Hypersensitivity to PACAP-38 in Post-Traumatic Headache

What Was Tested

This registered not phased trial tested PACAP.

It had two arms (groups): PACAP-38 (experimental) and Placebo (isotonic saline) (placebo comparator).

A time- and volume-controlled infusion pump is used to administer PACAP-38 by intravenous infusion over 20 minutes.

A time- and volume-controlled infusion pump is used to administer placebo (isotonic saline) by intravenous infusion over 20 minutes.

The registry classes the interventions as drug.

Who Took Part

The registry lists 21 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 18 to 65 years of age upon entry into screening. Provision of informed consent prior to initiation of any study-specific activities/procedures.

The full record lists 4 inclusion and 15 exclusion criteria; among the exclusions: \> 1 mild traumatic injury to the head; history of moderate or severe injury to the head; history of whiplash injury.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got PACAP and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both PACAP and the comparison in turn, acting as their own control.

Neither the 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 2022-06-16 with completion listed for 2023-12-31.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of PACAP in 21 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the PACAP compound page, all human trials.