Clinical Trial: ESCAPE Migraine Trial

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Summary:

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.


Sponsor: St. Jude Medical

Current Primary Outcome:

  • Primary Endpoint 1: Effectiveness [ Time Frame: 12 months ]
  • The primary effectiveness measure is the decrease in the frequency of migraine headaches. [ Time Frame: monthly ]
  • The primary safety endpoint is the rate of major complications [ Time Frame: monthly ]


Original Primary Outcome:

  • 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


Current Secondary Outcome:

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


Original Secondary Outcome:

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


Information By: St. Jude Medical

Dates:
Date Received: December 16, 2005
Date Started: November 2005
Date Completion:
Last Updated: August 23, 2016
Last Verified: August 2016