Clinical trial NCT00904150: Study of the Molecular Genetics of Menstrual Migraine
Official title: A Case-control Study of the Molecular Genetics of Menstrual Migraine (Pure Menstrual and Menstrually-related Migraine)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Keywords: menstruation
migraine
menstrual migraine
genetics
Lead sponsor: The City of London Migraine Clinic
Sponsor class: OTHER
Collaborators: name: Griffith University
First posted: 2009-05-19
Enrollment: 585
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Caucasian women

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.


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

Primary outcomes:
measure: Progesterone Receptor Gene Polymorphism PROGINS in Women With Menstrual Migraine and Women Without Migraine
timeFrame: 6 years
measure: Estrogen Receptor 1 G594a Polymorphism in Women With Menstrual Migraine and Women Without Migraine
timeFrame: 6 years
measure: Estrogen Receptor 1 C325G Polymorphism in Women With Menstrual Migraine and Women Without Migraine
timeFrame: 6 years
measure: Menstrual Cycle Expression of PGR and ESR in Women With Menstrual Migraine and Women Without Migraine
timeFrame: 6 years
Secondary outcomes:
measure: Tumour Necrosis Factor Genotype in Women With Menstrual Migraine and Women Without Migraine
timeFrame: 6 years
measure: SYNE1 Genotype in Women With Menstrual Migraine and Women Without Migraine
timeFrame: 6 years
measure: Menstrual Cycle Expression of TNF and SYNE1 in Women With Menstrual Migraine and Women Without Migraine
timeFrame: 6 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: The City of London Migraine Clinic
Study officials:
affiliation: Centre for Neuroscience and Trauma, Queen Mary, University of London
name: E A MacGregor, FFSRH MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Genomics Research Centre Griffith University
name: Lyn Griffiths, BSc(Hons) PhD
role: PRINCIPAL_INVESTIGATOR
References: