Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Adrenomedullin Effect on Migraine Without Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04111484
Recruitment Status : Completed
First Posted : October 1, 2019
Last Update Posted : March 2, 2020
Sponsor:
Information provided by (Responsible Party):
Hashmat Ghanizada, MD, 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).

Condition or disease Intervention/treatment Phase
Headache, Migraine Other: Adrenomedullin Other: Saline Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description: Study participants and investigator will be blinded.
Primary Purpose: Other
Official Title: Adrenomedullins Headache Inducing Effects on Migraine Without Patients
Actual Study Start Date : September 28, 2019
Actual Primary Completion Date : January 30, 2020
Actual Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
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.

Placebo Comparator: Saline
Saline
Other: Saline
Placebo




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111484


Locations
Layout table for location information
Denmark
Danish Headache Center
Glostrup, Denmark, 2600
Sponsors and Collaborators
Danish Headache Center
Layout table for additonal information
Responsible Party: Hashmat Ghanizada, MD, MD, PhD-Fellow, Danish Headache Center
ClinicalTrials.gov Identifier: NCT04111484    
Other Study ID Numbers: H-18020494
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: March 2, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Adrenomedullin
Antihypertensive Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cardiotonic Agents
Vasodilator Agents
Protective Agents