Study Stopped
Insufficient enrollment
ESCAPE Migraine Trial
Effect of Septal Closure of Atrial PFO on Events of Migraine With Premere: ESCAPE Migraine Trial
2 other identifiers
interventional
168
1 country
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2005
Longer than P75 for phase_3
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 16, 2005
CompletedFirst Posted
Study publicly available on registry
December 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedFebruary 4, 2019
January 1, 2019
6.3 years
December 16, 2005
January 31, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
Secondary Endpoint 1: Effect of Aura
on-going
Secondary Endpoint 2: Assessment of Procedural Success and Long-Term Device Performance
Five years
Study Arms (2)
Test Arm with Premere investigational
ACTIVE COMPARATORPFO Closure with Premere investigational device.
Medical management/current medications
ACTIVE COMPARATORPatients in the control group arm will not receive the medical device and will continue medical management.
Interventions
PFO Closure with Premere investigational device.
Medical management with current medications per standard of care by personal physician.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
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
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
Related Publications (1)
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.
PMID: 25313847DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Sommer, MD
Columbia University
- PRINCIPAL INVESTIGATOR
David Dodick, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2005
First Posted
December 20, 2005
Study Start
November 1, 2005
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
February 4, 2019
Record last verified: 2019-01