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Adrenomedullin Effect on Migraine Without Patients

Primary Purpose

Headache, Migraine

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Adrenomedullin
Saline
Sponsored by
Danish Headache Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Headache, Migraine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Danish Headache Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Adrenomedullin

Saline

Arm Description

Will received 19.9 picomol/kg/min of adrenomedullin over 20 min

Saline

Outcomes

Primary Outcome Measures

Migraine incidance after infusion of adrenomedullin compared to placebo
A standard headache questionnaire will be used to register headache intensity and migraine associated symptoms.

Secondary Outcome Measures

Headache intensity
Headache intensity will be measured using Visual analogue scale (0 = no pain -10 = worst pain )
Change in puls, MAP and facial flushing
After infusion of adrenomedullin compared to placebo

Full Information

First Posted
September 26, 2019
Last Updated
February 28, 2020
Sponsor
Danish Headache Center
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1. Study Identification

Unique Protocol Identification Number
NCT04111484
Brief Title
Adrenomedullin Effect on Migraine Without Patients
Official Title
Adrenomedullins Headache Inducing Effects on Migraine Without Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 28, 2019 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Migraine

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Masking Description
Study participants and investigator will be blinded.
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adrenomedullin
Arm Type
Active Comparator
Arm Description
Will received 19.9 picomol/kg/min of adrenomedullin over 20 min
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Saline
Intervention Type
Other
Intervention Name(s)
Adrenomedullin
Intervention Description
Adrenomedullin is a naturally found in the human body and has strong vasoactive properties.
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Migraine incidance after infusion of adrenomedullin compared to placebo
Description
A standard headache questionnaire will be used to register headache intensity and migraine associated symptoms.
Time Frame
0-12 hours
Secondary Outcome Measure Information:
Title
Headache intensity
Description
Headache intensity will be measured using Visual analogue scale (0 = no pain -10 = worst pain )
Time Frame
0-12 hours
Title
Change in puls, MAP and facial flushing
Description
After infusion of adrenomedullin compared to placebo
Time Frame
0-90 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Danish Headache Center
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33827963
Citation
Ghanizada H, Al-Karagholi MA, Arngrim N, Morch-Rasmussen M, Walker CS, Hay DL, Ashina M. Effect of Adrenomedullin on Migraine-Like Attacks in Patients With Migraine: A Randomized Crossover Study. Neurology. 2021 May 18;96(20):e2488-e2499. doi: 10.1212/WNL.0000000000011930. Epub 2021 Apr 7.
Results Reference
derived

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Adrenomedullin Effect on Migraine Without Patients

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