Migraine DisordersPhase 3NCT00267371
ESCAPE Migraine Trial
A Phase 3 study testing PFO Closure with Premere investigational device. in people with Migraine Disorders and Heart Septal Defects, Atrial, run by Abbott Medical Devices at 37 sites in United States.
Trial summary
The purpose of this two arm controlled double-blind study is to determine the safety and effectiveness of PFO closure (closing a hole in the wall of the heart) in reducing the frequency of migraine headaches, in patients who experience migraine headaches and have a PFO, compared to medical therapy alone. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Migraine Disorders, Heart Septal Defects, Atrial
- What is being tested?
- PFO Closure with Premere investigational device.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 37 sitesUnited States
- Study dates
- Nov 2005to Mar 2012
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Major Inclusion Criteria:
- Patient must be between the ages of 18 and 70;
- Patient must have a migraine history and demonstrate a refractoriness to medical treatment;
- Patient must have a Patent Foramen Ovale (PFO);
- Patient must be willing and able to give informed consent and complete required follow-up visits.
Major Exclusion Criteria:
- Patient has any medical condition or receives any medication that would preclude participation in the trial
- Patient is enrolled or intends to participate in another clinical study (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during the study or within four weeks prior to his/her enrollment in the study.
- Patient is pregnant, or intends to become pregnant during the trial period
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United States37 sites
Upstate Clinical Research, LLC
Albany, New York, 12205
Bellaire Neurology, PA
Bellaire, Texas, 77401
Neurology and Sleep Medicine, P.C.
Bethlehem, Pennsylvania, 18015
Stroke + NeuroCritical Care Stroke Service
Boston, Massachusetts, 02114
Alpine Clinical Research Center
Boulder, Colorado, 80304
University of Virginia Neurology
Charlottesville, Virginia, 22903
Texas Neurology, PA
Dallas, Texas, 75214
Neurology Specialists of Decatur
Decatur, Georgia, 30033
Mile High Research Center
Denver, Colorado, 80218
Hartford Headache Center
East Hartford, Connecticut, 06118
Evanston Northwestern HealthCare
Evanston, Illinois, 60201
Advanced Neurosciences Research, LLC
Fort Collins, Colorado, 80528
Houston Headache Clinic
Houston, Texas, 77004
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Neurology Associates
Maitland, Florida, 32751
MedARK Clinical Research
Morganton, North Carolina, 28655
Newport Beach Clinical Research Associates, Inc.
Newport Beach, California, 92660
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
Mid-Atlantic Headache Institute
Pikesville, Maryland, 21208
Clinical Trials Research Services, LLC
Pittsburgh, Pennsylvania, 15206
Commonwealth Clinical Research Specialists, Inc.
Richmond, Virginia, 23233
Sutter Institute for Medical Research
Sacramento, California, 95816
Intercoastal Neurology
Sarasota, Florida, 34232
Mayo Clinic Hospital
Scottsdale, Arizona, 85054
Swedish Pain & Headache Specialist
Seattle, Washington, 98104
Providence Hospital & Medical Centers, Inc.
Southfield, Michigan, 48075
Mercy Health Research-Neurology
St Louis, Missouri, 63141
Radiant Research
St Louis, Missouri, 63141
Axiom Clinical Research of Florida
Tampa, Florida, 33609
Shore Neurology, PA
Toms River, New Jersey, 08755
HAN Neurological Associates
Upland, Pennsylvania, 19013
Brighton Research Group, LLC
Virginia Beach, Virginia, 23452
Medstar Clinical Research at Washington Hospital Center
Washington D.C., District of Columbia, 20010
Clinical Research of Winston-Salem
Winston-Salem, North Carolina, 27103
Wake Forest Univ. Health Sciences - BMC
Winston-Salem, North Carolina, 27157
Guilford Neurologic Associates, Inc.
Winston-Salem, North Carolina, 27401
New England Regional Headache Center
Worcester, Massachusetts, 01605
About this study
Official title: Effect of Septal Closure of Atrial PFO on Events of Migraine With Premere: ESCAPE Migraine Trial
The purpose of this two arm controlled double-blind study is to determine the safety and effectiveness of PFO closure (closing a hole in the wall of the heart) in reducing the frequency of migraine headaches, in patients who experience migraine headaches and have a PFO, compared to medical therapy alone.
Read the detailed description
Migraine headache is a neurological disorder characterized by chronic and disabling headache. Approximately 10-12% of humans, comprising some 28 million Americans, suffer from this disorder. Despite continual advances in medical management of migraine, many sufferers continue to experience frequent and disabling attacks despite appropriate medical therapy. Preventative medications, such as anti-epileptic drugs, anti-depressants, and beta-blockers, while effective for many patients, have side-effect profiles that preclude use in many patients. In the past decade, there has been growing evidence that patients with migraine, particularly those with aura, are more likely to have a patent foramen ovale.
A patent foramen ovale (PFO) is a persistent, flap-like opening in the wall of the heart, between the right and left atrium. Typically, this opening closes shortly after birth, however, in some people, it remains open.
While there is currently no proof for cause-effect relationship, several recent studies have confirmed a strong association between the presence of PFO and migraine with aura.
Comparison: This clinical study will compare PFO closure with medical therapy alone for the treatment of migraine headaches.
- Conditions
- Migraine Disorders, Heart Septal Defects, Atrial
- Being tested
- PFO Closure with Premere investigational device., Medical management/current medications per standard of care by personal physician.
- Keywords
- Migraine headache, Patent Foramen Ovale, Patent Foramen Ovale Closure
- Medical subject headings
- Migraine Disorders, Heart Septal Defects, Atrial, Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFO Closure with Premere investigational device.Device
PFO Closure with Premere investigational device.
Medical management/current medications per standard of care by personal physician.Drug
Also called Currently prescribed medications.
Medical management with current medications per standard of care by personal physician.
| Study group | Role | What they receive |
|---|---|---|
| Test Arm with Premere investigational | Active comparator | PFO Closure with Premere investigational device. Receives: Device: PFO Closure with Premere investigational device. |
| Medical management/current medications | Active comparator | Patients in the control group arm will not receive the medical device and will continue medical management. Receives: Drug: Medical management/current medications per standard of care by personal physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint 1: Effectiveness
Measured: 12 months
The primary effectiveness measure is the decrease in the frequency of migraine headaches.
Measured: monthly
The primary safety endpoint is the rate of major complications
Measured: monthly
Secondary outcomes (2)
Secondary Endpoint 1: Effect of Aura
Measured: on-going
Secondary Endpoint 2: Assessment of Procedural Success and Long-Term Device Performance
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2005 (estimated)
- Study startNov 2005
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: Insufficient enrollment
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 Migraine DisordersStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Sommer, MD, Principal investigator, Columbia UniversityDavid Dodick, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00267371
- Sponsor's protocol ID
- 1202-001
- Other IDs
- IDE G050112
- Status last verified
- Jan 2019
- First submitted
- 16 Dec 2005
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sharan A, Huh B, Narouze S, Trentman T, Mogilner A, Vaisman J, Ordia J, Deer T, Venkatesan L, Slavin K. Analysis of adverse events in the management of chronic migraine by peripheral nerve stimulation. Neuromodulation. 2015 Jun;18(4):305-12; discussion 312. doi: 10.1111/ner.12243. Epub 2014 Oct 14.
PubMed 25313847
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
- Effect of Septal Closure of Atrial PFO on Events of Migraine With Premere: ESCAPE Migraine Trial
- ClinicalTrials.gov ID
- NCT00267371
- Acronym / sponsor ID
- 1202-001
- Conditions
- Migraine Disorders, Heart Septal Defects, Atrial
- Keywords
- Migraine headache, Patent Foramen Ovale, Patent Foramen Ovale Closure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 20 Dec 2005 (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 two arm controlled double-blind study is to determine the safety and effectiveness of PFO closure (closing a hole in the wall of the heart) in reducing the frequency of migraine headaches, in patients who experience migraine headaches and have a PFO, compared to medical therapy alone.
Detailed description
Migraine headache is a neurological disorder characterized by chronic and disabling headache. Approximately 10-12% of humans, comprising some 28 million Americans, suffer from this disorder. Despite continual advances in medical management of migraine, many sufferers continue to experience frequent and disabling attacks despite appropriate medical therapy. Preventative medications, such as anti-epileptic drugs, anti-depressants, and beta-blockers, while effective for many patients, have side-effect profiles that preclude use in many patients. In the past decade, there has been growing evidence that patients with migraine, particularly those with aura, are more likely to have a patent foramen ovale.
A patent foramen ovale (PFO) is a persistent, flap-like opening in the wall of the heart, between the right and left atrium. Typically, this opening closes shortly after birth, however, in some people, it remains open.
While there is currently no proof for cause-effect relationship, several recent studies have confirmed a strong association between the presence of PFO and migraine with aura.
Comparison: This clinical study will compare PFO closure with medical therapy alone for the treatment of migraine headaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Arm with Premere investigational | Active comparator | Device: PFO Closure with Premere investigational device.PFO Closure with Premere investigational device. |
| Medical management/current medications | Active comparator | Drug: Medical management/current medications per standard of care by personal physician.Patients in the control group arm will not receive the medical device and will continue medical management. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| PFO Closure with Premere investigational device.PFO Closure with Premere investigational device. | Device | Test Arm with Premere investigational |
| Medical management/current medications per standard of care by personal physician.Also: Currently prescribed medications.Medical management with current medications per standard of care by personal physician. | Drug | Medical management/current medications |
Primary outcome
Primary Endpoint 1: Effectiveness
Time frame: 12 months
The primary effectiveness measure is the decrease in the frequency of migraine headaches.
Time frame: monthly
The primary safety endpoint is the rate of major complications
Time frame: monthly
2 secondary outcomes
Secondary Endpoint 1: Effect of Aura
Time frame: on-going
Secondary Endpoint 2: Assessment of Procedural Success and Long-Term Device Performance
Time frame: Five years
Results and safety
The study was stopped early (reason given: Insufficient enrollment). 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 25313847Sharan A, Huh B, Narouze S, Trentman T, Mogilner A, Vaisman J, Ordia J, Deer T, Venkatesan L, Slavin K. Analysis of adverse events in the management of chronic migraine by peripheral nerve stimulation. Neuromodulation. 2015 Jun;18(4):305-12; discussion 312. doi: 10.1111/ner.12243. Epub 2014 Oct 14.
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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.
Robert Sommer, MD principal investigator
Columbia University
David Dodick, MD principal investigator
Mayo Clinic
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PFO Closure with Premere investigational device. in people with Migraine Disorders and Heart Septal Defects, Atrial, run by Abbott Medical Devices at 37 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 37 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 (reason given: Insufficient enrollment). 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?
Primary Endpoint 1: Effectiveness (time frame: 12 months). The study lists 3 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 NCT00267371, 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.