ESCAPE Migraine Trial

• Status: Terminated
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott Medical Devices; St. Jude Medical

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