Study of the Molecular Genetics of Menstrual Migraine
This study is ongoing, but not recruiting participants.
Sponsor:
The City of London Migraine Clinic
Collaborator:
Griffith University
Information provided by (Responsible Party):
The City of London Migraine Clinic
ClinicalTrials.gov Identifier:
NCT00904150
First received: May 17, 2009
Last updated: December 13, 2012
Last verified: December 2012
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Purpose
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.
| Condition |
|---|
|
Migraine |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | A Case-control Study of the Molecular Genetics of Menstrual Migraine (Pure Menstrual and Menstrually-related Migraine) |
Resource links provided by NLM:
Further study details as provided by The City of London Migraine Clinic:
Primary Outcome Measures:
- analyse DNA to determine if genes whose function already implicates them in migraine are more common in cases with menstrual migraine than in controls [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- analyse RNA to examine if hormonal changes during menstruation affect the expression of the implicated genes [ Time Frame: 6 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- analyse DNA to identify new genes that may be involved in menstrual migraine development [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- analyse RNA to examine if hormonal changes during menstruation affect the expression of these genes [ Time Frame: 6 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Saliva Whole Blood
| Estimated Enrollment: | 600 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | November 2018 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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 or first-degree family history of migraine
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Caucasian women
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00904150
Locations
| United Kingdom | |
| The City of London Migraine Clinic | |
| London, United Kingdom, EC1M 6DX | |
Sponsors and Collaborators
The City of London Migraine Clinic
Griffith University
Investigators
| Principal Investigator: | E A MacGregor, MFSRH MD | The City of London Migraine Clinic |
| Principal Investigator: | Lyn Griffiths, BSc(Hons) PhD | Genomics Research Centre Griffith University |
More Information
No publications provided
| Responsible Party: | The City of London Migraine Clinic |
| ClinicalTrials.gov Identifier: | NCT00904150 History of Changes |
| Other Study ID Numbers: | COLMC-GEN-2007, REC Ref: 07/H0703/107, Proposal # 36470, Grant Application 2007/03 |
| Study First Received: | May 17, 2009 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by The City of London Migraine Clinic:
|
menstruation migraine menstrual migraine genetics |
Additional relevant MeSH terms:
|
Migraine Disorders Premenstrual Syndrome Headache Disorders, Primary Headache Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Menstruation Disturbances Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013