ESCAPE Migraine Trial

Condition(s) targeted: Migraine Disorders; Heart Septal Defects, Atrial

Intervention: PFO Closure (Device)

Phase: Phase 2

Status: Recruiting

Sponsored by: St. Jude Medical

Official(s) and/or principal investigator(s):
Robert Sommer, MD, Principal Investigator, Affiliation: Columbia University Medical Center
David Dodick, MD, Principal Investigator, Affiliation: Mayo Clinic Scottsdale

Overall contact:
Clinical Affairs, Phone: 1-888-8STJUDE, Email: cdresearch@sjm.com

The purpose of this 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.

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

Primary Endpoint 1: Effectiveness

The primary effectiveness measure is the decrease in the frequency of migraine headaches.

Primary Endpoint 2: Safety

The primary safety endpoint is the rate of major complications

Secondary outcome:

Secondary Endpoint 1: Effect of Aura

Secondary Endpoint 2: Assessment of Procedural Success and Long-Term Device Performance

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.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Clinical Affairs, Phone: 1-888-8STJUDE, Email: cdresearch@sjm.com

Mayo Clinic, Scottsdale, Arizona 85259, United States; Recruiting
Tiffany Koch, Phone: 480-301-8756
Bart Demaerschalk, MD, Principal Investigator

East Bay Medical Foundation, Berkeley, California 94705, United States; Recruiting
Stephanie Prausnitz, CRC, Phone: 510-849-0417, Ext: 14
Bradley Wrubel, MD, Principal Investigator

LAC + USC Medical Center Neurology, Los Angeles, California 90033, United States; Not yet recruiting
Gayane Begoyan, Phone: 323-226-7383
Soma Sahai Srivastava, MD, Principal Investigator

Mile High Research Center, Denver, Colorado 80218, United States; Recruiting
Amy Klapper, Phone: 303-839-9900, Ext: 2
Jack Klapper, MD, Principal Investigator

Alpine Clinical Research Center, Boulder, Colorado 80304, United States; Not yet recruiting
Deb Shioshita, RN, Phone: 303-443-7229, Ext: 108
Paul Brownstone, MD, Principal Investigator

New England Center for Headache, PC, Stamford, Connecticut 06902, United States; Recruiting
Lori Talento, RN, Phone: 203-322-2748
Fred Shefftel, MD, Principal Investigator

Medstar Clinical Research, Washington, District of Columbia 20010, United States; Not yet recruiting
Tara Higgins, Phone: 202-877-6180
Marc Schlosberg, MD, Principal Investigator

Jacksonville Center for Clinical Research, Jacksonville, Florida 32216, United States; Recruiting
Dorion Kiefer, MA, Phone: 904-732-6666
Daniel Groblewski, MD, Principal Investigator

Neurology Clinical Research, Sunrise, Florida 33351, United States; Recruiting
Dalia Ramos, RMA,CRC, Phone: 954-475-8171, Ext: 143
Richard Singer, MD, Principal Investigator

Intercoastal Neurology, Sarasota, Florida 34232, United States; Recruiting
Mauricio Concha, MD, Phone: 941-330-1864
Mauricio Concha, MD, Principal Investigator

Axiom Clinical Research of Florida, Tampa, Florida 33609, United States; Recruiting
Colleen Killian, Phone: 813-353-9613
Robert Wilson, DO, Principal Investigator

Neurology Associates, Maitland, Florida 32751, United States; Recruiting
Kelly Holley, BS, Phone: 407-647-5996, Ext: 204
Arnaldo Isa, MD, Principal Investigator

Morton Plant Clinical Neurological Specialties, Inc., Clearwater, Florida 33756, United States; Not yet recruiting
Marilyn Fratello, RN, Phone: 727-443-3295
Robert Vollbracht, MD, Principal Investigator

Neurology + Headache Specialists of Atlanta, LLC, Decatur, Georgia 30033, United States; Recruiting
Beverly Johnson-Finley, Phone: 404-294-3040, Ext: 106
Joseph Weissman, MD, Principal Investigator

Walton Headache Center, Augusta, Georgia 30901, United States; Recruiting
Amanda Houston, BS, CCRC, Phone: 706-823-5211
Marc Husid, MD, Principal Investigator

Savannah Neurology, PC, Savannah, Georgia 31405, United States; Recruiting
Linda Poston, RN, CCRC, Phone: 912-790-4861
Eric Pearlman, MD, Principal Investigator

Mount Vernon Clinical Research, LLC, Sandy Springs, Georgia 30328, United States; Not yet recruiting
Jen Cuvo, RN, Phone: 404-843-4413
Gladstone Sellers, MD, Principal Investigator

Glenbrook Hospital, Evanston, Illinois 60201, United States; Not yet recruiting

Mid-Atlantic Headache Institute, Pikesville, Maryland 21208, United States; Not yet recruiting
Michael Moriarity, Phone: 410-602-1999
Marcia Ribeiro, MD, Principal Investigator

Stroke + NeuroCritical Care Stroke Service, Boston, Massachusetts 02114, United States; Not yet recruiting
Christopher Melinosky, Phone: 617-726-8459
F.S. Buonanno, MD, Principal Investigator

MedVadis Research Corporation, Wellesley Hills, Massachusetts 02481, United States; Recruiting
Egilius Spierings, MD, Phone: 781-431-1113
Egilius Spierings, MD, Principal Investigator

New England Regional Headache Center, Worchester, Massachusetts 01605, United States; Recruiting
Deborah Clark, CMA, Phone: 508-890-5112
Herbert Markley, MD, Principal Investigator

Henry Ford Hospital Neurology, Detroit, Michigan 48202, United States; Not yet recruiting
Panayiotis Mitsias, MD, Phone: 313-916-9107
Brian Silver, MD, Sub-Investigator

Michigan Head & Neurological Institute, Ann Arbor, Michigan 48104, United States; Recruiting
Shawn Szalay, Phone: 734-677-6000, Ext: 128
Joel Saper, MD, Principal Investigator

St. Joseph Mercy Hospital / Ann Arbor Neurology, Ann Arbor, Michigan 48106, United States; Recruiting
Jennifer Fowler, RN, CCRC, Phone: 734-712-4062
Susan Hickenbottom, MD, Principal Investigator

Providence & St. John Hospital Neurology, Southfield, Michigan 48075, United States; Not yet recruiting
Jean Kelly, RN, Phone: 248-849-3369
Bruce Kole, MD, Principal Investigator

Clinical Research Insittute, Minneapolis, Minnesota 55402, United States; Recruiting
Cindy Quintard, NRMA, CCRC, Phone: 612-333-2200, Ext: 1360
Gary Berman, MD, Principal Investigator

Mercy Health Research-Neurology, St. Louis, Missouri 63141, United States; Recruiting
Sheri Rocco, LPN, CCRC, Phone: 314-251-8890, Ext: 28139
Timothy Smith, MD, Principal Investigator

Radiant Research, St. Louis, Missouri 63141, United States; Recruiting
Candace Grasse, RN, Phone: 314-692-2100
Bruce Berwald, MD, Principal Investigator

Midwest Clinical Research, St. Louis, Missouri 63141, United States; Not yet recruiting
Laurie Schmidt, RN, Phone: 314-991-5117
Robert Onder, MD, Principal Investigator

Neurology of Bergen County, Richwood, New Jersey 07450, United States; Recruiting
Lillian Warnock, RN, Phone: 201-444-0868, Ext: 268
Kenneth Levin, MD, Phone: 201-444-0868, Ext: 275
Kenneth A Levin, MD, Principal Investigator

Upstate Clinical Research, LLC, Albany, New York 12205, United States; Recruiting
Myra Edmunds, Phone: 518-533-1546
Christopher Calder, MD, Principal Investigator

Elkind Headache Center, Mount Vernon, New York 10550, United States; Recruiting
Arthur Elkind, MD, Phone: 914-677-2230
Gary Ishkanian, MD, Phone: 914-667-2230
Arthur Elkind, MD, Principal Investigator

Montefiore Headache Unit, Bronx, New York 10461, United States; Recruiting
Amy Tsang, Phone: 718-405-8363
Richard Lipton, MD, Principal Investigator

New York Headache Center, New York City, New York 10021, United States; Recruiting
Elizabeth Jett, Phone: 212-794-3550, Ext: 15
Alexander Mauskop, MD, Principal Investigator

DENT Neurologic Institute, Amherst, New York 14226, United States; Recruiting
Malika Pasha, MBA, CCRC, Phone: 716-250-2028
Laszlo Mechtler, Md, Principal Investigator

Clinical Research of Winston-Salem, Winston-Salem, North Carolina 27103, United States; Recruiting
Natalie Guynn, LPN, CRC, Phone: 336-794-3273
John Porter, MD, Principal Investigator

Wake Forest University Neurology, Winston-Salem, North Carolina 27103, United States; Not yet recruiting
Emily Smith, Phone: 336-716-2133
Kerstin Betterman, MD, Principal Investigator

Guilford Neurologic Associates, Inc., Winston-Salem, North Carolina 27103, United States; Recruiting
Natalie Guynn, LPN,CRC, Phone: 336-794-3273
Michael Reynolds, MD, Principal Investigator

MedARK Clinical Research, Morganton, North Carolina 28655, United States; Not yet recruiting
Tammy Lee, CCRC, Phone: 828-437-8282
Kurian Abraham, MD, Principal Investigator

HAN Neurological Associates, Upland, Pennsylvania 19013, United States; Not yet recruiting
Susan Curry, RN, Phone: 610-874-8323
Kimberly Atkinson, DO, Principal Investigator

Hahnemann Hospital Neurology, Philadelphia, Pennsylvania 19107, United States; Recruiting
Daryl Spruill, RN, Phone: 215-762-1528
David Tabby, DO, Principal Investigator

CNS Research, Inc., East Providence, Rhode Island 02916, United States; Not yet recruiting
Patricia Epple, RN, Phone: 800-707-6013
Norman Gordon, MD, Principal Investigator

Radiant Research - Greer, Greer, South Carolina 29651, United States; Not yet recruiting
Denise Rishel, Phone: 864-877-9239, Ext: 230
William Ellison, MD, Principal Investigator

Texas Neurology, PA, Dallas, Texas 75214, United States; Recruiting
Shari L. Hand, Phone: 214-827-3610, Ext: 226
Steven Herzog, MD, Principal Investigator

Brighton Research Group, LLC, Virginia Beach, Virginia 23452, United States; Recruiting
Michelle Spady, BS, CCRP, Phone: 757-368-0672
Neil Pugach, MD, Principal Investigator

University of Virginia Neurology, Charlottesville, Virginia 22903, United States; Recruiting
Paula Damgaard, RN, Phone: 434-243-5420
Ivan Login, MD, Principal Investigator

ESCAPE Migraine Clinical Trial Website

Last updated: February 27, 2007