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Completed

NCT Number: NCT02158221

PACAP Induced Migraine Attacks in Patients With High and Low Genetic Load

The investigators hypothesized that migraine without patients with many genetic loci associated with migraine (high genetic load) would be more sensitive and get provoked more migraine attacks by PACAP compared to patients with few genetic loci associated with migraine (low genetic load).

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Key information

Conditions

Migraine Without Aura Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Headache Center & Department of Neurology

Copenhagen, Glostrup, 2600, Denmark

About this study

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. Recently, 12 genetic loci have been identified to be associated with migraine with (MA) and without aura (MA) in four large genome-wide association studies (GWAS). 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. PACAP can induce migraine attacks in MO patients via an adenosine monophosphate (cAMP) dependent pathway. Also, a recent study has showed that intracellular accumulation of cAMP is crucial for the induction of migraine attacks.

The phenotype of the migraine inducing effects of PACAP might therefore be linked to some of the 12 genetic susceptibility loci that have been identified.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Migraine without aura patients genotyped for the 12 newly idetified gene variants associated with migraine.

Exclusion criteria

  • Other primary headache
  • A history of cerebrovascular disease and other CNS- disease
  • A history suggesting ischaemic heart disease
  • Serious somatic and mental disease
  • Hypo- or hypertension
  • Abuse of alcohol or medicine (opioid analgesics).
  • Pregnant or breastfeeding women.

Treatment and study plan

PACAP

Drug

Pituitary adenylate cyclase-activating polypeptide (PACAP)

Other names: Pituitary adenylate cyclase-activating polypeptide

Primary outcomes

  1. 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

    The difference in incidence of migraine-like attacks after PACAP between patients with and without high genetic load and patients with low genetic load using verbal rating scale (VRS).

Secondary outcomes

  1. Incidence of headache 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

    The difference in area under the curve (AUC) for headache intensity scores (0-12 hours) after infusion of PACAP

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 6, 2014
Registry last updated
Feb 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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