Study of the Molecular Genetics of Menstrual Migraine

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00904150
• Other study ID #: COLMC-GEN-2007
• Secondary ID: REC Ref: 07/H070
• Status: Completed
• Phase: N/A
• First received: May 17, 2009
• Last updated: February 18, 2014
• Start date: November 2007
• Est. completion date: August 2013

Study information

• Verified date: February 2014
• Source: The City of London Migraine Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 585
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Locations

Country	Name	City	State
United Kingdom	The City of London Migraine Clinic	London

Sponsors (2)

Lead Sponsor	Collaborator
The City of London Migraine Clinic	Griffith University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progesterone Receptor Gene Polymorphism PROGINS in Women With Menstrual Migraine and Women Without Migraine	PR PROGINS	6 years	No
Primary	Estrogen Receptor 1 G594a Polymorphism in Women With Menstrual Migraine and Women Without Migraine	ESR1 G594A	6 years	No
Primary	Estrogen Receptor 1 C325G Polymorphism in Women With Menstrual Migraine and Women Without Migraine	ESR1 C325G	6 years	No
Primary	Menstrual Cycle Expression of PGR and ESR in Women With Menstrual Migraine and Women Without Migraine	PgR and ESR	6 years	No
Secondary	Tumour Necrosis Factor Genotype in Women With Menstrual Migraine and Women Without Migraine	TNF	6 years	No
Secondary	SYNE1 Genotype in Women With Menstrual Migraine and Women Without Migraine	SYNE1	6 years	No
Secondary	Menstrual Cycle Expression of TNF and SYNE1 in Women With Menstrual Migraine and Women Without Migraine	TNF and SYNE1	6 years	No