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

Headache, Migraine Clinical Trial

Official title:

Investigation of Vasodilation and Intensity of Headache Triggered by Glucagon-like Peptide-1 in Healthy Volunteers and Migraine Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04232605
• Other study ID #: H-19037051
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: January 2020
• Source: Danish Headache Center
• Contact: Hashmat Ghanizada, MD
• Phone: 38633470
• Email: hashmat.ghanizada[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. completion date: January 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Headache, Migraine
• Migraine Disorders

Intervention

Other:
• GLP-1 peptide
Receive intravenous infusion of GLP-1. The dosage will be determined after a dose finding pilot study.
• Placebo
Receive intravenous infusion saline

Locations

Country	Name	City	State
Denmark	Dansk Hovedpinecenter	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vasodilation	Difference in circumference (in millimeter) of intra - and extracranial blood vessels before and after GLP-1 or placebo infusion, measured by transcranial doppler and ultrasound (Derma scan) at 10 specific time points (-10, 10, 20, 30, 40, 50, 60, 80, 100, and 120 minutes)	120 minutes
Primary	Headache intensity	Headache intensity will be measured using Numerical rating scale (NRS) from ( 0 to 10 )	12 hours
Secondary	blood pressure	Blood pressure (systolic and diastolic) in mmhg will be measured every 10 minutes	120 minutes
Secondary	Facial skin perfusion	Non-invasive measuring of facial skin perfusion by laser speckle contrast imager.	120 minutes
Secondary	Heart rate	heart rate will be measured every 10 minutes	120 minutes
Secondary	Plasma glucose	Plasma glucose will be measured using (mmol/L) a ABL Radiometer, Denmark Blood-gas analyser	120 minutes