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NCT04960657 Clinical Trial

The Hemodynamic Effects of PACAP38 After Glibenclamide Administration in Healthy Volunteers

Pain Clinical Trial

Official title:
The Hemodynamic Effects of PACAP38 After Glibenclamide Administration in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04960657
Other study ID # H19065735
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 20, 2020
Est. completion date March 19, 2021

Study information
Verified date July 2021
Source Danish Headache Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To investigate the hemodynamic effects of PACAP38 after glibenclamide administration.

Description:

22 healthy participants will randomly be allocated to receive PACAP38 infusion followed by glibenclamide or placebo on two different days. The aim of the study is to investigate the vascular effect of PACAP38 after glibenclamide administration. Repeated measurements covering the arteria radialis (RA), superficial temporal artery (STA) and middle cerebral artery (MCA) before and after PACAP38 infusion and glibenclamide/placebo administration

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date March 19, 2021
Est. primary completion date March 19, 2021
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 age must use adequate contraception Exclusion Criteria: - A history of serious somatic or psychiatric disease - Migraine or any other type of headache (except episodic tension-type headache less than 5 days per month) - Daily intake of any medication except contraceptives

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• glibenclamide
Oral administration of glibenclamide/placebo. To investigate the role of PACAP38 on cranial arteries in healthy volunteers after glibenclamide/placebo administration .
• PACAP38
PACAP38 infusion

Locations
Country Name City State
Denmark Danish Headache Center Copenhagen Capital Region

Sponsors (1)
Lead Sponsor Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 minutes) and up to 12 hours after PACAP38 infusion
Secondary Changes in the arterial radialis (RA), superficial temporal artery (STA) and middle cerebral artery (MCA). Repeated measurements covering the diameter of RA, STA and MCA before and after PACAP38 infusion and glibenclamide/placebo administration measured by centimeter (cm) Time of measurements is baseline and repeatedly every 20 minutes for 260 minutes.
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