ESCAPE Migraine Trial

Phase 3

Terminated

Interventions: Device: PFO Closure with Premere investigational device.
Drug: Medical management/current medications per standard of care by personal physician.

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

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

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
Primary Endpoint 1: Effectiveness	12 months
The primary safety endpoint is the rate of major complications	monthly
The primary effectiveness measure is the decrease in the frequency of migraine headaches.	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

Locations (37): Mayo Clinic Hospital
🇺🇸
Scottsdale, Arizona, United States
Newport Beach Clinical Research Associates, Inc.
🇺🇸
Newport Beach, California, United States
Sutter Institute for Medical Research
🇺🇸
Sacramento, California, United States
Alpine Clinical Research Center
🇺🇸
Boulder, Colorado, United States
Mile High Research Center
🇺🇸
Denver, Colorado, United States
Advanced Neurosciences Research, LLC
🇺🇸
Fort Collins, Colorado, United States
Hartford Headache Center
🇺🇸
East Hartford, Connecticut, United States
Medstar Clinical Research at Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
Jacksonville Center for Clinical Research
🇺🇸
Jacksonville, Florida, United States
Neurology Associates
🇺🇸
Maitland, Florida, United States
Scroll for more (27 remaining)
Mayo Clinic Hospital
🇺🇸Scottsdale, Arizona, United States