Study of the Molecular Genetics of Menstrual Migraine

A Case-control Study of the Molecular Genetics of Menstrual Migraine (Pure Menstrual and Menstrually-related Migraine)

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.

Study Overview

• Status: Completed
• Conditions: Migraine

• Study Type: Observational
• Enrollment (Actual): 585

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, EC1M 6DX
    • The City of London Migraine Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Caucasian women

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progesterone Receptor Gene Polymorphism PROGINS in Women With Menstrual Migraine and Women Without Migraine	PR PROGINS	6 years
Estrogen Receptor 1 G594a Polymorphism in Women With Menstrual Migraine and Women Without Migraine	ESR1 G594A	6 years
Estrogen Receptor 1 C325G Polymorphism in Women With Menstrual Migraine and Women Without Migraine	ESR1 C325G	6 years
Menstrual Cycle Expression of PGR and ESR in Women With Menstrual Migraine and Women Without Migraine	PgR and ESR	6 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumour Necrosis Factor Genotype in Women With Menstrual Migraine and Women Without Migraine	TNF	6 years
SYNE1 Genotype in Women With Menstrual Migraine and Women Without Migraine	SYNE1	6 years
Menstrual Cycle Expression of TNF and SYNE1 in Women With Menstrual Migraine and Women Without Migraine	TNF and SYNE1	6 years

Collaborators and Investigators

• Sponsor: The City of London Migraine Clinic
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): August 1, 2013

Study Registration Dates

• First Submitted: May 17, 2009
• First Submitted That Met QC Criteria: May 18, 2009
• First Posted (ESTIMATE): May 19, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): February 24, 2014
• Last Update Submitted That Met QC Criteria: February 18, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: genetics; migraine; menstrual migraine; menstruation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: COLMC-GEN-2007; REC Ref: 07/H0703/107; Proposal # 36470; Grant Application 2007/03