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ESCAPE Migraine Trial

Primary Purpose

Migraine Disorders, Heart Septal Defects, Atrial

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
PFO Closure with Premere investigational device.
Medical management/current medications per standard of care by personal physician.
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Disorders focused on measuring Migraine headache, Patent Foramen Ovale, Patent Foramen Ovale Closure

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mayo Clinic Hospital
  • Newport Beach Clinical Research Associates, Inc.
  • Sutter Institute for Medical Research
  • Alpine Clinical Research Center
  • Mile High Research Center
  • Advanced Neurosciences Research, LLC
  • Hartford Headache Center
  • Medstar Clinical Research at Washington Hospital Center
  • Jacksonville Center for Clinical Research
  • Neurology Associates
  • Intercoastal Neurology
  • Axiom Clinical Research of Florida
  • Neurology Specialists of Decatur
  • Evanston Northwestern HealthCare
  • Mid-Atlantic Headache Institute
  • Stroke + NeuroCritical Care Stroke Service
  • New England Regional Headache Center
  • Providence Hospital & Medical Centers, Inc.
  • Mercy Health Research-Neurology
  • Radiant Research
  • Shore Neurology, PA
  • Upstate Clinical Research, LLC
  • MedARK Clinical Research
  • Clinical Research of Winston-Salem
  • Wake Forest Univ. Health Sciences - BMC
  • Guilford Neurologic Associates, Inc.
  • Neurology and Sleep Medicine, P.C.
  • Drexel University College of Medicine
  • Clinical Trials Research Services, LLC
  • HAN Neurological Associates
  • Bellaire Neurology, PA
  • Texas Neurology, PA
  • Houston Headache Clinic
  • University of Virginia Neurology
  • Commonwealth Clinical Research Specialists, Inc.
  • Brighton Research Group, LLC
  • Swedish Pain & Headache Specialist

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Test Arm with Premere investigational

Medical management/current medications

Arm Description

PFO Closure with Premere investigational device.

Patients in the control group arm will not receive the medical device and will continue medical management.

Outcomes

Primary Outcome Measures

Primary Endpoint 1: Effectiveness
The primary effectiveness measure is the decrease in the frequency of migraine headaches.
The primary safety endpoint is the rate of major complications

Secondary Outcome Measures

Secondary Endpoint 1: Effect of Aura
Secondary Endpoint 2: Assessment of Procedural Success and Long-Term Device Performance

Full Information

First Posted
December 16, 2005
Last Updated
January 31, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00267371
Brief Title
ESCAPE Migraine Trial
Official Title
Effect of Septal Closure of Atrial PFO on Events of Migraine With Premere: ESCAPE Migraine Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Insufficient enrollment
Study Start Date
November 2005 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders, Heart Septal Defects, Atrial
Keywords
Migraine headache, Patent Foramen Ovale, Patent Foramen Ovale Closure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test Arm with Premere investigational
Arm Type
Active Comparator
Arm Description
PFO Closure with Premere investigational device.
Arm Title
Medical management/current medications
Arm Type
Active Comparator
Arm Description
Patients in the control group arm will not receive the medical device and will continue medical management.
Intervention Type
Device
Intervention Name(s)
PFO Closure with Premere investigational device.
Intervention Description
PFO Closure with Premere investigational device.
Intervention Type
Drug
Intervention Name(s)
Medical management/current medications per standard of care by personal physician.
Other Intervention Name(s)
Currently prescribed medications.
Intervention Description
Medical management with current medications per standard of care by personal physician.
Primary Outcome Measure Information:
Title
Primary Endpoint 1: Effectiveness
Time Frame
12 months
Title
The primary effectiveness measure is the decrease in the frequency of migraine headaches.
Time Frame
monthly
Title
The primary safety endpoint is the rate of major complications
Time Frame
monthly
Secondary Outcome Measure Information:
Title
Secondary Endpoint 1: Effect of Aura
Time Frame
on-going
Title
Secondary Endpoint 2: Assessment of Procedural Success and Long-Term Device Performance
Time Frame
Five years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Sommer, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Dodick, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Hospital
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Newport Beach Clinical Research Associates, Inc.
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Sutter Institute for Medical Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Alpine Clinical Research Center
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Mile High Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Advanced Neurosciences Research, LLC
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Hartford Headache Center
City
East Hartford
State/Province
Connecticut
ZIP/Postal Code
06118
Country
United States
Facility Name
Medstar Clinical Research at Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Neurology Associates
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Intercoastal Neurology
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Axiom Clinical Research of Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Neurology Specialists of Decatur
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Evanston Northwestern HealthCare
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Mid-Atlantic Headache Institute
City
Pikesville
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Stroke + NeuroCritical Care Stroke Service
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
New England Regional Headache Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Providence Hospital & Medical Centers, Inc.
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Mercy Health Research-Neurology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Radiant Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Shore Neurology, PA
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Upstate Clinical Research, LLC
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
MedARK Clinical Research
City
Morganton
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
Facility Name
Clinical Research of Winston-Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Wake Forest Univ. Health Sciences - BMC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Guilford Neurologic Associates, Inc.
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Neurology and Sleep Medicine, P.C.
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Clinical Trials Research Services, LLC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
HAN Neurological Associates
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
Bellaire Neurology, PA
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Texas Neurology, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75214
Country
United States
Facility Name
Houston Headache Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
University of Virginia Neurology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Commonwealth Clinical Research Specialists, Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
Facility Name
Brighton Research Group, LLC
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23452
Country
United States
Facility Name
Swedish Pain & Headache Specialist
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25313847
Citation
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.
Results Reference
derived

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ESCAPE Migraine Trial

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