The Hemodynamic Effects of CGRP After Glibenclamide Administration in Healthy Volunteers

Danish Headache Center

Status: Completed

Conditions: Cerebral Blood Flow; Hemodynamics of Cranial Arteries; Headache

Treatments: Drug: CGRP infusion; Drug: Placebo; Drug: glibenclamide

Study type: Interventional

Funder types: Other

Identifiers

NCT04231617

H-19065735

Details and patient eligibility

About

To investigate the hemodynamic effects of CGRP after glibenclamide administration.

Full description

20 healthy participants will randomly be allocated to receive CGRP infusion followed by glibenclamide or placebo on two different days.

The aim of the study is to investigate the vascular effect of CGRP after glibenclamide administration.

Repeated measurements covering the arteria radialis (RA), superficiel temporal artery (STA) and middle cerebral artery (MCA) before and after glibenclamide/placebo administration and CGRP infusion.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers of both sexes.
• 18-60 years.
• 50-100 kg.
• Women of childbearing potential must use adequate contraception

Exclusion criteria

• A history of serious somatic disease
• Migraine or any other type of headache (except episodic tension-type headache less than once a month)
• Daily intake of any medication except contraceptives

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

CGRP and glibenclamide

Active Comparator group

Description:

Participants will recieve CGRP infusion after glibenclamide/placebo administration

Treatment:

Drug: CGRP infusion

Drug: glibenclamide

CGRP and placebo

Active Comparator group

Description:

Participants will recieve CGRP infusion after glibenclamide/placebo administration

Treatment:

Drug: CGRP infusion

Drug: Placebo