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

February 9, 2015 updated by: Song Guo, Danish Headache Center
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Glostrup
      • Copenhagen, Glostrup, Denmark, 2600
        • Danish Headache Center & Department of Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Change from baseline in headache intensity at 12 hours after the start of infusion of PACAP

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline in headache intensity at 12 hours after the start of infusion of PACAP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Headache Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

June 5, 2014

First Submitted That Met QC Criteria

June 5, 2014

First Posted (Estimate)

June 6, 2014

Study Record Updates

Last Update Posted (Estimate)

February 10, 2015

Last Update Submitted That Met QC Criteria

February 9, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2-2013-043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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