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ESCAPE Migraine Trial

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ClinicalTrials.gov Identifier: NCT00267371
Recruitment Status : Terminated (Insufficient enrollment)
First Posted : December 20, 2005
Last Update Posted : February 4, 2019
Information provided by (Responsible Party):
Abbott Medical Devices

Brief 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.

Condition or disease Intervention/treatment 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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : November 2005
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Medicines Migraine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Primary Endpoint 1: Effectiveness [ Time Frame: 12 months ]
  2. The primary effectiveness measure is the decrease in the frequency of migraine headaches. [ Time Frame: monthly ]
  3. The primary safety endpoint is the rate of major complications [ Time Frame: monthly ]

Secondary Outcome Measures :
  1. Secondary Endpoint 1: Effect of Aura [ Time Frame: on-going ]
  2. Secondary Endpoint 2: Assessment of Procedural Success and Long-Term Device Performance [ Time Frame: Five years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00267371

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Sponsors and Collaborators
Abbott Medical Devices
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Principal Investigator: Robert Sommer, MD Columbia University
Principal Investigator: David Dodick, MD Mayo Clinic
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT00267371    
Other Study ID Numbers: 1202-001
IDE G050112
First Posted: December 20, 2005    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Keywords provided by Abbott Medical Devices:
Migraine headache
Patent Foramen Ovale
Patent Foramen Ovale Closure
Additional relevant MeSH terms:
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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