Clinical trial NCT00267371: ESCAPE Migraine Trial
Official title: Effect of Septal Closure of Atrial PFO on Events of Migraine With Premere: ESCAPE Migraine Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Migraine Disorders
Heart Septal Defects, Atrial
Keywords: Migraine headache
Patent Foramen Ovale
Patent Foramen Ovale Closure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2005-12-20
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Primary Endpoint 1: Effectiveness
timeFrame: 12 months
measure: The primary effectiveness measure is the decrease in the frequency of migraine headaches.
timeFrame: monthly
measure: The primary safety endpoint is the rate of major complications
timeFrame: monthly
Secondary outcomes:
measure: Secondary Endpoint 1: Effect of Aura
timeFrame: on-going
measure: Secondary Endpoint 2: Assessment of Procedural Success and Long-Term Device Performance
timeFrame: Five years
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: Newport Beach
country: United States
facility: Newport Beach Clinical Research Associates, Inc.
state: California
city: Sacramento
country: United States
facility: Sutter Institute for Medical Research
state: California
city: Boulder
country: United States
facility: Alpine Clinical Research Center
state: Colorado
city: Denver
country: United States
facility: Mile High Research Center
state: Colorado
city: Fort Collins
country: United States
facility: Advanced Neurosciences Research, LLC
state: Colorado
city: East Hartford
country: United States
facility: Hartford Headache Center
state: Connecticut
city: Washington
country: United States
facility: Medstar Clinical Research at Washington Hospital Center
state: District of Columbia
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Maitland
country: United States
facility: Neurology Associates
state: Florida
city: Sarasota
country: United States
facility: Intercoastal Neurology
state: Florida
city: Tampa
country: United States
facility: Axiom Clinical Research of Florida
state: Florida
city: Decatur
country: United States
facility: Neurology Specialists of Decatur
state: Georgia
city: Evanston
country: United States
facility: Evanston Northwestern HealthCare
state: Illinois
city: Pikesville
country: United States
facility: Mid-Atlantic Headache Institute
state: Maryland
city: Boston
country: United States
facility: Stroke + NeuroCritical Care Stroke Service
state: Massachusetts
city: Worcester
country: United States
facility: New England Regional Headache Center
state: Massachusetts
city: Southfield
country: United States
facility: Providence Hospital & Medical Centers, Inc.
state: Michigan
city: Saint Louis
country: United States
facility: Mercy Health Research-Neurology
state: Missouri
city: Saint Louis
country: United States
facility: Radiant Research
state: Missouri
city: Toms River
country: United States
facility: Shore Neurology, PA
state: New Jersey
city: Albany
country: United States
facility: Upstate Clinical Research, LLC
state: New York
city: Morganton
country: United States
facility: MedARK Clinical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Clinical Research of Winston-Salem
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Univ. Health Sciences - BMC
state: North Carolina
city: Winston-Salem
country: United States
facility: Guilford Neurologic Associates, Inc.
state: North Carolina
city: Bethlehem
country: United States
facility: Neurology and Sleep Medicine, P.C.
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Clinical Trials Research Services, LLC
state: Pennsylvania
city: Upland
country: United States
facility: HAN Neurological Associates
state: Pennsylvania
city: Bellaire
country: United States
facility: Bellaire Neurology, PA
state: Texas
city: Dallas
country: United States
facility: Texas Neurology, PA
state: Texas
city: Houston
country: United States
facility: Houston Headache Clinic
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Neurology
state: Virginia
city: Richmond
country: United States
facility: Commonwealth Clinical Research Specialists, Inc.
state: Virginia
city: Virginia Beach
country: United States
facility: Brighton Research Group, LLC
state: Virginia
city: Seattle
country: United States
facility: Swedish Pain & Headache Specialist
state: Washington
Study officials:
affiliation: Columbia University
name: Robert Sommer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: David Dodick, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.