Study of the Molecular Genetics of Menstrual Migraine

NCT00904150 | Completed Results

• 4 other identifiers: COLMC-GEN-2007REC Ref: 07/H0703/107Proposal # 36470Grant Application 2007/03
• Study Type: observational
• Target: 585
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

menstruation; migraine; menstrual migraine; genetics

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Tumour Necrosis Factor Genotype in Women With Menstrual Migraine and Women Without Migraine

  6 years

• SYNE1 Genotype in Women With Menstrual Migraine and Women Without Migraine

  6 years

• Menstrual Cycle Expression of TNF and SYNE1 in Women With Menstrual Migraine and Women Without Migraine

  6 years

Study Arms (2)

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 Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Caucasian women

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The City of London Migraine Clinic: lead
• Griffith University: collaborator

Study Sites (1)

The City of London Migraine Clinic

London, EC1M 6DX, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva Whole Blood

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Professor Anne MacGregor
• Organization: Centre for Neuroscience and Trauma, Queen Mary, University of London

e.macgregor@qmul.ac.uk

+44 7774 868628

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor E Anne MacGregor

Study Record Dates

• First Submitted: May 17, 2009
• First Posted: May 19, 2009
• Study Start: November 1, 2007
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: February 24, 2014
• Results First Posted: February 24, 2014

Record last verified: 2014-02

Locations

GB (1)