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

Primary Purpose

Migraine Without Aura

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CGRP
Sponsored by
Danish Headache Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Migraine Without Aura

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Migraine patients with high genetic load

    Migraine patients with low genetic load

    Arm Description

    CGRP intravenous infusion 1.5 microgram/min for 20 min

    CGRP intravenous infusion 1.5 microgram/min for 20 min

    Outcomes

    Primary Outcome Measures

    CGRP induced migraine attacks in patients with high and low genetic load
    The difference in incidence of migraine-like attacks between patients with high genetic load and patients with low genetic load using verbal rating scale (VRS).

    Secondary Outcome Measures

    CGRP induced migraine attacks in patients with high and low genetic load
    The difference in area under the curve (AUC) for headache intensity scores (0-12 hours)

    Full Information

    First Posted
    August 10, 2013
    Last Updated
    July 31, 2022
    Sponsor
    Danish Headache Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01924052
    Brief Title
    CGRP Induced Migraine Attacks in Patients With High and Low Genetic Load
    Official Title
    CGRP Induced Migraine Attacks in Patients With High and Low Genetic Load
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    August 2013 (Actual)
    Study Completion Date
    August 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Danish Headache Center

    4. Oversight

    Data Monitoring Committee
    No

    5. 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 calcitonin gene-related peptide (CGRP) compared to patients with few genetic loci associated with migraine (low genetic load).
    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 these genetic loci in humans are yet unknown. Calcitonin gene-related peptide (CGRP) is a neuropeptide which plays a crucial role in the pathophysiology of migraine and is present in migraine relevant structures. CGRP can induce migraine attacks in MO patients via an adenosine monophosphate (cAMP) dependent pathway and CGRP antagonism is efficient in the treatment of migraine attacks. Also, a recent study has showed that intracellular accumulation of cAMP is crucial for the induction of migraine attacks. However, CGRP does not cause migraine attacks in familial hemiplegic migraine (FHM), an autosomal dominant subtype of MA. The phenotype of the migraine inducing effects of CGRP might therefore be linked to some of the 12 genetic susceptibility loci that have been identified. One of the genetic loci (rs13208321) is located in a gene (FHL5) that is associated with the regulation of cAMP-responsive elements.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Migraine Without Aura

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Migraine patients with high genetic load
    Arm Type
    Active Comparator
    Arm Description
    CGRP intravenous infusion 1.5 microgram/min for 20 min
    Arm Title
    Migraine patients with low genetic load
    Arm Type
    Active Comparator
    Arm Description
    CGRP intravenous infusion 1.5 microgram/min for 20 min
    Intervention Type
    Drug
    Intervention Name(s)
    CGRP
    Other Intervention Name(s)
    calcitonin-gene-related peptide
    Intervention Description
    Calcitonin-gene-related-peptide (CGRP)
    Primary Outcome Measure Information:
    Title
    CGRP induced migraine attacks in patients with high and low genetic load
    Description
    The difference in incidence of migraine-like attacks between patients with 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 CGRP
    Secondary Outcome Measure Information:
    Title
    CGRP induced migraine attacks in patients with high and low genetic load
    Description
    The difference in area under the curve (AUC) for headache intensity scores (0-12 hours)
    Time Frame
    Change from baseline in headache intensity at 12 hours after the start of infusion of CGRP

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Song Guo, MD
    Organizational Affiliation
    Danish Headache Center & Department of Neurology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

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