Skip to main content
OpenTrials
Completed

NCT Number: NCT04111484

Adrenomedullin Effect on Migraine Without Patients

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Headache Center

Glostrup Municipality, 2600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adrenomedullin

Other

Adrenomedullin is a naturally found in the human body and has strong vasoactive properties.

Saline

Other

Placebo

Primary outcomes

  1. Migraine incidance after infusion of adrenomedullin compared to placebo

    Time frame: 0-12 hours

    A standard headache questionnaire will be used to register headache intensity and migraine associated symptoms.

Secondary outcomes

  1. Headache intensity

    Time frame: 0-12 hours

    Headache intensity will be measured using Visual analogue scale (0 = no pain -10 = worst pain )

  2. Change in puls, MAP and facial flushing

    Time frame: 0-90 minutes

    After infusion of adrenomedullin compared to placebo

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Official study title

Adrenomedullins Headache Inducing Effects on Migraine Without Patients

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 1, 2019
Registry last updated
Mar 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.