search
Back to results

The Hemodynamic Effects of CGRP After Glibenclamide Administration in Healthy Volunteers

Primary Purpose

Hemodynamics of Cranial Arteries, Headache, Cerebral Blood Flow

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
glibenclamide
CGRP infusion
Placebo
Sponsored by
Danish Headache Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hemodynamics of Cranial Arteries

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteers of both sexes.
  • 18-60 years.
  • 50-100 kg.
  • Women of childbearing potential must use adequate contraception

Exclusion Criteria:

  • A history of serious somatic disease
  • Migraine or any other type of headache (except episodic tension-type headache less than once a month)
  • Daily intake of any medication except contraceptives

Sites / Locations

  • Danish headache center
  • Mohammad Al-Mahdi Al-Karagholi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

CGRP and glibenclamide

CGRP and placebo

Arm Description

Participants will recieve CGRP infusion after glibenclamide/placebo administration

Participants will recieve CGRP infusion after glibenclamide/placebo administration

Outcomes

Primary Outcome Measures

Changes in the arterial radialis (RA), superficiel temporal artery (STA) and middle cerebral artery (MCA)
Repeated measurements covering the diameter of RA , STA and MCA before and after glibenclamide/placebo administration and CGRP infusion measured by centimeter (cm)

Secondary Outcome Measures

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).

Full Information

First Posted
January 14, 2020
Last Updated
September 5, 2020
Sponsor
Danish Headache Center
search

1. Study Identification

Unique Protocol Identification Number
NCT04231617
Brief Title
The Hemodynamic Effects of CGRP After Glibenclamide Administration in Healthy Volunteers
Official Title
The Hemodynamic Effects of CGRP After Glibenclamide Administration in a Randomized Double-blind Cross-over Placebo-controlled Study With Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To investigate the hemodynamic effects of CGRP after glibenclamide administration.
Detailed Description
20 healthy participants will randomly be allocated to receive CGRP infusion followed by glibenclamide or placebo on two different days. The aim of the study is to investigate the vascular effect of CGRP after glibenclamide administration. Repeated measurements covering the arteria radialis (RA), superficiel temporal artery (STA) and middle cerebral artery (MCA) before and after glibenclamide/placebo administration and CGRP infusion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodynamics of Cranial Arteries, Headache, Cerebral Blood Flow

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, double-blind, cross-over, placebo-controlled design in healthy volunteers.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CGRP and glibenclamide
Arm Type
Active Comparator
Arm Description
Participants will recieve CGRP infusion after glibenclamide/placebo administration
Arm Title
CGRP and placebo
Arm Type
Active Comparator
Arm Description
Participants will recieve CGRP infusion after glibenclamide/placebo administration
Intervention Type
Drug
Intervention Name(s)
glibenclamide
Intervention Description
Oral administration of glibenclamide or placebo. To investigate the role of CGRP on cranial arteries in healthy volunteers after glibenclamide/placebo administration .
Intervention Type
Drug
Intervention Name(s)
CGRP infusion
Intervention Description
CGRP infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Changes in the arterial radialis (RA), superficiel temporal artery (STA) and middle cerebral artery (MCA)
Description
Repeated measurements covering the diameter of RA , STA and MCA before and after glibenclamide/placebo administration and CGRP infusion measured by centimeter (cm)
Time Frame
Time of measurements is baseline and repeatedly every 20 min for 240 min.
Secondary Outcome Measure Information:
Title
Headache
Description
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 Frame
Time of headache measurements is from before (-20 min) and after (12 hours) glibenclamide/placebo administration.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteers of both sexes. 18-60 years. 50-100 kg. Women of childbearing potential must use adequate contraception Exclusion Criteria: A history of serious somatic disease Migraine or any other type of headache (except episodic tension-type headache less than once a month) Daily intake of any medication except contraceptives
Facility Information:
Facility Name
Danish headache center
City
Glostrup
State/Province
Copenhagen
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Mohammad Al-Mahdi Al-Karagholi
City
København S
State/Province
Danmark
ZIP/Postal Code
2300
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

The Hemodynamic Effects of CGRP After Glibenclamide Administration in Healthy Volunteers

We'll reach out to this number within 24 hrs