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

Sponsor
Danish Headache Center (Other)
Overall Status
Completed
CT.gov ID
NCT02158221
Collaborator
(none)
32
Enrollment
1
Location
2
Arms
6
Duration (Months)
5.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

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 Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Official Title:
PACAP Induced Migraine Attacks in Patients With High and Low Genetic Load
Study Start Date :
Jun 1, 2014
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Migraine patients with high genetic load

PACAP intravenous infusion 1.5 microgram/min for 20 min

Drug: PACAP
Pituitary adenylate cyclase-activating polypeptide (PACAP)
Other Names:
  • Pituitary adenylate cyclase-activating polypeptide

    		•
    Active Comparator: Migraine patients with low genetic load

    PACAP intravenous infusion 1.5 microgram/min for 20 min

    Drug: PACAP
    Pituitary adenylate cyclase-activating polypeptide (PACAP)
    Other Names:
  • Pituitary adenylate cyclase-activating polypeptide

    		•

    Outcome Measures

    Primary Outcome Measures

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

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Danish Headache Center & Department of Neurology Copenhagen Glostrup Denmark 2600

    Sponsors and Collaborators

    • Danish Headache Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Song Guo, MD, Danish Headache Center
    ClinicalTrials.gov Identifier:
    NCT02158221
    Other Study ID Numbers:
    • H-2-2013-043
    First Posted:
    Jun 6, 2014
    Last Update Posted:
    Feb 10, 2015
    Last Verified:
    Feb 1, 2015
    Additional relevant MeSH terms:
    Migraine Disorders
    Migraine without Aura
    Pituitary Adenylate Cyclase-Activating Polypeptide

    Study Results

    No Results Posted as of Feb 10, 2015