ESCAPE Migraine Trial

Migraine Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00267371
• Other study ID #: 1202-001
• Secondary ID: IDE G050112
• Status: Terminated
• Phase: Phase 3
• Start date: November 2005
• Est. completion date: March 2012

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 168
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Septal Defects
• Heart Septal Defects, Atrial
• Migraine Disorders

Intervention

Device:
• PFO Closure with Premere investigational device.
PFO Closure with Premere investigational device.

Drug:
• Medical management/current medications per standard of care by personal physician.
Medical management with current medications per standard of care by personal physician.

Locations

Country	Name	City	State
United States	Upstate Clinical Research, LLC	Albany	New York
United States	Bellaire Neurology, PA	Bellaire	Texas
United States	Neurology and Sleep Medicine, P.C.	Bethlehem	Pennsylvania
United States	Stroke + NeuroCritical Care Stroke Service	Boston	Massachusetts
United States	Alpine Clinical Research Center	Boulder	Colorado
United States	University of Virginia Neurology	Charlottesville	Virginia
United States	Texas Neurology, PA	Dallas	Texas
United States	Neurology Specialists of Decatur	Decatur	Georgia
United States	Mile High Research Center	Denver	Colorado
United States	Hartford Headache Center	East Hartford	Connecticut
United States	Evanston Northwestern HealthCare	Evanston	Illinois
United States	Advanced Neurosciences Research, LLC	Fort Collins	Colorado
United States	Houston Headache Clinic	Houston	Texas
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Neurology Associates	Maitland	Florida
United States	MedARK Clinical Research	Morganton	North Carolina
United States	Newport Beach Clinical Research Associates, Inc.	Newport Beach	California
United States	Drexel University College of Medicine	Philadelphia	Pennsylvania
United States	Mid-Atlantic Headache Institute	Pikesville	Maryland
United States	Clinical Trials Research Services, LLC	Pittsburgh	Pennsylvania
United States	Commonwealth Clinical Research Specialists, Inc.	Richmond	Virginia
United States	Sutter Institute for Medical Research	Sacramento	California
United States	Mercy Health Research-Neurology	Saint Louis	Missouri
United States	Radiant Research	Saint Louis	Missouri
United States	Intercoastal Neurology	Sarasota	Florida
United States	Mayo Clinic Hospital	Scottsdale	Arizona
United States	Swedish Pain & Headache Specialist	Seattle	Washington
United States	Providence Hospital & Medical Centers, Inc.	Southfield	Michigan
United States	Axiom Clinical Research of Florida	Tampa	Florida
United States	Shore Neurology, PA	Toms River	New Jersey
United States	HAN Neurological Associates	Upland	Pennsylvania
United States	Brighton Research Group, LLC	Virginia Beach	Virginia
United States	Medstar Clinical Research at Washington Hospital Center	Washington	District of Columbia
United States	Clinical Research of Winston-Salem	Winston-Salem	North Carolina
United States	Guilford Neurologic Associates, Inc.	Winston-Salem	North Carolina
United States	Wake Forest Univ. Health Sciences - BMC	Winston-Salem	North Carolina
United States	New England Regional Headache Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Endpoint 1: Effectiveness		12 months
Primary	The primary effectiveness measure is the decrease in the frequency of migraine headaches.		monthly
Primary	The primary safety endpoint is the rate of major complications		monthly
Secondary	Secondary Endpoint 1: Effect of Aura		on-going
Secondary	Secondary Endpoint 2: Assessment of Procedural Success and Long-Term Device Performance		Five years