'Escape Migraine' Clinical Trial Explores Possible Link between Migrianes and Common Heart Defect

An estimated 30 million Americans -- about 10 percent of the population -- suffer from migraine headaches, a neurological disorder characterized by chronic and disabling headaches. Currently, there is no cure for migraines. The headaches are often prevented and treated through drug therapy. However, some migraine sufferers either do not respond to medications or experience unpleasant side effects. Clinical Trial are now been conduct for possible link between migraines and PFO.

Minneapolis, MN (PRWEB) July 16, 2006 -- An estimated 30 million Americans -- about 10 percent of the population -- suffer from migraine headaches, a neurological disorder characterized by chronic and disabling headaches. Currently, there is no cure for migraines. The headaches are often prevented and treated through drug therapy. However, some migraine sufferers either do not respond to medications or experience unpleasant side effects. Clinical Trial are now been conduct for possible link between migraines and PFO.

In a clinical trial that aims to enroll roughly 500 people who suffer migraine headaches, researchers are studying a possible connection between migraines and a tiny hole within the heart, called a patent foramen ovale or PFO. The Escape Migraine clinical trial will test whether or not closing the PFO can reduce or eliminate migraine episodes.

Physicians first observed an association between PFOs and migraines when they closed the small opening in the heart in order to treat medical conditions such as stroke -- and later noticed a reduced frequency in their patients’ migraine headaches. Subsequent informal studies have suggested reduced migraine attacks after PFO closure.

A PFO occurs when a small hole between the upper right and upper left chambers of the heart fails to close during infancy. About 25 percent of adults have a PFO, and recent results have shown that, among migraine sufferers, up to 40 percent have the heart defect.

It is not clear why patients with migraine would be more likely to have a PFO, or why closing the PFO might decrease migraine attacks. Some physicians speculate that blood that crosses the PFO from the heart’s upper right to the upper left chamber, without first being filtered by the lungs, contains substances that trigger migraines.

The first participant in the ESCAPE Migraine trial was implanted with the Premere™ PFO Closure System made by St. Jude Medical, Inc., at Duke University Medical Center, Durham, North Carolina, in April 2006.    

“The goal of the trial is to determine if closing a PFO will significantly reduce migraine attacks, which routinely debilitate people and prevent them from working, socializing and enjoying a reasonable quality of life," said David W. Dodick, M.D., Mayo Clinic College of Medicine, Scottsdale, Arizona, the trial’s principal neurology investigator.

Investigators at 45 leading headache clinics and 15 leading interventional cardiology clinics across the United States plan to enroll patients who have not found migraine relief with preventive medications, have experienced unwanted side effects from drug therapy or have been advised by a doctor against taking the medications due to another condition.

After a test to determine if they have a PFO, participants in the clinical trial will be randomized and will have their PFO closed or remain on medication alone. A transcatheter approach is used to guide a small closure device to the heart from a vein in the leg. This approach is less invasive than open-heart surgery. Once the device is in the heart, the physician positions its two sides to cover and close the PFO.    

Sponsored by St. Jude Medical, the ESCAPE Migraine trial will use the company’s Premere™ PFO Closure System for closing PFOs. The Premere System is available only for investigational use in the United States.

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