Migraine With AuraWOMANNCT02047695
Women With Migraine With Aura Neuroimaging Study
An observational study of Migraine With Aura, run by Odense University Hospital.
Trial summary
The purpose of this study is to investigate whether a particular form of migraine, migraine with aura, is associated with structural changes in the brain Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Migraine With Aura
- How many people
- 345 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Selected from a population-based twin registry
Who may be able to join
- female
- case (migraine with aura), co-twin to case, or control (migraine-free)
- residency in Denmark
- no severe neurological (vascular, neurodegenerative or neuroinflammatory) disorders, or other somatic or psychiatric disorders
Who cannot join
- male
- residency outside Denmark
- registered in Civil Registry as not to be contacted by researchers
- severe neurological (vascular, neurodegenerative or neuroinflammatory) disorders, or other somatic or psychiatric disorders
- mobile metal parts or other contraindication for MRI
- weight of 130+ kilograms
Show all 10Show fewer
- pregnancy
- subjects that wished not to be informed about abnormal findings on MRI
- chronic tension-type headache, medication overuse headache, or cluster headache (diagnosed through physician interview)
- frequent tension-type headache (control group only, self-reported or diagnosed through physician interview)
About this study
Official title: Women With Migraine With Aura Neuroimaging (WOMAN) Study: A Population-based Study of Danish Twins
The purpose of this study is to investigate whether a particular form of migraine, migraine with aura, is associated with structural changes in the brain
- Conditions
- Migraine With Aura
- Keywords
- migraine with aura, migraine, case-control study, magnetic resonance imaging, brain diseases
- Medical subject headings
- Migraine with Aura, Migraine Disorders, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Migraine with aura | Participants with migraine with aura (cases), their co-twins, and unrelated migraine-free twins (controls) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of white matter hyperintensities or subclinical ischaemic stroke confirmed by MRI
Measured: At time of MRI
Secondary outcomes (1)
Evidence of other structural and functional changes in brain
Measured: At time of MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startFeb 2011
- Primary completionApr 2015
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine With AuraStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen, Copenhagen University Hospital, Hvidovre, University of Southern Denmark
- Responsible party
- Principal investigator, David Gaist, Odense University Hospital
- Investigators
- David Gaist, MD, PhD, Principal investigator, Department of Neurology, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047695
- Sponsor's protocol ID
- S-20100126
- Acronym
- WOMAN
- Status last verified
- Apr 2017
- First submitted
- 26 Jan 2014
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women With Migraine With Aura Neuroimaging (WOMAN) Study: A Population-based Study of Danish Twins
- ClinicalTrials.gov ID
- NCT02047695
- Acronym / sponsor ID
- WOMAN / S-20100126
- Conditions
- Migraine With Aura
- Keywords
- migraine with aura, migraine, case-control study, magnetic resonance imaging, brain diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen, Copenhagen University Hospital, Hvidovre, University of Southern Denmark
- Study start
- Feb 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate whether a particular form of migraine, migraine with aura, is associated with structural changes in the brain
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Migraine with aura | – | –Participants with migraine with aura (cases), their co-twins, and unrelated migraine-free twins (controls) |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Selected from a population-based twin registry
Key inclusion criteria (4 listed)
- female
- case (migraine with aura), co-twin to case, or control (migraine-free)
- residency in Denmark
- no severe neurological (vascular, neurodegenerative or neuroinflammatory) disorders, or other somatic or psychiatric disorders
Key exclusion criteria (10 listed)
- male
- residency outside Denmark
- registered in Civil Registry as not to be contacted by researchers
- severe neurological (vascular, neurodegenerative or neuroinflammatory) disorders, or other somatic or psychiatric disorders
- mobile metal parts or other contraindication for MRI
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
Evidence of white matter hyperintensities or subclinical ischaemic stroke confirmed by MRI
Time frame: At time of MRI
1 secondary outcome
Evidence of other structural and functional changes in brain
Time frame: At time of MRI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
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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.
David Gaist, MD, PhD principal investigator
Department of Neurology, Odense University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine With Aura, run by Odense University Hospital.
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 4 inclusion and 10 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 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evidence of white matter hyperintensities or subclinical ischaemic stroke confirmed by MRI (time frame: At time of MRI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2017.