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The Effect of Histamine H1 Receptor Antagonist, Clemastin, on PACAP38 Induced Headache in Migraine Patients
Plain-language guide to NCT02364453: not phased randomized trial of PACAP, migraine, 20 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02364453
- Phase
- not phased
- Status
- completed
- Start
- 2015-02
- Completion (planned or actual)
- 2016-04
- Participants
- 20 (actual)
- Design
- randomized, triple-blind, prevention
- Conditions studied
- Migraine Without Aura
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around PACAP for migraine.
The purpose of this study is to determine the effects of antihistamine (Clemastin) on migraines triggered by pituitary adenylate cyclase activating peptide-38 (PACAP38) as well as on biochemical markers for mast cell degranulation in migraine patients.
Also, to investigate the occurrence of migraine in migraine patients after infusion of PACAP38 in lower dosages than previously investigated.
It had two arms (groups): Placebo to PACAP38 (experimental) and one (experimental).
The registry classes the interventions as drug.
Who Took Part
20 actual participants took part.
It was open to people of any sex aged from 20 years up to 50 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: other types of primary headache than migraine; headache on trial day or later than 48 hours before trial day; migraine up to three days before trial day.
How the Study Was Run
The set-up was randomized, crossover and triple-blind.
The migraine 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.
As a double-blind PACAP study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant, investigator and outcomes assessor.
It started in 2015-02 with completion listed for 2016-04.
It ran at 1 site in Denmark.
Its stated primary purpose is prevention.
What Was Measured
Researchers chose this as the main measure: Development of migraine in migraine patients (time frame: Up to 12 months).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of PACAP in 20 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.
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.