NCT00267371|TerminatedPhase 3DMC
Study Stopped
Insufficient enrollment
ESCAPE Migraine Trial
Effect of Septal Closure of Atrial PFO on Events of Migraine With Premere: ESCAPE Migraine Trial
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Sponsor study identifier
Secondary identifiers
interventional
168
1 country
37
Study Start
November 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2012
Actual (reported)Study Completion
March 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2005
Date type not reportedThis date has not been verified as actual or estimated.
December 16, 2005
Actual (reported)December 20, 2005
Actual (reported)March 2012
Actual (reported)March 2012
Actual (reported)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 Endpoint 1: Effect of Aura
on-going
Secondary Endpoint 2: Assessment of Procedural Success and Long-Term Device Performance
Five years
PFO Closure with Premere investigational device.
Patients in the control group arm will not receive the medical device and will continue medical management.
PFO Closure with Premere investigational device.
Medical management with current medications per standard of care by personal physician.
Mayo Clinic Hospital
Scottsdale, Arizona, 85054, United States
Newport Beach Clinical Research Associates, Inc.
Newport Beach, California, 92660, United States
Sutter Institute for Medical Research
Sacramento, California, 95816, United States
Alpine Clinical Research Center
Boulder, Colorado, 80304, United States
Mile High Research Center
Denver, Colorado, 80218, United States
Advanced Neurosciences Research, LLC
Fort Collins, Colorado, 80528, United States
Hartford Headache Center
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.
Robert Sommer, MD
Columbia University
David Dodick, MD
Mayo Clinic
168 participants (actual enrollment reported by the registry).
First Submitted
December 16, 2005
First Posted
December 20, 2005
Study Start
November 2005
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
East Hartford, Connecticut, 06118, United States
Medstar Clinical Research at Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Neurology Associates
Maitland, Florida, 32751, United States
Intercoastal Neurology
Sarasota, Florida, 34232, United States
Axiom Clinical Research of Florida
Tampa, Florida, 33609, United States
Neurology Specialists of Decatur
Decatur, Georgia, 30033, United States
Evanston Northwestern HealthCare
Evanston, Illinois, 60201, United States
Mid-Atlantic Headache Institute
Pikesville, Maryland, 21208, United States
Stroke + NeuroCritical Care Stroke Service
Boston, Massachusetts, 02114, United States
New England Regional Headache Center
Worcester, Massachusetts, 01605, United States
Providence Hospital & Medical Centers, Inc.
Southfield, Michigan, 48075, United States
Mercy Health Research-Neurology
St Louis, Missouri, 63141, United States
Radiant Research
St Louis, Missouri, 63141, United States
Shore Neurology, PA
Toms River, New Jersey, 08755, United States
Upstate Clinical Research, LLC
Albany, New York, 12205, United States
MedARK Clinical Research
Morganton, North Carolina, 28655, United States
Clinical Research of Winston-Salem
Winston-Salem, North Carolina, 27103, United States
Wake Forest Univ. Health Sciences - BMC
Winston-Salem, North Carolina, 27157, United States
Guilford Neurologic Associates, Inc.
Winston-Salem, North Carolina, 27401, United States
Neurology and Sleep Medicine, P.C.
Bethlehem, Pennsylvania, 18015, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102, United States
Clinical Trials Research Services, LLC
Pittsburgh, Pennsylvania, 15206, United States
HAN Neurological Associates
Upland, Pennsylvania, 19013, United States
Bellaire Neurology, PA
Bellaire, Texas, 77401, United States
Texas Neurology, PA
Dallas, Texas, 75214, United States
Houston Headache Clinic
Houston, Texas, 77004, United States
University of Virginia Neurology
Charlottesville, Virginia, 22903, United States
Commonwealth Clinical Research Specialists, Inc.
Richmond, Virginia, 23233, United States
Brighton Research Group, LLC
Virginia Beach, Virginia, 23452, United States
Swedish Pain & Headache Specialist
Seattle, Washington, 98104, United States
Primary Completion
March 2012
Actual (reported)Study Completion
March 2012
Actual (reported)Last Updated
February 4, 2019
Record last verified: 2019-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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