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PACAP Induced Migraine Attacks in Patients With High and Low Genetic Load
Plain-language guide to NCT02158221: not phased non-randomized trial of PACAP, migraine, 32 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02158221
- Phase
- not phased
- Status
- completed
- Start
- 2014-06
- Completion (planned or actual)
- 2014-11
- Participants
- 32 (actual)
- Design
- non-randomized, double-blind
- Conditions studied
- Migraine Without Aura
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested PACAP for migraine.
It had two arms (groups): Migraine patients with high genetic load (active comparator) and Migraine patients with low genetic load (active comparator).
The registry classes the interventions as drug.
More on the Plan
Migraine is a very prevalent neurological disorder with a strong genetic factor.
The common forms of migraine have a multifactorial and polygenic pattern of inheritance and genetics research is crucial for a deeper understanding of migraine mechanisms.
The functional consequences of this genetic variant in humans are yet unknown.
PACAP is a neuropeptide which plays a crucial role in the pathophysiology of migraine and is present in migraine relevant structures.
Who Took Part
The registry lists 32 actual participants took part.
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.
The full record lists 1 inclusion and 7 exclusion criteria; among the exclusions: A history of cerebrovascular disease and other CNS- disease; serious somatic and mental disease; hypo- or hypertension.
How the Study Was Run
It was run as a non-randomized, parallel-group and double-blind study.
Groups ran in parallel: each of the migraine participants stayed in one arm throughout.
Blinding on both sides kept the migraine participants and researchers unaware of who received PACAP.
Those kept unaware of assignments: participant and outcomes assessor.
It started in 2014-06 with completion listed for 2014-11.
It ran at 1 site in Denmark.
What Was Measured
Primary outcome: Incidence of migraine attacks induced by PACAP in patients with high and low genetic load (time frame: Change from baseline in headache intensity at 12 hours after the start of infusion of PACAP).
What This Means in Plain Language
Put simply, this is a not phased, non-randomized trial of PACAP in 32 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.