Study of the Molecular Genetics of Menstrual Migraine

Study Overview
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Brief Summary
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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.

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

Conditions
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Migraine

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1 Menstrual migraine<br>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<br>Caucasian women with no personal history of migraine | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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menstruation, migraine, menstrual migraine, genetics