N/A
N=585
Study of the Molecular Genetics of Menstrual Migraine
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT00904150 ↗Enrolled (actual)
585
Serious AEs
—
Results posted
Feb 2014
Primary outcome: Primary: Progesterone Receptor Gene Polymorphism PROGINS in Women With Menstrual Migraine and Women Without Migraine — 208; 112; 64; 39 participants — p=0.513
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The City of London Migraine Clinic
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progesterone Receptor Gene Polymorphism PROGINS in Women With Menstrual Migraine and Women Without Migraine |
208; 112; 64; 39; 8; 2 | 0.513 |
| PRIMARY Estrogen Receptor 1 G594a Polymorphism in Women With Menstrual Migraine and Women Without Migraine |
196; 101; 76; 43; 8; 6 | 0.75 |
| PRIMARY Estrogen Receptor 1 C325G Polymorphism in Women With Menstrual Migraine and Women Without Migraine |
155; 96; 109; 51; 16; 7 | 0.18 |
| PRIMARY Menstrual Cycle Expression of PGR and ESR in Women With Menstrual Migraine and Women Without Migraine |
15.98; 16.73; 16.58; 15.62; 9.62; 9.80 | >0.05 |
| SECONDARY Tumour Necrosis Factor Genotype in Women With Menstrual Migraine and Women Without Migraine |
1; 2; 40; 20; 149; 32 | 0.002743 sig |
| SECONDARY SYNE1 Genotype in Women With Menstrual Migraine and Women Without Migraine |
24; 25; 102; 54; 89; 40 | 0.02462 sig |
| SECONDARY Menstrual Cycle Expression of TNF and SYNE1 in Women With Menstrual Migraine and Women Without Migraine |
17.16; 17.33; 16.24; 16.96; 21.56; 20.68 | >0.05 |
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
Data sourced from ClinicalTrials.gov (NCT00904150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.