Clinical trial NCT04232605: Investigation of Vasodilation and Intensity of Headache Triggered by Glucagon Like Peptide-1 in Humans
Official title: Investigation of Vasodilation and Intensity of Headache Triggered by Glucagon-like Peptide-1 in Healthy Volunteers and Migraine Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Headache, Migraine
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Phase one: In a randomized, single-blind, multiple-ascending-dose finding pilot study we investigate the safety and tolerability of GLP-1 on three healthy volunteers. The following GLP-1 doses will be given intravenously ( 1.5, 2.0 and 2.5 picomol/kg/min) over 20 min. The dose with considerable dilatory effect will be chosen for main study.

Phase 2 and 3:The study is a double-blinded, placebo-controlled, randomized crossover study. It involves two arms, GLP-1 and placebo. Each participant will in a randomized order receive placebo or GLP-1 intravenous infusion over 20 min on the two experiment days.

The study consists of two separate substudies, one for healthy volunteers and one for migraine patients. The substudies are otherwise identical.
Primary purpose: OTHER

Brief summary: Studying glucagon-like peptide-1 (GLP-1) induced vasodilatory effects on extra - and intracerebral arteries and headache in healthy volunteers and migraine patients without aura.

Detailed description: The purpose of this study is to examine the association between vasodilation and intensity of headache triggered by glucagon-like peptide 1 (GLP-1) in healthy volunteers and migraine patients without aura.

Eligibility criteria: Criteria for the healthy volunteers group

Inclusion Criteria:

* Healthy men/women.
* Age 18 to 60 years old.
* Weight 50 to 100 kg.

Exclusion Criteria:

* Tension headache more than 5 days a month in the preceding year.
* All other primary headache types.
* Headache on the examination day or within 48 hours before infusion of the study drug.
* Smoking.
* Daily intake of medicine of any kind except for peroral contraceptives.
* Women, who on the day of examination is 2 days before or 3 days from the first day of bleeding.
* Hypertension or hypotension.
* Coronary heart disease of any kind, as well as cerebrovascular disease.
* Pulmonary disease.
* Allergy to contents in the study drug.
* Psychiatric disease or substance abuse.
* Disease of any kind which the examining doctor deems relevant for participation in the study.
* Renouncing the right to information concerning own health.

Criteria for the migraine patients group

Inclusion Criteria:

* Migraine patients, who fulfill the ICHD-3 criteria for migraine without aura.
* Age 18 to 60 years old.
* Weight 50 to 100 kg.

Exclusion Criteria:

* Tension headache more than 5 days a month in the preceding year.
* All other primary headache types.
* Headache on the examination day or within 48 hours before infusion of the study drug.
* Smoking.
* Daily intake of medicine of any kind except for peroral contraceptives.
* Women, who on the day of examination is 2 days before or 3 days from the first day of bleeding.
* Hypertension or hypotension.
* Coronary heart disease of any kind, as well as cerebrovascular disease.
* Pulmonary disease.
* Allergy to contents in the study drug.
* Psychiatric disease or substance abuse.
* Disease of any kind which the examining doctor deems relevant for participation in the study.
* Renouncing the right to information concerning own health.

Primary outcomes:
measure: Vasodilation
timeFrame: 120 minutes
measure: Headache intensity
timeFrame: 12 hours
Secondary outcomes:
measure: blood pressure
timeFrame: 120 minutes
measure: Facial skin perfusion
timeFrame: 120 minutes
measure: Heart rate
timeFrame: 120 minutes
measure: Plasma glucose
timeFrame: 120 minutes
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Dansk Hovedpinecenter
Study officials:
References: