Investigation of Vasodilation and Intensity of Headache Triggered by Glucagon Like Peptide-1 in Humans

Danish Headache Center

Status: Unknown

Conditions: Headache, Migraine

Treatments: Other: GLP-1 peptide; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04232605

H-19037051

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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43 participants in 2 patient groups, including a placebo group

GLP-1

Active Comparator group

Description:

Receive intravenous infusion of GLP-1.

Treatment:

Other: GLP-1 peptide

Placebo

Placebo Comparator group

Description:

Receive intravenous infusion of saline.

Treatment:

Other: Placebo