnaire about headache for the following 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
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.
- •Women of childbearing potential must use adequate contraception.
排除标准
- •All primary headaches
- •First-degree relative with migraine
- •Headache less than 48 hours before the tests start
- •Daily consumption of drugs of any kind other than oral contraceptives.
- •Pregnant or nursing women. Cardiovascular disease of any kind, including cerebrovascular diseases.
结局指标
主要结局
Velocity of MCA (VMCA)
时间窗: Change from baseline VMCA at two hours after administration of L-kynurenine
Measured in MCA (middle cerebral artery) bilaterally with ultrasound (TCD) (2 Mhz, DWL)
Headache
时间窗: occurrence of headache undtil 24 hours after infusion.
Headache declared orally on a verbal rating scale (VRS) 0-10. 0 represents no pain and 10 the worst possible headache.
The diameter of the STA (superficial temporal artery)
时间窗: Change from baseline VMCA at two hours after administration of L-kynurenine
Measured by high-frequency ultrasound 12 of 29 (Derma Scan C, Cortex Technology, Denmark)
次要结局
未报告次要终点
研究者
Mohammad Al-Mahdi Al-Karagholi
MD, PhD student, Principal investigator
Danish Headache Center