ESCAPE Migraine Trial

January 31, 2019 updated by: Abbott Medical Devices

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

168

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85054
        • Mayo Clinic Hospital
    • California
      • Newport Beach, California, United States, 92660
        • Newport Beach Clinical Research Associates, Inc.
      • Sacramento, California, United States, 95816
        • Sutter Institute for Medical Research
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Alpine Clinical Research Center
      • Denver, Colorado, United States, 80218
        • Mile High Research Center
      • Fort Collins, Colorado, United States, 80528
        • Advanced Neurosciences Research, LLC
    • Connecticut
      • East Hartford, Connecticut, United States, 06118
        • Hartford Headache Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Medstar Clinical Research at Washington Hospital Center
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Maitland, Florida, United States, 32751
        • Neurology Associates
      • Sarasota, Florida, United States, 34232
        • Intercoastal Neurology
      • Tampa, Florida, United States, 33609
        • Axiom Clinical Research of Florida
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Neurology Specialists of Decatur
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Evanston Northwestern Healthcare
    • Maryland
      • Pikesville, Maryland, United States, 21208
        • Mid-Atlantic Headache Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Stroke + NeuroCritical Care Stroke Service
      • Worcester, Massachusetts, United States, 01605
        • New England Regional Headache Center
    • Michigan
      • Southfield, Michigan, United States, 48075
        • Providence Hospital & Medical Centers, Inc.
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Mercy Health Research-Neurology
      • Saint Louis, Missouri, United States, 63141
        • Radiant Research
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Shore Neurology, PA
    • New York
      • Albany, New York, United States, 12205
        • Upstate Clinical Research, LLC
    • North Carolina
      • Morganton, North Carolina, United States, 28655
        • Medark Clinical Research
      • Winston-Salem, North Carolina, United States, 27103
        • Clinical Research of Winston-Salem
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Univ. Health Sciences - BMC
      • Winston-Salem, North Carolina, United States, 27401
        • Guilford Neurologic Associates, Inc.
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Neurology and Sleep Medicine, P.C.
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University College of Medicine
      • Pittsburgh, Pennsylvania, United States, 15206
        • Clinical Trials Research Services, LLC
      • Upland, Pennsylvania, United States, 19013
        • HAN Neurological Associates
    • Texas
      • Bellaire, Texas, United States, 77401
        • Bellaire Neurology, PA
      • Dallas, Texas, United States, 75214
        • Texas Neurology, PA
      • Houston, Texas, United States, 77004
        • Houston Headache Clinic
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Neurology
      • Richmond, Virginia, United States, 23233
        • Commonwealth Clinical Research Specialists, Inc.
      • Virginia Beach, Virginia, United States, 23452
        • Brighton Research Group, LLC
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Pain & Headache Specialist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Test Arm with Premere investigational
PFO Closure with Premere investigational device.
Device: PFO Closure with Premere investigational device.
PFO Closure with Premere investigational device.
Active Comparator: Medical management/current medications
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.
Medical management with current medications per standard of care by personal physician.
Other Names:
  • Currently prescribed medications.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

December 16, 2005

First Submitted That Met QC Criteria

December 16, 2005

First Posted (Estimate)

December 20, 2005

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1202-001
  • IDE G050112

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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