Back to resultsThe Hemodynamic Effects of PACAP38 After Glibenclamide Administration in Healthy Volunteers
Primary Purpose
Migraine, Headache, Pain
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
glibenclamide
PACAP38
Sponsored by
About this trial
This is an interventional other trial for Migraine focused on measuring Glyburide, Physiological Effects of Drugs, Hypoglycemic Agents
Eligibility Criteria
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
Sites / Locations
- Danish Headache Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
PACAP38 and glibenclamide
PACAP38 and placebo
Arm Description
Participants will receive glibenclamide after PACAP38 infusion
Participants will receive placebo after PACAP38 infusion
Outcomes
Primary 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).
Secondary Outcome Measures
Changes in the arterial radialis (RA), superficial temporal artery (STA) and middle cerebral artery (MCA).
Repeated measurements covering the diameter of RA, STA and MCA before and after PACAP38 infusion and glibenclamide/placebo administration measured by centimeter (cm)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04960657
Brief Title
The Hemodynamic Effects of PACAP38 After Glibenclamide Administration in Healthy Volunteers
Official Title
The Hemodynamic Effects of PACAP38 After Glibenclamide Administration in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
March 19, 2021 (Actual)
Study Completion Date
March 19, 2021 (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
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Headache, Pain
Keywords
Glyburide, Physiological Effects of Drugs, Hypoglycemic Agents
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
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PACAP38 and glibenclamide
Arm Type
Active Comparator
Arm Description
Participants will receive glibenclamide after PACAP38 infusion
Arm Title
PACAP38 and placebo
Arm Type
Active Comparator
Arm Description
Participants will receive placebo after PACAP38 infusion
Intervention Type
Drug
Intervention Name(s)
glibenclamide
Intervention Description
Oral administration of glibenclamide/placebo. To investigate the role of PACAP38 on cranial arteries in healthy volunteers after glibenclamide/placebo administration .
Intervention Type
Drug
Intervention Name(s)
PACAP38
Other Intervention Name(s)
Pituitary adenylate cyclase activating polypeptide-38
Intervention Description
PACAP38 infusion
Primary 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 minutes) and up to 12 hours after PACAP38 infusion
Secondary Outcome Measure Information:
Title
Changes in the arterial radialis (RA), superficial temporal artery (STA) and middle cerebral artery (MCA).
Description
Repeated measurements covering the diameter of RA, STA and MCA before and after PACAP38 infusion and glibenclamide/placebo administration measured by centimeter (cm)
Time Frame
Time of measurements is baseline and repeatedly every 20 minutes for 260 minutes.
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 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
Facility Information:
Facility Name
Danish Headache Center
City
Copenhagen
State/Province
Capital Region
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Hemodynamic Effects of PACAP38 After Glibenclamide Administration in Healthy Volunteers
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