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Completed

NCT Number: NCT04231617

The Hemodynamic Effects of CGRP After Glibenclamide Administration in Healthy Volunteers

To investigate the hemodynamic effects of CGRP after glibenclamide administration.

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Key information

Conditions

Hemodynamics of Cranial Arteries Cerebral Blood Flow Headache Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish headache center, Glostrup Municipality, Copenhagen, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

glibenclamide

Drug

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

CGRP infusion

Drug

CGRP infusion

Placebo

Drug

placebo

Primary outcomes

  1. Changes in the arterial radialis (RA), superficiel temporal artery (STA) and middle cerebral artery (MCA)

    Time frame: 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 outcomes

  1. Headache

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 18, 2020
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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