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ESCAPE Migraine Trial
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Migraine Disorders Heart Septal Defects, Atrial | Device: PFO Closure with Premere investigational device. Drug: Medical management/current medications per standard of care by personal physician. | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Septal Closure of Atrial PFO on Events of Migraine With Premere: ESCAPE Migraine Trial |
- Primary Endpoint 1: Effectiveness [ Time Frame: 12 months ]
- The primary effectiveness measure is the decrease in the frequency of migraine headaches. [ Time Frame: monthly ]
- The primary safety endpoint is the rate of major complications [ Time Frame: monthly ]
- Secondary Endpoint 1: Effect of Aura [ Time Frame: on-going ]
- Secondary Endpoint 2: Assessment of Procedural Success and Long-Term Device Performance [ Time Frame: Five years ]
| Enrollment: | 168 |
| Study Start Date: | November 2005 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Test Arm with Premere investigational
PFO Closure with Premere investigational device.
|
Device: PFO Closure with Premere investigational device.
PFO Closure with Premere investigational device.
|
|
Active Comparator: Medical management/current medications
Patients in the control group arm will not receive the medical device and will continue medical management.
|
Drug: Medical management/current medications per standard of care by personal physician.
Medical management with current medications per standard of care by personal physician.
Other Name: Currently prescribed medications.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00267371
Show 37 Study Locations
| Principal Investigator: | Robert Sommer, MD | Columbia University |
| Principal Investigator: | David Dodick, MD | Mayo Clinic |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | St. Jude Medical |
| ClinicalTrials.gov Identifier: | NCT00267371 History of Changes |
| Other Study ID Numbers: |
1202-001 IDE G050112 |
| Study First Received: | December 16, 2005 |
| Last Updated: | August 23, 2016 |
Keywords provided by St. Jude Medical:
|
Migraine headache Patent Foramen Ovale Patent Foramen Ovale Closure |
Additional relevant MeSH terms:
|
Migraine Disorders Heart Septal Defects Heart Septal Defects, Atrial Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Congenital Abnormalities |
ClinicalTrials.gov processed this record on July 18, 2017