Adrenomedullin Effect on Migraine Without Patients

Not Applicable

Completed

• Conditions: Headache, Migraine
• Interventions: Other: Saline; Other: Adrenomedullin

• Registration Number: NCT04111484
• Lead Sponsor: Danish Headache Center

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.

Study Timeline

• Study First Submitted: 2019-09-26
• Study Start: 2019-09-28
• Study First Submitted QC: 2019-09-30
• Study First Posted: 2019-10-01
• Primary Completion: 2020-01-30
• Study Completion: 2020-01-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-28
• Last Update Posted: 2020-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Saline	Saline	Saline
Adrenomedullin	Adrenomedullin	Will received 19.9 picomol/kg/min of adrenomedullin over 20 min

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Danish Headache Center; 🇩🇰 Glostrup, Denmark