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PACAP-38 Infusion in Patients With Cluster Headache
Plain-language guide to NCT03814226: not phased randomized trial of PACAP, 45 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03814226
- Phase
- not phased
- Status
- status unknown
- Start
- 2018-01-01
- Completion (planned or actual)
- 2020-01-01
- Participants
- 45 (estimated)
- Design
- randomized, single-blind, basic_science
- Conditions studied
- Cluster Headache
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test PACAP.
Each patients will on two separate study days in a randomized way receive an infusion of PACAP-38 and VIP over 20 minutes followed by an observation period of 70 minutes.
It had two arms (groups): PACAP-38 infusion (experimental) and VIP infusion (active comparator).
The registry classes the interventions as other.
Who Took Part
Enrollment: 45 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 18-65 years. Weight 50-100 kg.
The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: current or recent use (30 days) of injected or oral corticosteroids; pregnant or lactating women; A history or clinical signs of hypertension (BP \> 150mmHg systolic / 100mmHg diastolic).
How the Study Was Run
The set-up was randomized, crossover and single-blind.
The participants were allocated by chance, so the PACAP group and the comparison group should start out alike.
Each person switched between PACAP and the comparison at some point, usually with a gap in between.
In this single-blind PACAP study one party knew the assignments and the other did not.
Those kept unaware of assignments: investigator.
It started in 2018-01-01 with completion listed for 2020-01-01.
It ran at 1 site in Denmark.
Its stated primary purpose is basic science.
What Was Measured
Researchers chose this as the main measure: Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE (time frame: 90 minutes). Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE after infusion (time frame: 90 minutes). Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE at baseline (time frame: 90 minutes).
It also tracked 2 secondary outcomes, for example Change in mean arterial blood pressure and Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of PACAP in 45 people.
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.
Our Notes on the Compound
PACAP: Pituitary adenylate cyclase-activating polypeptide, a 38-amino-acid neuropeptide studied in migraine provocation research.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.