Adrenomedullins Headache Inducing Effects on Migraine Without Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Migraine incidance after infusion of adrenomedullin compared to placebo
研究概览
简要总结
AM is a naturally occurring peptide in the body and consists of 52 amino acids. AM belongs to the calcitonin gene-related peptide (CGRP) superfamily and has several structural, physiological and pharmacological similarities to CGRP, intermdine and amylin. In a randomized double-blind, placebo controlled cross-over design 20 migraine patients without aura recruited to receive infusion of adrenomedullin or placebo (saline).
详细描述
AM is a naturally occurring peptide in the body and consists of 52 amino acids. AM belongs to the calcitonin gene-related peptide (CGRP) superfamily and has several structural, physiological and pharmacological similarities to CGRP, intermdine and amylin. In a randomized double-blind, placebo controlled cross-over design 20 migraine patients without aura recruited to receive infusion of adrenomedullin or placebo (saline).
A pilot study on healthy volunteers were conducted to determine tolerable dose of adrenomedullin to the main study.
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
- Double (Participant, Investigator)
盲法说明
Study participants and investigator will be blinded.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-60 years old
- •50-100 kg
- •migraine without aura according International Headache Classification Disorders 3rd edition
排除标准
- •Tension-type headaches more than 5 days a month on average over the past year.
- •All other primary headache forms.-
- •Headache later than 48 hours before the start of the trial.
- •Daily intake of medicines of all kinds except oral contraception.
- •Taking any medicine later than 4 times the plasma half-life of that drug (on the day of the trial), except oral contraception.
- •Pregnant or breastfeeding women.
- •Headache on the day of the trial or later than 48 hours before the administration of the trial drug / placebo
- •Migraines within 3 days before the trial date.
- •Anamnestic information or clinical signs (on the day of inclusion):
- •Hypertension (systolic blood pressure> 150 mmHg and / or diastolic blood pressure> 100 mmHg)
- •Hypotension (systolic blood pressure <90 mm Hg and / or diastolic blood pressure <50 mmHg)
- •Cardiovascular diseases of all kinds, including cerebrovascular diseases.
- •Anamnestic or clinical signs of mental illness or abuse.
- •Patients with glaucoma or prostate hyperplasia
- •Anamnestic or clinical signs of illness of any kind that the investigating physician considers relevant for participation in the trial.
研究组 & 干预措施
Saline
Saline
干预措施: Saline (Other)
Adrenomedullin
Will received 19.9 picomol/kg/min of adrenomedullin over 20 min
干预措施: Adrenomedullin (Other)
结局指标
主要结局
Migraine incidance after infusion of adrenomedullin compared to placebo
时间窗: 0-12 hours
A standard headache questionnaire will be used to register headache intensity and migraine associated symptoms.
次要结局
- Change in puls, MAP and facial flushing(0-90 minutes)
- Headache intensity(0-12 hours)
研究者
Hashmat Ghanizada, MD
MD, PhD-Fellow
Danish Headache Center