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

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ClinicalTrials.gov Identifier: NCT02158221
Recruitment Status : Completed
First Posted : June 6, 2014
Last Update Posted : February 10, 2015
Sponsor:
Information provided by (Responsible Party):
Song Guo, Danish Headache Center

Study Description
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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
Migraine Without Aura Drug: PACAP Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : June 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

Arms and Interventions
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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 Name: 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 Name: Pituitary adenylate cyclase-activating polypeptide


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02158221


Locations
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Denmark
Danish Headache Center & Department of Neurology
Copenhagen, Glostrup, Denmark, 2600
Sponsors and Collaborators
Danish Headache Center
More Information
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Responsible Party: Song Guo, MD, Danish Headache Center
ClinicalTrials.gov Identifier: NCT02158221    
Other Study ID Numbers: H-2-2013-043
First Posted: June 6, 2014    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Migraine Disorders
Migraine without Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Pituitary Adenylate Cyclase-Activating Polypeptide
Growth Substances
Physiological Effects of Drugs
Vasodilator Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action