ESCAPE Migraine Trial

Sponsor

Abbott Medical Devices (Industry)

Overall Status

Terminated

CT.gov ID

NCT00267371

Collaborator

(none)

168

Enrollment

Locations

Arms

Duration (Months)

4.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Migraine Disorders Heart Septal Defects, Atrial	Device: PFO Closure with Premere investigational device. Drug: Medical management/current medications per standard of care by personal physician.	Phase 3

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 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

168 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2005

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Test Arm with Premere investigational PFO Closure with Premere investigational device.	Device: PFO Closure with Premere investigational device. 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.	Drug: Medical management/current medications per standard of care by personal physician. Medical management with current medications per standard of care by personal physician. Other Names: Currently prescribed medications.

Arm

Intervention/Treatment

Active Comparator: Test Arm with Premere investigational

PFO Closure with Premere investigational device.

Device: PFO Closure with Premere investigational device.

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.

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

Medical management with current medications per standard of care by personal physician.

Other Names:

Currently prescribed medications.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Secondary Endpoint 1: Effect of Aura [on-going]
Secondary Endpoint 2: Assessment of Procedural Success and Long-Term Device Performance [Five years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Mile High Research Center	Denver	Colorado	United States	80218
6	Advanced Neurosciences Research, LLC	Fort Collins	Colorado	United States	80528
7	Hartford Headache Center	East Hartford	Connecticut	United States	06118
8	Medstar Clinical Research at Washington Hospital Center	Washington	District of Columbia	United States	20010
9	Jacksonville Center for Clinical Research	Jacksonville	Florida	United States	32216
10	Neurology Associates	Maitland	Florida	United States	32751
11	Intercoastal Neurology	Sarasota	Florida	United States	34232
12	Axiom Clinical Research of Florida	Tampa	Florida	United States	33609
13	Neurology Specialists of Decatur	Decatur	Georgia	United States	30033
14	Evanston Northwestern HealthCare	Evanston	Illinois	United States	60201
15	Mid-Atlantic Headache Institute	Pikesville	Maryland	United States	21208
16	Stroke + NeuroCritical Care Stroke Service	Boston	Massachusetts	United States	02114
17	New England Regional Headache Center	Worcester	Massachusetts	United States	01605
18	Providence Hospital & Medical Centers, Inc.	Southfield	Michigan	United States	48075
19	Mercy Health Research-Neurology	Saint Louis	Missouri	United States	63141
20	Radiant Research	Saint Louis	Missouri	United States	63141
21	Shore Neurology, PA	Toms River	New Jersey	United States	08755
22	Upstate Clinical Research, LLC	Albany	New York	United States	12205
23	MedARK Clinical Research	Morganton	North Carolina	United States	28655
24	Clinical Research of Winston-Salem	Winston-Salem	North Carolina	United States	27103
25	Wake Forest Univ. Health Sciences - BMC	Winston-Salem	North Carolina	United States	27157
26	Guilford Neurologic Associates, Inc.	Winston-Salem	North Carolina	United States	27401
27	Neurology and Sleep Medicine, P.C.	Bethlehem	Pennsylvania	United States	18015
28	Drexel University College of Medicine	Philadelphia	Pennsylvania	United States	19102
29	Clinical Trials Research Services, LLC	Pittsburgh	Pennsylvania	United States	15206
30	HAN Neurological Associates	Upland	Pennsylvania	United States	19013
31	Bellaire Neurology, PA	Bellaire	Texas	United States	77401
32	Texas Neurology, PA	Dallas	Texas	United States	75214
33	Houston Headache Clinic	Houston	Texas	United States	77004
34	University of Virginia Neurology	Charlottesville	Virginia	United States	22903
35	Commonwealth Clinical Research Specialists, Inc.	Richmond	Virginia	United States	23233
36	Brighton Research Group, LLC	Virginia Beach	Virginia	United States	23452
37	Swedish Pain & Headache Specialist	Seattle	Washington	United States	98104