ESCAPE Migraine Trial
Migraine Disorders, Heart Septal Defects, Atrial
About this trial
This is an interventional treatment trial for Migraine Disorders focused on measuring Migraine headache, Patent Foramen Ovale, Patent Foramen Ovale Closure
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic Hospital
- Newport Beach Clinical Research Associates, Inc.
- Sutter Institute for Medical Research
- Alpine Clinical Research Center
- Mile High Research Center
- Advanced Neurosciences Research, LLC
- Hartford Headache Center
- Medstar Clinical Research at Washington Hospital Center
- Jacksonville Center for Clinical Research
- Neurology Associates
- Intercoastal Neurology
- Axiom Clinical Research of Florida
- Neurology Specialists of Decatur
- Evanston Northwestern HealthCare
- Mid-Atlantic Headache Institute
- Stroke + NeuroCritical Care Stroke Service
- New England Regional Headache Center
- Providence Hospital & Medical Centers, Inc.
- Mercy Health Research-Neurology
- Radiant Research
- Shore Neurology, PA
- Upstate Clinical Research, LLC
- MedARK Clinical Research
- Clinical Research of Winston-Salem
- Wake Forest Univ. Health Sciences - BMC
- Guilford Neurologic Associates, Inc.
- Neurology and Sleep Medicine, P.C.
- Drexel University College of Medicine
- Clinical Trials Research Services, LLC
- HAN Neurological Associates
- Bellaire Neurology, PA
- Texas Neurology, PA
- Houston Headache Clinic
- University of Virginia Neurology
- Commonwealth Clinical Research Specialists, Inc.
- Brighton Research Group, LLC
- Swedish Pain & Headache Specialist
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Test Arm with Premere investigational
Medical management/current medications
PFO Closure with Premere investigational device.
Patients in the control group arm will not receive the medical device and will continue medical management.