NCT00267371

ESCAPE Migraine Trial

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Migraine Disorders
• Heart Septal Defects, Atrial

Interventions

Type	Name	Description
DEVICE	PFO Closure with Premere investigational device.	PFO Closure with Premere investigational device.
DRUG	Medical management/current medications per standard of care by personal physician.	Medical management with current medications per standard of care by personal physician.

Timeline

• Start date: 2005-11-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2005-12-20
• Last updated: 2019-02-04

Locations

37 sites across 1 country: United States