The Hemodynamic Effects of PACAP38 After Glibenclamide Administration in Healthy Volunteers

What Was Tested

In this not phased trial, researchers set out to test PACAP for migraine.

To investigate the hemodynamic effects of PACAP38 after glibenclamide administration.

It had two arms (groups): PACAP38 and glibenclamide (active comparator) and PACAP38 and placebo (active comparator).

Participants will receive glibenclamide after PACAP38 infusion.

Participants will receive placebo after PACAP38 infusion.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

Enrollment: 22 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy volunteers of both sexes. Women of childbearing age must use adequate contraception.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: A history of serious somatic or psychiatric disease; daily intake of any medication except contraceptives.

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

Because people in this PACAP study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between PACAP and the comparison at some point, usually with a gap in between.

Neither the migraine participants nor the staff measuring them knew who was on PACAP, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2020-10-20 with completion listed for 2021-03-19.

It ran at 1 site in Denmark.

Its stated primary purpose is other.

What Was Measured

It also tracked 1 secondary outcome, for example Changes in the arterial radialis (RA), superficial temporal artery (STA) and middle cerebral artery (MCA).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of PACAP in 22 people with migraine.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the PACAP compound page, Migraine research.