ESCAPE Migraine Trial

NCT ID: NCT00267371

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2012-03-31

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.

Conditions

Migraine Disorders; Heart Septal Defects, Atrial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Test Arm with Premere investigational

PFO Closure with Premere investigational device.

Group Type: ACTIVE_COMPARATOR

PFO Closure with Premere investigational device.

Intervention Type: DEVICE

PFO Closure with Premere investigational device.

Medical management/current medications

Patients in the control group arm will not receive the medical device and will continue medical management.

Group Type: ACTIVE_COMPARATOR

Medical management/current medications per standard of care by personal physician.

Intervention Type: DRUG

Medical management with current medications per standard of care by personal physician.

Interventions

PFO Closure with Premere investigational device.

PFO Closure with Premere investigational device.

Intervention Type: DEVICE

Medical management/current medications per standard of care by personal physician.

Medical management with current medications per standard of care by personal physician.

Intervention Type: DRUG

Other Intervention Names

Currently prescribed medications.

Eligibility Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Sommer, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

David Dodick, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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 D.C., District of Columbia, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Neurology Associates

Maitland, Florida, United States

Intercoastal Neurology

Sarasota, Florida, United States

Axiom Clinical Research of Florida

Tampa, Florida, United States

Neurology Specialists of Decatur

Decatur, Georgia, United States

Evanston Northwestern HealthCare

Evanston, Illinois, United States

Mid-Atlantic Headache Institute

Pikesville, Maryland, United States

Stroke + NeuroCritical Care Stroke Service

Boston, Massachusetts, United States

New England Regional Headache Center

Worcester, Massachusetts, United States

Providence Hospital & Medical Centers, Inc.

Southfield, Michigan, United States

Mercy Health Research-Neurology

St Louis, Missouri, United States

Radiant Research

St Louis, Missouri, United States

Shore Neurology, PA

Toms River, New Jersey, United States

Upstate Clinical Research, LLC

Albany, New York, United States

MedARK Clinical Research

Morganton, North Carolina, 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

Neurology and Sleep Medicine, P.C.

Bethlehem, Pennsylvania, United States

Drexel University College of Medicine

Philadelphia, Pennsylvania, United States

Clinical Trials Research Services, LLC

Pittsburgh, Pennsylvania, United States

HAN Neurological Associates

Upland, Pennsylvania, United States

Bellaire Neurology, PA

Bellaire, Texas, United States

Texas Neurology, PA

Dallas, Texas, United States

Houston Headache Clinic

Houston, Texas, United States

University of Virginia Neurology

Charlottesville, Virginia, United States

Commonwealth Clinical Research Specialists, Inc.

Richmond, Virginia, United States

Brighton Research Group, LLC

Virginia Beach, Virginia, United States

Swedish Pain & Headache Specialist

Seattle, Washington, United States

Countries

United States

References

Sharan A, Huh B, Narouze S, Trentman T, Mogilner A, Vaisman J, Ordia J, Deer T, Venkatesan L, Slavin K. Analysis of adverse events in the management of chronic migraine by peripheral nerve stimulation. Neuromodulation. 2015 Jun;18(4):305-12; discussion 312. doi: 10.1111/ner.12243. Epub 2014 Oct 14.

Reference Type: DERIVED

PMID: 25313847 (View on PubMed)

Other Identifiers

IDE G050112

Identifier Type: -

Identifier Source: secondary_id

1202-001

Identifier Type: -

Identifier Source: org_study_id