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

Danish Headache Center32 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Migraine Without Aura

Interventions

PACAPDRUG

Pituitary adenylate cyclase-activating polypeptide (PACAP)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Danish Headache Center & Department of Neurology

Copenhagen, Glostrup, Denmark

Outcomes

Primary Outcomes

Incidence of migraine attacks induced by PACAP in patients with high and low genetic load.

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).

Time frame: Change from baseline in headache intensity at 12 hours after the start of infusion of PACAP

Secondary Outcomes

Incidence of headache induced by PACAP in patients with high and low genetic load.

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

Time frame: Change from baseline in headache intensity at 12 hours after the start of infusion of PACAP

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.