Clinical trial NCT04111484: Adrenomedullin Effect on Migraine Without Patients
Official title: Adrenomedullins Headache Inducing Effects on Migraine Without Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache, Migraine
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Migraine incidance after infusion of adrenomedullin compared to placebo
timeFrame: 0-12 hours
Secondary outcomes:
measure: Headache intensity
timeFrame: 0-12 hours
measure: Change in puls, MAP and facial flushing
timeFrame: 0-90 minutes
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center
Study officials:
References:
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.