MigrainePhase 2PRIMANCT00505570
PRIMA PFO Migraine Trial
A Phase 2 study testing AMPLATZER® PFO Occluder Device in people with Migraine and Migraine With Aura, run by Abbott Medical Devices at 17 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale (PFO, a slit-like opening between the right and left upper chambers (atria) of the heart which normally closes at or soon after birth) who are randomized to either undergo closure of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine, Migraine With Aura, Patent Foramen Ovale
- What is being tested?
- AMPLATZER® PFO Occluder Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 17 sitesin 4 countries
- Study dates
- May 2006to Feb 2013
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are age 18 to 65
- Subjects who have migraine headaches with aura diagnosed by a doctor
- Subjects who have not responded to or cannot take common migraine preventive medications
Who cannot join
- Subjects with a clinical history of stroke
- Subjects who cannot take aspirin and clopidogrel (Plavix)
- Subjects who are pregnant or desire to become pregnant within the next year
Trial locations and contacts
17 sites in 4 countries.
17 sites in 4 countries
Canada7 sites
University of Calgary- Foothills Hospital
Calgary, Alberta, T2N 2T9
Alberta Health Services and the University of Alberta
Edmonton, Alberta
Institut de Cardiologie de Montreal
Montreal, Quebec, H1T 1C8
University of Ottawa
Ottawa, Ontario, K1H 1A2
Centre Hospitalier Universitaire de Québec
Québec, Quebec, G1V 4G5
Davisville Medical Center
Toronto, Ontario, M4S 1Y2
University of British Columbia
Vancouver, British Columbia, V6Z 1Y6
Germany5 sites
Unfallkrankenhaus Berlin
Berlin, 12683
Martin-Luther-University Halle-Wittenberg
Halle, 06120
Universitätsklinikum Hamburg
Hamburg, 20246
Neurologisch-verhaltensmedizinische Schmerzklinik Kiel
Kiel, 24149
Universitätsklinikum Münster
Münster, 48129
United Kingdom3 sites
Royal Sussex County Hospital
Brighton, BN2 5BE
St. Mary's Hospital Imperial College Healthcare NHS Trust
London, W2 1NY
South Manchester University Hospital
Manchester, M23 9LT
Switzerland2 sites
Swiss Cardiovascular Center Bern
Bern, 3010
Kopfwehzentrum Hirslanden Zürich
Zurich, 8088
About this study
Official title: Percutaneous Closure of Patent Foramen Ovale In Migraine With Aura - A Randomized Prospective Study (Prima Trial)
The purpose of this study is to evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale (PFO, a slit-like opening between the right and left upper chambers (atria) of the heart which normally closes at or soon after birth) who are randomized to either undergo closure of the patent foramen ovale or continue with standard medical management.
Read the detailed description
The purpose of this study is to evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale (PFO, a slit-like opening between the right and left upper chambers (atria) of the heart which normally closes at or soon after birth) who are randomized to either undergo closure of the patent foramen ovale or continue with standard medical management.
- Conditions
- Migraine, Migraine With Aura, Patent Foramen Ovale, PFO
- Being tested
- AMPLATZER® PFO Occluder Device
- Keywords
- Migraine, Migraine with aura, Patent foramen ovale, PFO
- Medical subject headings
- Migraine Disorders, Migraine with Aura, Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMPLATZER® PFO Occluder DeviceDevice
PFO device closure
| Study group | Role | What they receive |
|---|---|---|
| Medical Management | No intervention | Not described |
| PFO Closure | Experimental | Not described Receives: Device: AMPLATZER® PFO Occluder Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine headache frequency
Measured: 12 months
Secondary outcomes (1)
Responder rate; Acute migraine medication use; Quality of life evaluations; Effects of Anti-thrombotic medications; Adverse events; PFO Closure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2007 (estimated)
- Study startMay 2006
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prima Trial Steering Committee, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505570
- Sponsor's protocol ID
- AGA010E
- Acronym
- PRIMA
- Status last verified
- Feb 2019
- First submitted
- 20 Jul 2007
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mattle HP, Evers S, Hildick-Smith D, Becker WJ, Baumgartner H, Chataway J, Gawel M, Gobel H, Heinze A, Horlick E, Malik I, Ray S, Zermansky A, Findling O, Windecker S, Meier B. Percutaneous closure of patent foramen ovale in migraine with aura, a randomized controlled trial. Eur Heart J. 2016 Jul 7;37(26):2029-36. doi: 10.1093/eurheartj/ehw027. Epub 2016 Feb 22.
PubMed 26908949
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Closure of Patent Foramen Ovale In Migraine With Aura - A Randomized Prospective Study (Prima Trial)
- ClinicalTrials.gov ID
- NCT00505570
- Acronym / sponsor ID
- PRIMA / AGA010E
- Conditions
- Migraine, Migraine With Aura, Patent Foramen Ovale, PFO
- Keywords
- Migraine, Migraine with aura, Patent foramen ovale, PFO
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 23 Jul 2007 (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 evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale (PFO, a slit-like opening between the right and left upper chambers (atria) of the heart which normally closes at or soon after birth) who are randomized to either undergo closure of the patent foramen ovale or continue with standard medical management.
Detailed description
The purpose of this study is to evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale (PFO, a slit-like opening between the right and left upper chambers (atria) of the heart which normally closes at or soon after birth) who are randomized to either undergo closure of the patent foramen ovale or continue with standard medical management.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical Management | No intervention | – |
| PFO Closure | Experimental | Device: AMPLATZER® PFO Occluder Device |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects who are age 18 to 65
- Subjects who have migraine headaches with aura diagnosed by a doctor
- Subjects who have not responded to or cannot take common migraine preventive medications
Key exclusion criteria (3 listed)
- Subjects with a clinical history of stroke
- Subjects who cannot take aspirin and clopidogrel (Plavix)
- Subjects who are pregnant or desire to become pregnant within the next year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMPLATZER® PFO Occluder DevicePFO device closure | Device | PFO Closure |
Primary outcome
Migraine headache frequency
Time frame: 12 months
1 secondary outcome
Responder rate; Acute migraine medication use; Quality of life evaluations; Effects of Anti-thrombotic medications; Adverse events; PFO Closure
Time frame: 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Derived from this study: PubMed 26908949Mattle HP, Evers S, Hildick-Smith D, Becker WJ, Baumgartner H, Chataway J, Gawel M, Gobel H, Heinze A, Horlick E, Malik I, Ray S, Zermansky A, Findling O, Windecker S, Meier B. Percutaneous closure of patent foramen ovale in migraine with aura, a randomized controlled trial. Eur Heart J. 2016 Jul 7;37(26):2029-36. doi: 10.1093/eurheartj/ehw027. Epub 2016 Feb 22.
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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.
Prima Trial Steering Committee study chair
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMPLATZER® PFO Occluder Device in people with Migraine and Migraine With Aura, run by Abbott Medical Devices at 17 sites in 4 countries.
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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Canada, Germany, United Kingdom, Switzerland. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Migraine headache frequency (time frame: 12 months). 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 NCT00505570, which also lists 1 linked publication.
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 Feb 2019.