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

NCT ID: NCT02158221

Last Updated: 2015-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2014-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Migraine Without Aura

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Migraine patients with high genetic load

PACAP intravenous infusion 1.5 microgram/min for 20 min

Group Type ACTIVE_COMPARATOR

PACAP

Intervention Type DRUG

Pituitary adenylate cyclase-activating polypeptide (PACAP)

Migraine patients with low genetic load

PACAP intravenous infusion 1.5 microgram/min for 20 min

Group Type ACTIVE_COMPARATOR

PACAP

Intervention Type DRUG

Pituitary adenylate cyclase-activating polypeptide (PACAP)

Interventions

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PACAP

Pituitary adenylate cyclase-activating polypeptide (PACAP)

Intervention Type DRUG

Other Intervention Names

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Pituitary adenylate cyclase-activating polypeptide

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Headache Center

OTHER

Sponsor Role lead

Responsible Party

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Song Guo

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Danish Headache Center & Department of Neurology

Copenhagen, Glostrup, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-2-2013-043

Identifier Type: -

Identifier Source: org_study_id

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