The Hemodynamic Effects of PACAP38 After Glibenclamide Administration in Healthy Volunteers

July 2, 2021 updated by: Lili Kokoti, Danish Headache Center
To investigate the hemodynamic effects of PACAP38 after glibenclamide administration.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2600
        • Danish Headache Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PACAP38 and glibenclamide
Participants will receive glibenclamide after PACAP38 infusion
Drug: glibenclamide
Oral administration of glibenclamide/placebo. To investigate the role of PACAP38 on cranial arteries in healthy volunteers after glibenclamide/placebo administration .
Drug: PACAP38
PACAP38 infusion
Other Names:
  • Pituitary adenylate cyclase activating polypeptide-38
Active Comparator: PACAP38 and placebo
Participants will receive placebo after PACAP38 infusion
Drug: glibenclamide
Oral administration of glibenclamide/placebo. To investigate the role of PACAP38 on cranial arteries in healthy volunteers after glibenclamide/placebo administration .
Drug: PACAP38
PACAP38 infusion
Other Names:
  • Pituitary adenylate cyclase activating polypeptide-38

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time of headache measurements is from before (-20 minutes) and up to 12 hours after PACAP38 infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time of measurements is baseline and repeatedly every 20 minutes for 260 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Headache Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2020

Primary Completion (Actual)

March 19, 2021

Study Completion (Actual)

March 19, 2021

Study Registration Dates

First Submitted

May 24, 2021

First Submitted That Met QC Criteria

July 2, 2021

First Posted (Actual)

July 14, 2021

Study Record Updates

Last Update Posted (Actual)

July 14, 2021

Last Update Submitted That Met QC Criteria

July 2, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H19065735

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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