The Hemodynamic Effects of PACAP38 After Glibenclamide Administration in Healthy Volunteers

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04960657

Enrollment

Registered

2021-07-14

Start date

2020-10-20

Completion date

2021-03-19

Last updated

2021-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Headache, Migraine, Pain

Keywords

Glyburide, Physiological Effects of Drugs, Hypoglycemic Agents

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

Interventions

DRUGglibenclamide

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

DRUGPACAP38

PACAP38 infusion

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Randomized, double-blind, cross-over, placebo-controlled design in healthy volunteers.

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026