Adrenomedullin Effect on Migraine Without Patients

Headache, Migraine Clinical Trial

Official title:

Adrenomedullins Headache Inducing Effects on Migraine Without Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04111484
• Other study ID #: H-18020494
• Status: Completed
• Phase: N/A
• Start date: September 28, 2019
• Est. completion date: January 30, 2020

Study information

• Verified date: February 2020
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Headache, Migraine
• Migraine Disorders

Intervention

Other:
• Adrenomedullin
Adrenomedullin is a naturally found in the human body and has strong vasoactive properties.
• Saline
Placebo

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

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