The Effect of PACAP27 on the Extra- and Intracerebral Arteries Assessed by MRA on Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Dilation of extra- and intracerebral arteries
研究概览
简要总结
Studying Pituitary adenylate cyclase-activating peptide 27 (PACAP27) effects on extra- and intracerebral arteries assessed by MRA on healthy volunteers.
详细描述
PACAP neuropeptide, which belongs to the vasoactive intestinal polypeptide (VIP)/glucagon/secretin family. PACAP exists in two forms: Studying Pituitary adenylate cyclase-activating peptide 38 (PACAP38), which consists of 38 amino acids and PACAP27 which contains 27 amino acids at its N-terminus. PACAP38 is implicated in migraine pathophysiology however PACAP27 is not studied well. Therefore, the investigators will study PACAP27's effect on extra- and intracerebral arteries assessed by MRA on healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Randomized, double-blind placebo-controlled design in healthy volunteers.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Aged 18-50
- •50-100 kg
排除标准
- •Tension type headache more than 5 dag /month
- •Other primary headaches
- •Daily medication except contraceptives
- •Drug taken within 4 times the half-life for the specific drug except contraceptives
- •Pregnant or lactating women
- •Exposure to radiation within the last year
- •Headache within the last 24 hours before start of trial
- •Hypertension
- •Hypotension
- •Respiratory or cardiac disease
- •Primary relatives with current or previous migraine
研究组 & 干预措施
PACAP27
12 healthy volunteers will receive PACAP27 (10 picomole/kg/min) over 20 min
干预措施: PACAP27 (Other)
Placebo
6 healthy volunteers will receive placebo (Saline) over 20 min
干预措施: Placebo (Other)
结局指标
主要结局
Dilation of extra- and intracerebral arteries
时间窗: 0-290 min
A single-slab 3D time-of-flight (3D TOF) MRA of extra- and intracranial arteries will be acquired as described in previous studies (Amin et al., 2013, 2014). MRA data will be analyzed by LKEB-MRA vessel wall analysis software program. We will measure the circumference of vessels in millimeter in five predefined time points (0, 20, 110, 200 and 290 min)
次要结局
- Headache(0 to 24 hours)
研究者
Hashmat Ghanizada
Principal Investigator
Danish Headache Center