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
- 2
- 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.
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