The Hemodynamic Effects of PACAP38 After Glibenclamide Administration in Healthy Volunteers

Not Applicable

Completed

• Conditions: Pain; Headache; Migraine
• Interventions: Drug: glibenclamide; Drug: PACAP38

• Registration Number: NCT04960657
• Lead Sponsor: Danish Headache Center

Brief Summary

To investigate the hemodynamic effects of PACAP38 after glibenclamide administration.

Detailed 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

Study Timeline

• Study Start: 2020-10-20
• Primary Completion: 2021-03-19
• Study Completion: 2021-03-19
• Study First Submitted: 2021-05-24
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-02
• Last Update Submitted: 2021-07-02
• Study First Posted: 2021-07-14
• Last Update Posted: 2021-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PACAP38 and glibenclamide	glibenclamide	Participants will receive glibenclamide after PACAP38 infusion
PACAP38 and placebo	PACAP38	Participants will receive placebo after PACAP38 infusion
PACAP38 and glibenclamide	PACAP38	Participants will receive glibenclamide after PACAP38 infusion
PACAP38 and placebo	glibenclamide	Participants will receive placebo after PACAP38 infusion

Primary Outcome Measures

Name	Time	Method
Headache	Time of headache measurements is from before (-20 minutes) and up to 12 hours after PACAP38 infusion	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).

Secondary Outcome Measures

Name	Time	Method
Changes in the arterial radialis (RA), superficial temporal artery (STA) and middle cerebral artery (MCA).	Time of measurements is baseline and repeatedly every 20 minutes for 260 minutes.	Repeated measurements covering the diameter of RA, STA and MCA before and after PACAP38 infusion and glibenclamide/placebo administration measured by centimeter (cm)

Trial Locations

Locations (1)

Danish Headache Center; 🇩🇰 Copenhagen, Capital Region, Denmark