Trials Sponsors Conditions Drugs Pricing

Conditions

Migraine Headache Pain

Keywords

GlyburidePhysiological Effects of DrugsHypoglycemic Agents

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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.

Study Arms (2)

PACAP38 and glibenclamide

ACTIVE COMPARATOR

Participants will receive glibenclamide after PACAP38 infusion

Drug: glibenclamideDrug: PACAP38

PACAP38 and placebo

ACTIVE COMPARATOR

Participants will receive placebo after PACAP38 infusion

Drug: glibenclamideDrug: PACAP38

Interventions

glibenclamideDrug

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

PACAP38 and glibenclamidePACAP38 and placebo

PACAP38Drug

PACAP38 infusion

Also known as: Pituitary adenylate cyclase activating polypeptide-38

Eligibility Criteria

Age18 Years - 60 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy volunteers of both sexes.
years.

Sponsors & Collaborators

Danish Headache Center
Otherlead

Study Sites (1)

Danish Headache Center

Copenhagen, Capital Region, 2600, Denmark

MeSH Terms

Conditions

Migraine DisordersHeadachePain

Interventions

GlyburidePituitary Adenylate Cyclase-Activating Polypeptide

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Enrollment

22 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: OTHER
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: MD, PhD student, Principal investigator

Study Record Dates

First Submitted

May 24, 2021

First Posted

July 14, 2021

Study Start

October 20, 2020

The Hemodynamic Effects of PACAP38 After Glibenclamide Administration in Healthy Volunteers

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

PACAP38 and glibenclamide

PACAP38 and placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

PACAP38 and glibenclamide

PACAP38 and placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations