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

Status: Terminated
Location: See all (37) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: No
View:

• 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.

Locations
United States
Arizona
Mayo Clinic Hospital
Scottsdale
California
Newport Beach Clinical Research Associates, Inc.
Newport Beach
Sutter Institute for Medical Research
Sacramento
Colorado
Alpine Clinical Research Center
Boulder
Mile High Research Center
Denver
Advanced Neurosciences Research, LLC
Fort Collins
Connecticut
Hartford Headache Center
East Hartford
Washington, D.c.
Medstar Clinical Research at Washington Hospital Center
Washington
Florida
Jacksonville Center for Clinical Research
Jacksonville
Neurology Associates
Maitland
Intercoastal Neurology
Sarasota
Axiom Clinical Research of Florida
Tampa
Georgia
Neurology Specialists of Decatur
Decatur
Illinois
Evanston Northwestern HealthCare
Evanston
Massachusetts
Stroke + NeuroCritical Care Stroke Service
Boston
New England Regional Headache Center
Worcester
Maryland
Mid-Atlantic Headache Institute
Pikesville
Michigan
Providence Hospital & Medical Centers, Inc.
Southfield
Missouri
Mercy Health Research-Neurology
Saint Louis
Radiant Research
Saint Louis
North Carolina
MedARK Clinical Research
Morganton
Clinical Research of Winston-Salem
Winston-salem
Guilford Neurologic Associates, Inc.
Winston-salem
Wake Forest Univ. Health Sciences - BMC
Winston-salem
New Jersey
Shore Neurology, PA
Toms River
New York
Upstate Clinical Research, LLC
Albany
Pennsylvania
Neurology and Sleep Medicine, P.C.
Bethlehem
Drexel University College of Medicine
Philadelphia
Clinical Trials Research Services, LLC
Pittsburgh
HAN Neurological Associates
Upland
Texas
Bellaire Neurology, PA
Bellaire
Texas Neurology, PA
Dallas
Houston Headache Clinic
Houston
Virginia
University of Virginia Neurology
Charlottesville
Commonwealth Clinical Research Specialists, Inc.
Richmond
Brighton Research Group, LLC
Virginia Beach
Washington
Swedish Pain & Headache Specialist
Seattle
Time Frame
Start Date: November 2005
Completion Date: March 2012
Participants
Target number of participants: 168
Treatments
Active Comparator: Test Arm with Premere investigational
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.
Authors
David Dodick, Robert Sommer
Sponsors
Leads: Abbott Medical Devices

This content was sourced from clinicaltrials.gov

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