Study of the Molecular Genetics of Menstrual Migraine

Completed

• Conditions: Migraine

• Registration Number: NCT00904150
• Lead Sponsor: The City of London Migraine Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2009-05-17
• Study First Submitted QC: 2009-05-18
• Study First Posted: 2009-05-19
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Results First Submitted: 2013-09-08
• Status Verified: 2014-02
• Results First Submitted QC: 2014-02-18
• Last Update Submitted: 2014-02-18
• Results First Posted: 2014-02-24
• Last Update Posted: 2014-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 585

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Menstrual Cycle Expression of TNF and SYNE1 in Women With Menstrual Migraine and Women Without Migraine	6 years	TNF and SYNE1
SYNE1 Genotype in Women With Menstrual Migraine and Women Without Migraine	6 years	SYNE1
Tumour Necrosis Factor Genotype in Women With Menstrual Migraine and Women Without Migraine	6 years	TNF

Trial Locations

Locations (1)

The City of London Migraine Clinic; 🇬🇧 London, United Kingdom