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OpenTrials
Completed

NCT Number: NCT04960657

The Hemodynamic Effects of PACAP38 After Glibenclamide Administration in Healthy Volunteers

To investigate the hemodynamic effects of PACAP38 after glibenclamide administration.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Headache Center

Copenhagen, Capital Region, 2600, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

glibenclamide

Drug

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

PACAP38

Drug

PACAP38 infusion

Other names: Pituitary adenylate cyclase activating polypeptide-38

Primary outcomes

  1. Headache

    Time frame: 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 outcomes

  1. Changes in the arterial radialis (RA), superficial temporal artery (STA) and middle cerebral artery (MCA).

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 14, 2021
Registry last updated
Jul 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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