Study of the Molecular Genetics of Menstrual Migraine

An observational study of Migraine, run by The City of London Migraine Clinic at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Migraine
How many people: 585 participants
Where: 1 siteUnited Kingdom
Study dates: Nov 2007to Aug 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Study population: Caucasian women

Who may be able to join

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

Show all 12Show fewer

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

The City of London Migraine Clinic
London, EC1M 6DX

Other trials in United Kingdom

About this study

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

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.

Conditions: Migraine
Keywords: menstruation, migraine, menstrual migraine, genetics
Medical subject headings: Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00904150
Study group	Role	What they receive
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 history of migraine

What is being measured

The primary outcome is the main question the study is designed to answer.

Progesterone Receptor Gene Polymorphism PROGINS in Women With Menstrual Migraine and Women Without Migraine
PR PROGINS
Measured: 6 years
Estrogen Receptor 1 G594a Polymorphism in Women With Menstrual Migraine and Women Without Migraine
ESR1 G594A
Measured: 6 years
Estrogen Receptor 1 C325G Polymorphism in Women With Menstrual Migraine and Women Without Migraine
ESR1 C325G
Measured: 6 years
Menstrual Cycle Expression of PGR and ESR in Women With Menstrual Migraine and Women Without Migraine
PgR and ESR
Measured: 6 years

Secondary outcomes (3)

Tumour Necrosis Factor Genotype in Women With Menstrual Migraine and Women Without Migraine
TNF
Measured: 6 years
SYNE1 Genotype in Women With Menstrual Migraine and Women Without Migraine
SYNE1
Measured: 6 years
Menstrual Cycle Expression of TNF and SYNE1 in Women With Menstrual Migraine and Women Without Migraine
TNF and SYNE1
Measured: 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2007Aug 2013

First posted19 May 2009 (estimated)
Study startNov 2007
Primary completionAug 2013
Study completionAug 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MigraineStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Cross-sectional
Enrolment: 585 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00904150
Sponsor's protocol ID: COLMC-GEN-2007
Other IDs: REC Ref: 07/H0703/107, Proposal # 36470, Grant Application 2007/03
Status last verified: Feb 2014
First submitted: 17 May 2009
Last updated: 24 Feb 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of the Glymphatic System in Migraine
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App-Based Migraine Treatment: The Health enSuite Study
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A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
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All Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Case-control Study of the Molecular Genetics of Menstrual Migraine (Pure Menstrual and Menstrually-related Migraine)
ClinicalTrials.gov ID: NCT00904150
Acronym / sponsor ID: COLMC-GEN-2007
Conditions: Migraine
Keywords: menstruation, migraine, menstrual migraine, genetics
Study type: Observational
Recruitment status: Completed
Enrolment: 585 participants (actual)
Lead sponsor: The City of London Migraine ClinicUniversity, hospital or other
Collaborators: Griffith University
Study start: Nov 2007
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 19 May 2009 (estimated)
Results: Posted 24 Feb 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case-control
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
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 history of migraine

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Caucasian women

Key inclusion criteria (12 listed)

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

Key exclusion criteria (8 listed)

Cases and controls must not have smoked, chewed gum or consumed any food or drink in the 30 minutes prior to sample collection
Cases and controls will not be eligible for participation if they have:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Progesterone Receptor Gene Polymorphism PROGINS in Women With Menstrual Migraine and Women Without Migraine
Time frame: 6 years
PR PROGINS
Estrogen Receptor 1 G594a Polymorphism in Women With Menstrual Migraine and Women Without Migraine
Time frame: 6 years
ESR1 G594A
Estrogen Receptor 1 C325G Polymorphism in Women With Menstrual Migraine and Women Without Migraine
Time frame: 6 years
ESR1 C325G
Menstrual Cycle Expression of PGR and ESR in Women With Menstrual Migraine and Women Without Migraine
Time frame: 6 years
PgR and ESR

3 secondary outcomes

Tumour Necrosis Factor Genotype in Women With Menstrual Migraine and Women Without Migraine
Time frame: 6 years
SYNE1 Genotype in Women With Menstrual Migraine and Women Without Migraine
Time frame: 6 years
Menstrual Cycle Expression of TNF and SYNE1 in Women With Menstrual Migraine and Women Without Migraine
Time frame: 6 years

Results and safety

Results posted to the registry on 24 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1 Menstrual Migraine	285	282
2 No Migraine	300	155

Primary outcome: Progesterone Receptor Gene Polymorphism PROGINS in Women With Menstrual Migraine and Women Without Migraine

Time frame: 6 years. Number. Unit: participants

Measure	1 Menstrual Migraine n = 280	2 No Migraine n = 153
No PROGINS insert	208	112
Heterozygote	64	39
Homozygote	8	2

1 Menstrual Migraine vs 2 No Migraine: p = 0.513, Chi-squared

Population analysed: Not all samples were suitable for analysis for each outcome measure

Primary outcome: Estrogen Receptor 1 G594a Polymorphism in Women With Menstrual Migraine and Women Without Migraine

Time frame: 6 years. Number. Unit: participants

Measure	1 Menstrual Migraine n = 280	2 No Migraine n = 150
Genotype GG	196	101
Genotype GA	76	43
Genotype AA	8	6

1 Menstrual Migraine vs 2 No Migraine: p = 0.75, Chi-squared

Population analysed: Not all samples were suitable for analysis for each outcome measure

Primary outcome: Estrogen Receptor 1 C325G Polymorphism in Women With Menstrual Migraine and Women Without Migraine

Time frame: 6 years. Number. Unit: participants

Measure	1 Menstrual Migraine n = 280	2 No Migraine n = 154
Genotype CC	155	96
Genotype CG	109	51
Genotype GG	16	7

1 Menstrual Migraine vs 2 No Migraine: p = 0.18, Chi-squared

Population analysed: Not all samples were suitable for analysis for each outcome measure

Primary outcome: Menstrual Cycle Expression of PGR and ESR in Women With Menstrual Migraine and Women Without Migraine

Time frame: 6 years. Mean (Standard Deviation). Unit: number of genes expressed

Measure	1 Menstrual Migraine n = 30	2 No Migraine n = 29
ESR expression in follicular phase	15.98 (NA)	16.73 (NA)
ESR expression in luteal phase	16.58 (NA)	15.62 (NA)
PGR expression in follicular phase	9.62 (NA)	9.80 (NA)
PGR expression in luteal phase	8.95 (NA)	8.69 (NA)

1 Menstrual Migraine vs 2 No Migraine: p >0.05, t-test, 1 sided

Population analysed: Matched pairs of follicular and luteal samples Not all samples were suitable for analysis for each outcome measure

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1 Menstrual Migraine	0 of 0	0 of 0	Not reported
2 No Migraine	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Migraine

RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

E A MacGregor, FFSRH MD principal investigator

Centre for Neuroscience and Trauma, Queen Mary, University of London

Lyn Griffiths, BSc(Hons) PhD principal investigator

Genomics Research Centre Griffith University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Migraine, run by The City of London Migraine Clinic at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progesterone Receptor Gene Polymorphism PROGINS in Women With Menstrual Migraine and Women Without Migraine (time frame: 6 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00904150.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2014.