Clinical Trial: ESCAPE Migraine Trial

This study is not yet open for patient recruitment.
Verified by St. Jude Medical December 2005

Sponsored by: St. Jude Medical
Information provided by: St. Jude Medical Identifier: NCT00267371


The purpose of this 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
Phase II

MedlinePlus related topics:  Congenital Heart Disease;   Migraine

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by St. Jude Medical:
Primary Outcomes: Primary Endpoint 1: Effectiveness; The primary effectiveness measure is the decrease in the frequency of migraine headaches.; Primary Endpoint 2: Safety; The primary safety endpoint is the rate of major complications
Secondary Outcomes: Secondary Endpoint 1: Effect of Aura; Secondary Endpoint 2: Assessment of Procedural Success and Long-Term Device Performance

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   -   55 Years,  Genders Eligible for Study:  Both

Inclusion Criteria:

  • Patient must be between the ages of 18 and 55;
  • 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.

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
Please refer to this study by identifier  NCT00267371

More Information

Study ID Numbers:  1202-001
Last Updated:  December 19, 2005
Record first received:  December 16, 2005 Identifier:  NCT00267371
Health Authority: United States: Food and Drug Administration processed this record on 2006-01-10


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