ESCAPE Migraine Trial

This study has been terminated.
(Insufficient enrollment)
Information provided by:
St. Jude Medical Identifier:
First received: December 16, 2005
Last updated: September 22, 2011
Last verified: September 2011

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 Intervention Phase
Migraine Disorders
Heart Septal Defects, Atrial
Device: PFO Closure
Device: Sham procedure.
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Septal Closure of Atrial PFO on Events of Migraine With Premere: ESCAPE Migraine Trial

Resource links provided by NLM:

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Primary Endpoint 1: Effectiveness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The primary effectiveness measure is the decrease in the frequency of migraine headaches. [ Time Frame: monthly ] [ Designated as safety issue: No ]
  • The primary safety endpoint is the rate of major complications [ Time Frame: monthly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary Endpoint 1: Effect of Aura [ Time Frame: on-going ] [ Designated as safety issue: No ]
  • Secondary Endpoint 2: Assessment of Procedural Success and Long-Term Device Performance [ Time Frame: Five years ] [ Designated as safety issue: No ]

Estimated Enrollment: 492
Study Start Date: November 2005
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Test Arm
PFO Closure with investigational device.
Device: PFO Closure
Trans-catheter closure of PFO with the Premere Device
Sham Comparator: Control Arm
Patients in the control group arm will not receive the medical device and will continue medical management.
Device: Sham procedure.
Right heart catheritization procedure, PFO assessment and randomization are blinded. Control arm patients continue use of preventive medications.

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.


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Please refer to this study by its identifier: NCT00267371

  Show 37 Study Locations
Sponsors and Collaborators
St. Jude Medical
Principal Investigator: Robert Sommer, MD Columbia University
Principal Investigator: David Dodick, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: St. Jude Medical Cardiovascular Division, St. Jude Medical Identifier: NCT00267371     History of Changes
Other Study ID Numbers: 1202-001, IDE G050112
Study First Received: December 16, 2005
Last Updated: September 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Jude Medical:
Migraine headache
Patent Foramen Ovale
Patent Foramen Ovale Closure

Additional relevant MeSH terms:
Heart Septal Defects
Heart Septal Defects, Atrial
Migraine Disorders
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on April 17, 2014