The Hemodynamic Effects of CGRP After Glibenclamide Administration in Healthy Volunteers

Not Applicable

Completed

• Conditions: Hemodynamics of Cranial Arteries; Headache; Cerebral Blood Flow
• Interventions: Drug: CGRP infusion; Drug: glibenclamide; Drug: Placebo

• Registration Number: NCT04231617
• Lead Sponsor: Danish Headache Center

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.

Study Timeline

• Study First Submitted: 2020-01-14
• Study First Submitted QC: 2020-01-15
• Study First Posted: 2020-01-18
• Study Start: 2020-01-20
• Primary Completion: 2020-08-01
• Status Verified: 2020-09
• Study Completion: 2020-09-01
• Last Update Submitted: 2020-09-05
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CGRP and placebo	CGRP infusion	Participants will recieve CGRP infusion after glibenclamide/placebo administration
CGRP and glibenclamide	CGRP infusion	Participants will recieve CGRP infusion after glibenclamide/placebo administration
CGRP and placebo	Placebo	Participants will recieve CGRP infusion after glibenclamide/placebo administration
CGRP and glibenclamide	glibenclamide	Participants will recieve CGRP infusion after glibenclamide/placebo administration

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (2)

Mohammad Al-Mahdi Al-Karagholi; 🇩🇰 København S, Danmark, Denmark

Danish headache center; 🇩🇰 Glostrup, Copenhagen, Denmark