Study of the Molecular Genetics of Menstrual Migraine

NCT ID: NCT00904150

Last Updated: 2014-02-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 585 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2013-08-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

No interventions assigned to this group

2 No migraine

Caucasian women with no personal history of migraine

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Griffith University

OTHER

Sponsor Role: collaborator

The City of London Migraine Clinic

OTHER

Sponsor Role: lead

Responsible Party

Dr E Anne MacGregor

Professor E Anne MacGregor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

E A MacGregor, FFSRH MD

Role: PRINCIPAL_INVESTIGATOR

Centre for Neuroscience and Trauma, Queen Mary, University of London

Lyn Griffiths, BSc(Hons) PhD

Role: PRINCIPAL_INVESTIGATOR

Genomics Research Centre Griffith University

Locations

The City of London Migraine Clinic

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

REC Ref: 07/H0703/107

Identifier Type: -

Identifier Source: secondary_id

Proposal # 36470

Identifier Type: -

Identifier Source: secondary_id

Grant Application 2007/03

Identifier Type: -

Identifier Source: secondary_id

COLMC-GEN-2007

Identifier Type: -

Identifier Source: org_study_id