The Effect of PACAP38 and VIP on Migraine Patients Assessed by a 3-Tesla MR Scanner
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Comparison between PACAP38 and VIP induced changes in intracranial artery circumference before and after infusions
研究概览
简要总结
The purpose of this study is to examine and compare the effect of pituitary adenylate cyclase-activating polypeptide-38 (PACAP38) and vasoactive intestinal polypeptide (VIP) on intracranial arteries and neuronal activity in patients with migraine without aura using a high resolution magnetic resonance imaging (MRI), including MR angiography (MRA) and functional MRI (fMRI).
MRA will be used to detect changes in intracranial artery circumferences before and after PACAP38 and VIP.
fMRI will be used oo detect changes in blood-oxygenation-level-dependent-signal (BOLD-signal).
PACAP38 but not VIP induces migraine like attacks in migraine patients. The migraine specific drug sumatriptan will be given to relieve pain and the effect will also be registered using MRA and fMRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy migraine patient without aura
- •Age 18-40
- •Weight 50-100 kg
- •Fertile women must use safe contraceptives
排除标准
- •Tension type headache more than 5 days per month
- •Other primary headaches
- •Daily use of 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
- •Hypotension or hypertension
- •Cardiovascular or cerebrovascular disease
- •Mental illness or substance abuse
- •Other significant conditions determined by the examining doctor
- •Contraindications to MRI scan
- •Headache within the last 48 hours before start of trial
研究组 & 干预措施
PACAP38
干预措施: Pituitary Adenylate Cyclase-Activating Polypeptide-38 (Drug)
VIP
干预措施: Vasoactive Intestinal Peptide (Drug)
结局指标
主要结局
Comparison between PACAP38 and VIP induced changes in intracranial artery circumference before and after infusions
时间窗: Baseline, 20 minutes, 2 hours and 5 hours
次要结局
- Headache scores(24 hours)
- Comparison between PACAP38 and VIP induced changes in BOLD response(5 hours)
- Change in intracranial artery circumference before and after injection of sumatriptan(5 hours)
- Comparison between PACAP38 and VIP induced changes in brain structure(5 hours)
研究者
Faisal Mohammad Amin
medical doctor
Glostrup University Hospital, Copenhagen