ESCAPE Migraine Trial

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

Tracking Information

• First Submitted Date: December 16, 2005
• First Posted Date: December 20, 2005
• Last Update Posted Date: February 4, 2019
• Study Start Date: November 2005
• Actual Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 14, 2008)

• 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 ]

Original Primary Outcome Measures (submitted: December 16, 2005)

• Primary Endpoint 1: Effectiveness
• The primary effectiveness measure is the decrease in the frequency of migraine headaches.
• Primary Endpoint 2: Safety
• The primary safety endpoint is the rate of major complications

Current Secondary Outcome Measures (submitted: March 14, 2008)

• 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 ]

Original Secondary Outcome Measures (submitted: December 16, 2005)

• Secondary Endpoint 1: Effect of Aura
• Secondary Endpoint 2: Assessment of Procedural Success and Long-Term Device Performance

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: ESCAPE Migraine Trial
• Official Title: Effect of Septal Closure of Atrial PFO on Events of Migraine With Premere: ESCAPE Migraine Trial
• 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.

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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Migraine Disorders
• Heart Septal Defects, Atrial

Intervention

• Device: PFO Closure with Premere investigational device.
  PFO Closure with Premere investigational device.
• 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.

Study Arms

• Active Comparator: Test Arm with Premere investigational
  PFO Closure with Premere investigational device.
  Intervention: 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.
  Intervention: Drug: Medical management/current medications per standard of care by personal physician.

• Publications *: Sharan A, Huh B, Narouze S, Trentman T, Mogilner A, Vaisman J, Ordia J, Deer T, Venkatesan L, Slavin K. Analysis of adverse events in the management of chronic migraine by peripheral nerve stimulation. Neuromodulation. 2015 Jun;18(4):305-12; discussion 312. doi: 10.1111/ner.12243. Epub 2014 Oct 14.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: May 19, 2014): 168
• Original Enrollment: Not Provided
• Actual Study Completion Date: March 2012
• Actual Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00267371
• Other Study ID Numbers: 1202-001; IDE G050112
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Abbott Medical Devices
• Original Responsible Party: Not Provided
• Current Study Sponsor: Abbott Medical Devices
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Robert Sommer, MD; Columbia University
• Principal Investigator: David Dodick, MD; Mayo Clinic

• PRS Account: Abbott Medical Devices
• Verification Date: January 2019