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

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ClinicalTrials.gov Identifier: NCT01924052
Recruitment Status : Completed
First Posted : August 16, 2013
Last Update Posted : August 16, 2013
Sponsor:
Information provided by (Responsible Party):
Song Guo, Danish Headache Center

Tracking Information
First Submitted Date  ICMJE August 10, 2013
First Posted Date  ICMJE August 16, 2013
Last Update Posted Date August 16, 2013
Study Start Date  ICMJE June 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2013)
CGRP induced migraine attacks 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 CGRP ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2013)
CGRP induced migraine attacks 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 CGRP ]
The difference in area under the curve (AUC) for headache intensity scores (0-12 hours)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CGRP Induced Migraine Attacks in Patients With High and Low Genetic Load
Official Title  ICMJE CGRP Induced Migraine Attacks in Patients With High and Low Genetic Load
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Condition  ICMJE Migraine Without Aura
Intervention  ICMJE Drug: CGRP
Calcitonin-gene-related-peptide (CGRP)
Other Name: calcitonin-gene-related peptide
Study Arms  ICMJE
  • Active Comparator: Migraine patients with high genetic load
    CGRP intravenous infusion 1.5 microgram/min for 20 min
    Intervention: Drug: CGRP
  • Active Comparator: Migraine patients with low genetic load
    CGRP intravenous infusion 1.5 microgram/min for 20 min
    Intervention: Drug: CGRP
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 14, 2013)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01924052
Other Study ID Numbers  ICMJE H-2-2011-141
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Song Guo, Danish Headache Center
Study Sponsor  ICMJE Danish Headache Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Song Guo, MD Danish Headache Center & Department of Neurology
PRS Account Danish Headache Center
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP