Adrenomedullin Effect on Migraine Without Patients

Danish Headache Center

Status: Completed

Conditions: Headache, Migraine

Treatments: Other: Adrenomedullin; Other: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04111484

H-18020494

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Adrenomedullin

Active Comparator group

Description:

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

Treatment:

Other: Adrenomedullin

Saline

Placebo Comparator group

Description:

Saline

Treatment:

Other: Saline