Trial Information

Summary: Effect of Septal Closure of Atrial PFO on Events of Migraine with PREMERE: the ESCAPE migraine trial

Diagnosis: Migraine Headache and Patent Foramen Ovale (PFO)

The ESCAPE migraine trial is a clinical trial that will evaluate the benefits of PFO closure in patients with migraine headaches who also have a PFO. Patients who have a PFO and migraines, who qualify for the trial and who choose to participate will be randomly assigned to have their PFO closed using a device called the Premere™ PFO Closure system. All patients who enroll in the trial will be asked to keep a detailed electronic diary of their migraines for one year.

The goal is to determine whether or not using a device to close the PFO will actually improve migraine headaches enough to be a therapy option for patients with migraine. Patients will not know if they received the PFO closure device until they finish the one year trial. This will help the trial determine the effectiveness of PFO closure alone.

Eligibility Criteria:

You may be eligible for participation in a study if you:

• Have a PFO
• Have migraine headaches

Investigators:

Neurologist: Susan Rubin, MD
Cardiologist: Ted Feldman, MD

Sponsors: St.  Jude Medical

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Trial listings updated: June 1, 2008 at 6:32:50 AM