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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

Tracking Information
First Submitted Date  ICMJE September 26, 2019
First Posted Date  ICMJE October 1, 2019
Last Update Posted Date March 2, 2020
Actual Study Start Date  ICMJE September 28, 2019
Actual Primary Completion Date January 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2019)
  • Headache intensity [ Time Frame: 0-12 hours ]
    Headache intensity will be measured using Visual analogue scale (0 = no pain -10 = worst pain )
  • Change in puls, MAP and facial flushing [ Time Frame: 0-90 minutes ]
    After infusion of adrenomedullin compared to placebo
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adrenomedullin Effect on Migraine Without Patients
Official Title  ICMJE Adrenomedullins Headache Inducing Effects on Migraine Without Patients
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Study participants and investigator will be blinded.
Primary Purpose: Other
Condition  ICMJE Headache, Migraine
Intervention  ICMJE
  • Other: Adrenomedullin
    Adrenomedullin is a naturally found in the human body and has strong vasoactive properties.
  • Other: Saline
    Placebo
Study Arms  ICMJE
  • Active Comparator: Adrenomedullin
    Will received 19.9 picomol/kg/min of adrenomedullin over 20 min
    Intervention: Other: Adrenomedullin
  • Placebo Comparator: Saline
    Saline
    Intervention: Other: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 30, 2019)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 30, 2020
Actual Primary Completion Date January 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04111484
Other Study ID Numbers  ICMJE H-18020494
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hashmat Ghanizada, MD, Danish Headache Center
Study Sponsor  ICMJE Danish Headache Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Danish Headache Center
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP