The Hemodynamic Effects of PACAP38 After Glibenclamide Administration in Healthy Volunteers

NCT04960657 — Not applicable, Completed, 22 participants, Danish Headache Center

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Registry	NCT04960657
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: quadruple, other
Enrollment	22 (Actual)
Sponsor	Danish Headache Center (Other)
Conditions	Migraine, Headache, Pain
Interventions	glibenclamide, PACAP38 (Drug)
Dates	start 2020-10-20, primary completion 2021-03-19, completion 2021-03-19, first posted 2021-07-14, last updated 2021-07-14
Locations	1 site in Denmark

-Summary

To investigate the hemodynamic effects of PACAP38 after glibenclamide administration.

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+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

+Arms and interventions

Arm	Type	Interventions	Description
PACAP38 and glibenclamide	Active comparator	Drug: glibenclamide; Drug: PACAP38	Participants will receive glibenclamide after PACAP38 infusion
PACAP38 and placebo	Active comparator	Drug: glibenclamide; Drug: PACAP38	Participants will receive placebo after PACAP38 infusion

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), also known as Pituitary adenylate cyclase activating polypeptide-38: PACAP38 infusion

+Outcome measures

Primary outcomes

Headache [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

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.]: Repeated measurements covering the diameter of RA, STA and MCA before and after PACAP38 infusion and glibenclamide/placebo administration measured by centimeter (cm)

+Eligibility

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Danish Headache Center	Copenhagen, Capital Region	Denmark