Friday, March 03, 2006

First Patient Enrolled in St. Jude Medical's Migraine Headache Study; Clinical Trial

First Patient Enrolled in St. Jude Medical's Migraine Headache Study; Clinical Trial to Explore Link between Common Heart Defect and Migraine Headaches
St. Jude Medical, Inc. (NYSE:STJ) today announced the enrollment of the first patient in its ESCAPE (Effect of Septal Closure of Atrial PFO on Events of Migraine with Premere(TM)) migraine trial.

The first patient, a Virginia woman, will be one of over 500 patients to participate in the study, which received approval from the U.S. Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) in December 2005.

"Migraine is one of the 20 most disabling conditions that exists, according to the World Health Organization, and despite many good medications that help control the disease, millions of patients continue to suffer," said Dr. Neil Pugach, the first enrolling physician, a neurologist with the Brighton Research Group in Virginia Beach, Virginia. "Some patients struggle with the idea of having to take daily medications to treat their migraines, so it is exciting to think that an alternative treatment might prove successful."

"Patent foramen ovale (PFO) is a common heart defect without symptoms in most people," said Robert Sommer, M.D., Columbia Presbyterian Hospital, principal cardiology investigator for the trial. "However, PFOs have been linked to stroke and decompression illness (which may accompany activities like scuba diving), and it appears that PFOs may also play a prominent role in migraine headaches. The goal of this landmark trial is to determine if closing a PFO will help in reducing migraine attacks."

Migraine headaches are a neurological disorder characterized by chronic and disabling headaches. Approximately 10 percent of the population suffers from the disorder, and it has a prevalence rate estimated as high as 25 percent in young women.

"This trial will examine the benefit of treating a common heart defect - patent foramen ovale - in patients with migraine headaches," said David W. Dodick, M.D., Mayo Clinic College of Medicine, principal neurology investigator of the trial. "While the connection between a heart defect and head pain may seem counterintuitive, there is growing evidence that patients with migraines are more likely to have a PFO, and if repaired, it may lead to a reduction in migraine attacks. This is an exciting area of research into a chronic and disabling disease that affects millions of Americans, and I am enthusiastic about playing a role in this carefully controlled landmark U.S. study, which could answer these very important questions."

"Stroke prevention is an important aspect of PFO repair," said Dr. Sommer. "But migraine headaches are a part of daily life for nearly 30 million Americans. Current migraine therapies are difficult to take because of side effects, and the treatments are often ineffective. The catheter closure of a PFO is a simple 30-minute procedure that has been shown to eliminate migraine headaches in many stroke sufferers. If successful, this trial will have a major impact on the quality of life of millions of people."

The association between PFOs and migraine headaches was first observed by physicians who treated PFOs to remedy other medical conditions such as stroke; these physicians later noticed a reduced frequency in patients' migraine headaches. Additional informal studies have shown reduced pain - after PFO closure - for migraine patients. It is not clear why patients with a PFO would be more likely to have migraines, or why closing the PFO might decrease migraine attacks. Some physicians speculate that blood that crosses the PFO, without being filtered by the lungs, has substances that trigger migraines. More about this at .


Migraines and Diving

Patent Foramen Ovale There have been recent reports of an association between cerebral emboli, migraines with aura and right to left shunts (PFO). Philip Foster et al, ...

[PDF] Scubadoc's Ten Foot Stop Newsletter, Jan. 31, 2005 File Format: PDF/Adobe Acrobat - View as HTML
Migraine-PFO study. Migraine - New Study to Examine Possible Link With the Heart ... PFO Migraines ...

See also this 2005 report:
Migraine - New Study to Examine Possible Link With the Heart

LONDON, January 16 /PRNewswire/ -- Doctors have received approval to investigate the possible link between migraine headache and a common heart defect, called a patent foramen ovale (PFO)(1), which research indicates is prevalent in up to 25% of the general population or 15 million people in the UK. The prevalence of PFO in migraine with aura patients is 50%, or twice what would be expected in the general population.

PFO closure - currently used to treat certain types of stroke and decompression sickness - has been associated in some patients as a treatment, which eliminates or reduces the frequency and severity of migraine attacks. Now, the MIST ( (Migraine Intervention with STARFlex(R) Technology) trial(2) will seek to demonstrate the effectiveness of this simple, non-invasive PFO closure procedure in the treatment of certain patients who suffer from these severe migraine headaches.

People who experience migraine with aura(3) are invited to participate in the study. More information is available from the Migraine Action Association, telephone: 0870-050-5898 or with no obligation to sign up.