ESCAPE Migraine Trial - Full Text View

Sponsored by:	St. Jude Medical
Information provided by:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00267371

Purpose

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.

Condition	Intervention	Phase
Migraine Disorders Heart Septal Defects, Atrial	Device: PFO Closure Device: Sham procedure.	Phase III

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of Septal Closure of Atrial PFO on Events of Migraine With Premere: ESCAPE Migraine Trial

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:

Primary Endpoint 1: Effectiveness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The primary effectiveness measure is the decrease in the frequency of migraine headaches. [ Time Frame: monthly ] [ Designated as safety issue: No ]
The primary safety endpoint is the rate of major complications [ Time Frame: monthly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Secondary Endpoint 1: Effect of Aura [ Time Frame: on-going ] [ Designated as safety issue: No ]
Secondary Endpoint 2: Assessment of Procedural Success and Long-Term Device Performance [ Time Frame: Five years ] [ Designated as safety issue: No ]

Estimated Enrollment:	492
Study Start Date:	November 2005
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Test Arm: Active Comparator PFO Closure with investigational device.	Device: PFO Closure Trans-catheter closure of PFO with the Premere Device
Control Arm: Sham Comparator Patients in the control group arm will not receive the medical device and will continue medical management.	Device: Sham procedure. Right heart catheritization procedure, PFO assessment and randomization are blinded. Control arm patients continue use of preventive 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
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267371

Show 37 Study Locations

Sponsors and Collaborators

St. Jude Medical

Investigators

Principal Investigator:	Robert Sommer, MD	Columbia University Medical Center
Principal Investigator:	David Dodick, MD	Mayo Clinic Scottsdale

More Information

ESCAPE Migraine Clinical Trial Website This link exits the ClinicalTrials.gov site

Responsible Party:	St. Jude Medical ( St. Jude Medical Cardiovascular Division )
Study ID Numbers:	1202-001, IDE G050112
Study First Received:	December 16, 2005
Last Updated:	September 18, 2008
ClinicalTrials.gov Identifier:	NCT00267371
Health Authority:	United States: Food and Drug Administration

Keywords provided by St. Jude Medical:

Migraine headache
Patent Foramen Ovale
Patent Foramen Ovale Closure

Study placed in the following topic categories:

Heart Septal Defects
Heart Diseases
Cardiovascular Abnormalities
Central Nervous System Diseases
Headache Disorders, Primary
Brain Diseases
Heart Septal Defects, Atrial

Headache Disorders
Congenital heart septum defect
Migraine Disorders
Foramen Ovale, Patent
Headache
Congenital Abnormalities
Heart Defects, Congenital

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009