ESCAPE Migraine Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Septal Closure of Atrial PFO on Events of Migraine With Premere: ESCAPE Migraine Trial

Conditions
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Migraine Disorders, Heart Septal Defects, Atrial

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test Arm with Premere investigational<br>PFO Closure with Premere investigational device. | Device: PFO Closure with Premere investigational device.<br>* PFO Closure with Premere investigational device.<br>|
| Active Comparator: Medical management/current medications<br>Patients in the control group arm will not receive the medical device and will continue medical management. | Drug: Medical management/current medications per standard of care by personal physician.<br>* Medical management with current medications per standard of care by personal physician.<br>* Other names: Currently prescribed medications.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Endpoint 1: Effectiveness |  | 12 months | 
| The primary effectiveness measure is the decrease in the frequency of migraine headaches. |  | monthly | 
| The primary safety endpoint is the rate of major complications |  | monthly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Endpoint 1: Effect of Aura |  | on-going | 
| Secondary Endpoint 2: Assessment of Procedural Success and Long-Term Device Performance |  | Five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine headache, Patent Foramen Ovale, Patent Foramen Ovale Closure