The Hemodynamic Effects of CGRP After Glibenclamide Administration in Healthy Volunteers

The Hemodynamic Effects of CGRP After Glibenclamide Administration in a Randomized Double-blind Cross-over Placebo-controlled Study With Healthy Volunteers

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04231617

Enrollment

Registered

2020-01-18

Start date

2020-01-20

Completion date

2020-09-01

Last updated

2020-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Blood Flow, Headache, Hemodynamics of Cranial Arteries

Brief summary

To investigate the hemodynamic effects of CGRP after glibenclamide administration.

Detailed 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.

Interventions

DRUGPlacebo

placebo

DRUGglibenclamide

Oral administration of glibenclamide or placebo. To investigate the role of CGRP on cranial arteries in healthy volunteers after glibenclamide/placebo administration .

DRUGCGRP infusion

CGRP infusion

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Randomized, double-blind, cross-over, placebo-controlled design in healthy volunteers.

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Changes in the arterial radialis (RA), superficiel temporal artery (STA) and middle cerebral artery (MCA)	Time of measurements is baseline and repeatedly every 20 min for 240 min.	Repeated measurements covering the diameter of RA , STA and MCA before and after glibenclamide/placebo administration and CGRP infusion measured by centimeter (cm)

Secondary

Measure	Time frame	Description
Headache	Time of headache measurements is from before (-20 min) and after (12 hours) glibenclamide/placebo administration.	Headache intensity will be recorded by numerical rating scale (NRS) from 0 to 10 (0, no headache; 1, a feeling of pressure; 10, worst imaginable headache).

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026