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Completed

NCT Number: NCT00904150

Study of the Molecular Genetics of Menstrual Migraine

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

The City of London Migraine Clinic

London, EC1M 6DX, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Progesterone Receptor Gene Polymorphism PROGINS in Women With Menstrual Migraine and Women Without Migraine

    Time frame: 6 years

    PR PROGINS

  2. Estrogen Receptor 1 G594a Polymorphism in Women With Menstrual Migraine and Women Without Migraine

    Time frame: 6 years

    ESR1 G594A

  3. Estrogen Receptor 1 C325G Polymorphism in Women With Menstrual Migraine and Women Without Migraine

    Time frame: 6 years

    ESR1 C325G

  4. Menstrual Cycle Expression of PGR and ESR in Women With Menstrual Migraine and Women Without Migraine

    Time frame: 6 years

    PgR and ESR

Secondary outcomes

  1. Tumour Necrosis Factor Genotype in Women With Menstrual Migraine and Women Without Migraine

    Time frame: 6 years

    TNF

  2. SYNE1 Genotype in Women With Menstrual Migraine and Women Without Migraine

    Time frame: 6 years

    SYNE1

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

    Time frame: 6 years

    TNF and SYNE1

Sponsors and collaborators

Lead sponsor

The City of London Migraine Clinic

Other

Collaborators

  • Griffith University

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
May 19, 2009
Registry last updated
Feb 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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