Study of the Molecular Genetics of Menstrual Migraine

This study has been completed.
Sponsor:
Collaborator:
Griffith University
Information provided by (Responsible Party):
Dr E Anne MacGregor, Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT00904150
First received: May 17, 2009
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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
Migraine

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by The City of London Migraine Clinic:

Primary Outcome Measures:
  • Progesterone Receptor Gene Polymorphism PROGINS in Women With Menstrual Migraine and Women Without Migraine [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    PR PROGINS

  • Estrogen Receptor 1 G594a Polymorphism in Women With Menstrual Migraine and Women Without Migraine [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    ESR1 G594A

  • Estrogen Receptor 1 C325G Polymorphism in Women With Menstrual Migraine and Women Without Migraine [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    ESR1 C325G

  • Menstrual Cycle Expression of PGR and ESR in Women With Menstrual Migraine and Women Without Migraine [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    PgR and ESR


Secondary Outcome Measures:
  • Tumour Necrosis Factor Genotype in Women With Menstrual Migraine and Women Without Migraine [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    TNF

  • SYNE1 Genotype in Women With Menstrual Migraine and Women Without Migraine [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    SYNE1

  • Menstrual Cycle Expression of TNF and SYNE1 in Women With Menstrual Migraine and Women Without Migraine [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    TNF and SYNE1


Biospecimen Retention:   Samples With DNA

Saliva Whole Blood


Enrollment: 585
Study Start Date: November 2007
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00904150

Locations
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
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

No publications provided

Responsible Party: Dr E Anne MacGregor, Professor E Anne MacGregor, Queen Mary University of London
ClinicalTrials.gov Identifier: NCT00904150     History of Changes
Other Study ID Numbers: COLMC-GEN-2007, REC Ref: 07/H0703/107, Proposal # 36470, Grant Application 2007/03
Study First Received: May 17, 2009
Results First Received: September 8, 2013
Last Updated: February 18, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by The City of London Migraine Clinic:
menstruation
migraine
menstrual migraine
genetics

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases

ClinicalTrials.gov processed this record on October 22, 2014