Adrenomedullin Effect on Migraine Without Patients

NCT ID: NCT04111484

Last Updated: 2020-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-28

Study Completion Date

2020-01-30

Brief Summary

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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

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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.

Conditions

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Headache, Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
Study participants and investigator will be blinded.

Study Groups

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Adrenomedullin

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

Group Type ACTIVE_COMPARATOR

Adrenomedullin

Intervention Type OTHER

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

Saline

Saline

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

Placebo

Interventions

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Adrenomedullin

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

Intervention Type OTHER

Saline

Placebo

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Headache Center

OTHER

Sponsor Role lead

Responsible Party

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Hashmat Ghanizada, MD

MD, PhD-Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Danish Headache Center

Glostrup Municipality, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 33827963 (View on PubMed)

Other Identifiers

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H-18020494

Identifier Type: -

Identifier Source: org_study_id

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