ESCAPE Migraine Trial
- Conditions
- Migraine DisordersHeart Septal Defects, Atrial
- Interventions
- Device: PFO Closure with Premere investigational device.Drug: Medical management/current medications per standard of care by personal physician.
- Registration Number
- NCT00267371
- Lead Sponsor
- Abbott Medical Devices
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 168
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test Arm with Premere investigational PFO Closure with Premere investigational device. PFO Closure with Premere investigational device. Medical management/current medications 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.
- Primary Outcome Measures
Name Time Method The primary effectiveness measure is the decrease in the frequency of migraine headaches. monthly Primary Endpoint 1: Effectiveness 12 months The primary safety endpoint is the rate of major complications monthly
- Secondary Outcome Measures
Name Time Method Secondary Endpoint 1: Effect of Aura on-going Secondary Endpoint 2: Assessment of Procedural Success and Long-Term Device Performance Five years
Trial Locations
- Locations (37)
Alpine Clinical Research Center
🇺🇸Boulder, Colorado, United States
Evanston Northwestern HealthCare
🇺🇸Evanston, Illinois, United States
Upstate Clinical Research, LLC
🇺🇸Albany, New York, United States
New England Regional Headache Center
🇺🇸Worcester, Massachusetts, United States
Stroke + NeuroCritical Care Stroke Service
🇺🇸Boston, Massachusetts, United States
Newport Beach Clinical Research Associates, Inc.
🇺🇸Newport Beach, California, United States
Mayo Clinic Hospital
🇺🇸Scottsdale, Arizona, United States
Medstar Clinical Research at Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Hartford Headache Center
🇺🇸East Hartford, Connecticut, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Neurology Associates
🇺🇸Maitland, Florida, United States
Intercoastal Neurology
🇺🇸Sarasota, Florida, United States
Neurology Specialists of Decatur
🇺🇸Decatur, Georgia, United States
Providence Hospital & Medical Centers, Inc.
🇺🇸Southfield, Michigan, United States
Mercy Health Research-Neurology
🇺🇸Saint Louis, Missouri, United States
Shore Neurology, PA
🇺🇸Toms River, New Jersey, United States
MedARK Clinical Research
🇺🇸Morganton, North Carolina, United States
Neurology and Sleep Medicine, P.C.
🇺🇸Bethlehem, Pennsylvania, United States
Drexel University College of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
HAN Neurological Associates
🇺🇸Upland, Pennsylvania, United States
Clinical Trials Research Services, LLC
🇺🇸Pittsburgh, Pennsylvania, United States
Bellaire Neurology, PA
🇺🇸Bellaire, Texas, United States
Texas Neurology, PA
🇺🇸Dallas, Texas, United States
University of Virginia Neurology
🇺🇸Charlottesville, Virginia, United States
Brighton Research Group, LLC
🇺🇸Virginia Beach, Virginia, United States
Mile High Research Center
🇺🇸Denver, Colorado, United States
Houston Headache Clinic
🇺🇸Houston, Texas, United States
Swedish Pain & Headache Specialist
🇺🇸Seattle, Washington, United States
Advanced Neurosciences Research, LLC
🇺🇸Fort Collins, Colorado, United States
Sutter Institute for Medical Research
🇺🇸Sacramento, California, United States
Axiom Clinical Research of Florida
🇺🇸Tampa, Florida, United States
Clinical Research of Winston-Salem
🇺🇸Winston-Salem, North Carolina, United States
Wake Forest Univ. Health Sciences - BMC
🇺🇸Winston-Salem, North Carolina, United States
Guilford Neurologic Associates, Inc.
🇺🇸Winston-Salem, North Carolina, United States
Commonwealth Clinical Research Specialists, Inc.
🇺🇸Richmond, Virginia, United States
Mid-Atlantic Headache Institute
🇺🇸Pikesville, Maryland, United States
Radiant Research
🇺🇸Saint Louis, Missouri, United States