Adrenomedullin Effect on Migraine Without Patients

February 28, 2020 updated by: Hashmat Ghanizada, MD, Danish Headache Center

Adrenomedullins Headache Inducing Effects 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup, Denmark, 2600
        • Danish Headache Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0-12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Headache intensity
Time Frame: 0-12 hours
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
Time Frame: 0-90 minutes
After infusion of adrenomedullin compared to placebo
0-90 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Headache Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2019

Primary Completion (Actual)

January 30, 2020

Study Completion (Actual)

January 30, 2020

Study Registration Dates

First Submitted

September 26, 2019

First Submitted That Met QC Criteria

September 30, 2019

First Posted (Actual)

October 1, 2019

Study Record Updates

Last Update Posted (Actual)

March 2, 2020

Last Update Submitted That Met QC Criteria

February 28, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-18020494

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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