ESCAPE Migraine Trial

Launched by ABBOTT MEDICAL DEVICES · Dec 16, 2005

Keywords

ClinConnect Summary

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 evide...

Gender

ALL

Eligibility 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