Adrenomedullin Effect on Migraine Without Patients

Study Overview
=================
Brief Summary
-----------------
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).

Detailed Description
-----------------
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.

Official Title
-----------------
Adrenomedullins Headache Inducing Effects on Migraine Without Patients

Conditions
-----------------
Headache, Migraine

Intervention / Treatment
-----------------
* Other: Adrenomedullin
* Other: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-60 years old 50-100 kg migraine without aura according International Headache Classification Disorders 3rd edition Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adrenomedullin<br>Will received 19.9 picomol/kg/min of adrenomedullin over 20 min | Other: Adrenomedullin<br>* Adrenomedullin is a naturally found in the human body and has strong vasoactive properties.<br>|
| Placebo Comparator: Saline<br>Saline | Other: Saline<br>* Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migraine incidance after infusion of adrenomedullin compared to placebo | A standard headache questionnaire will be used to register headache intensity and migraine associated symptoms. | 0-12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache intensity | Headache intensity will be measured using Visual analogue scale (0 = no pain -10 = worst pain ) | 0-12 hours | 
| Change in puls, MAP and facial flushing | After infusion of adrenomedullin compared to placebo | 0-90 minutes |