Status:
TERMINATED
ESCAPE Migraine Trial
Lead Sponsor:
Abbott Medical Devices
Conditions:
Migraine Disorders
Heart Septal Defects, Atrial
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 he...
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 c...
Eligibility Criteria
Inclusion
- Major
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT00267371
Start Date
November 1 2005
End Date
March 1 2012
Last Update
February 4 2019
Active Locations (37)
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1
Mayo Clinic Hospital
Scottsdale, Arizona, United States, 85054
2
Newport Beach Clinical Research Associates, Inc.
Newport Beach, California, United States, 92660
3
Sutter Institute for Medical Research
Sacramento, California, United States, 95816
4
Alpine Clinical Research Center
Boulder, Colorado, United States, 80304