The Hemodynamic Effects of PACAP38 After Glibenclamide Administration in Healthy Volunteers

Danish Headache Center

Status: Completed

Conditions: Migraine; Pain; Headache

Treatments: Drug: PACAP38; Drug: glibenclamide

Study type: Interventional

Funder types: Other

Identifiers

NCT04960657

H19065735

Details and patient eligibility

About

To investigate the hemodynamic effects of PACAP38 after glibenclamide administration.

Full 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

Enrollment: 22 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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22 participants in 2 patient groups

PACAP38 and glibenclamide

Active Comparator group

Description:

Participants will receive glibenclamide after PACAP38 infusion

Treatment:

Drug: glibenclamide

Drug: PACAP38

PACAP38 and placebo

Active Comparator group

Description:

Participants will receive placebo after PACAP38 infusion

Treatment:

Drug: glibenclamide

Drug: PACAP38