The Hemodynamic Effects of CGRP After Glibenclamide Administration in Healthy Volunteers

Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04231617
• Other study ID #: H-19065735
• Status: Completed
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: September 1, 2020

Study information

• Verified date: September 2020
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the hemodynamic effects of CGRP after glibenclamide administration.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Blood Flow
• Headache
• Hemodynamics of Cranial Arteries

Intervention

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

Locations

Country	Name	City	State
Denmark	Danish headache center	Glostrup	Copenhagen
Denmark	Mohammad Al-Mahdi Al-Karagholi	København S	Danmark

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the arterial radialis (RA), superficiel temporal artery (STA) and middle cerebral artery (MCA)	Repeated measurements covering the diameter of RA , STA and MCA before and after glibenclamide/placebo administration and CGRP infusion measured by centimeter (cm)	Time of measurements is baseline and repeatedly every 20 min for 240 min.
Secondary	Headache	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).	Time of headache measurements is from before (-20 min) and after (12 hours) glibenclamide/placebo administration.