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Study of the Molecular Genetics of Menstrual Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00904150
Recruitment Status : Completed
First Posted : May 19, 2009
Results First Posted : February 24, 2014
Last Update Posted : February 24, 2014
Sponsor:
Collaborator:
Griffith University
Information provided by (Responsible Party):
Dr E Anne MacGregor, Queen Mary University of London

Study Description
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Brief Summary:

The investigators hypothesize that genes that play a role in menstrual migraine can be identified using a well characterised migraine population and a comprehensive genome-wide association scan approach.

The aim of the study is to identify genes, genetic regions, and the effect of hormones on expression profiles in women with menstrual migraine compared to a control population with no personal or first-degree family history of migraine.

In this case control study, saliva samples will be taken from 300 cases and 300 controls for DNA analysis. Blood samples from 30 cases and 30 controls will be taken during the follicular phase as well as the luteal phase of the menstrual cycle for ribonucleic acid (RNA) analysis.


Condition or disease
Migraine

Study Design
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Study Type : Observational
Actual Enrollment : 585 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: A Case-control Study of the Molecular Genetics of Menstrual Migraine (Pure Menstrual and Menstrually-related Migraine)
Study Start Date : November 2007
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine

Groups and Cohorts
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Group/Cohort
1 Menstrual migraine
Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
2 No migraine
Caucasian women with no personal history of migraine


Outcome Measures
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Primary Outcome Measures :
  1. Progesterone Receptor Gene Polymorphism PROGINS in Women With Menstrual Migraine and Women Without Migraine [ Time Frame: 6 years ]
    PR PROGINS

  2. Estrogen Receptor 1 G594a Polymorphism in Women With Menstrual Migraine and Women Without Migraine [ Time Frame: 6 years ]
    ESR1 G594A

  3. Estrogen Receptor 1 C325G Polymorphism in Women With Menstrual Migraine and Women Without Migraine [ Time Frame: 6 years ]
    ESR1 C325G

  4. Menstrual Cycle Expression of PGR and ESR in Women With Menstrual Migraine and Women Without Migraine [ Time Frame: 6 years ]
    PgR and ESR


Secondary Outcome Measures :
  1. Tumour Necrosis Factor Genotype in Women With Menstrual Migraine and Women Without Migraine [ Time Frame: 6 years ]
    TNF

  2. SYNE1 Genotype in Women With Menstrual Migraine and Women Without Migraine [ Time Frame: 6 years ]
    SYNE1

  3. Menstrual Cycle Expression of TNF and SYNE1 in Women With Menstrual Migraine and Women Without Migraine [ Time Frame: 6 years ]
    TNF and SYNE1


Biospecimen Retention:   Samples With DNA
Saliva Whole Blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Caucasian women
Criteria

Inclusion Criteria:

All cases and controls must:

  • Be over 18 years
  • Caucasian
  • Provide written, informed consent
  • Clearly understand and be able to comply with all the trial procedures, as required
  • Not have taken part in trials of any investigational products within the previous 4 weeks

DNA Study:

  • Cases must have at least a 12-month current or past history of menstrual migraine

RNA Study:

  • Cases must have at least a 12-month current history of menstrual migraine
  • Cases must have kept at least three months of headache diary data in advance of visit in order to confirm diagnosis
  • Controls must still be having menstrual periods

Exclusion Criteria:

DNA Study:

  • Cases and controls must not have smoked, chewed gum or consumed any food or drink in the 30 minutes prior to sample collection

RNA Study:

  • Cases and controls will not be eligible for participation if they have:

    • Polycystic ovarian syndrome;
    • Taken any hormones or drugs in the previous three months that may affect normal hormone activity (e.g., hormonal contraceptives, hormone replacement therapy, dietary supplements such as isoflavones);
    • Donated or lost a significant amount of blood (> 550 mL) within the previous 12 weeks
    • Additionally, controls must not have a personal or family history in any first-degree relative of current or past migraine
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): NCT00904150


Locations
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United Kingdom
The City of London Migraine Clinic
London, United Kingdom, EC1M 6DX
Sponsors and Collaborators
The City of London Migraine Clinic
Griffith University
Investigators
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Principal Investigator: E A MacGregor, FFSRH MD Centre for Neuroscience and Trauma, Queen Mary, University of London
Principal Investigator: Lyn Griffiths, BSc(Hons) PhD Genomics Research Centre Griffith University
More Information
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Responsible Party: Dr E Anne MacGregor, Professor E Anne MacGregor, Queen Mary University of London
ClinicalTrials.gov Identifier: NCT00904150    
Other Study ID Numbers: COLMC-GEN-2007
REC Ref: 07/H0703/107
Proposal # 36470
Grant Application 2007/03
First Posted: May 19, 2009    Key Record Dates
Results First Posted: February 24, 2014
Last Update Posted: February 24, 2014
Last Verified: February 2014
Keywords provided by Dr E Anne MacGregor, Queen Mary University of London:
menstruation
migraine
menstrual migraine
genetics
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases