ESCAPE Migraine Trial

Abbott

Status and phase

Terminated

Phase 3

Conditions

Migraine Disorders

Heart Septal Defects, Atrial

Treatments

Device: PFO Closure with Premere investigational device.

Drug: Medical management/current medications per standard of care by personal physician.

Study type

Interventional

Funder types

Industry

Identifiers

NCT00267371

1202-001

IDE G050112

Details and patient eligibility

About

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.

Full description

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.

Enrollment

168 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Major Inclusion Criteria:

Patient must be between the ages of 18 and 70;
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.

Major 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