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ESCAPE Migraine Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00267371
Recruitment Status : Terminated (Insufficient enrollment)
First Posted : December 20, 2005
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE December 16, 2005
First Posted Date  ICMJE December 20, 2005
Last Update Posted Date February 4, 2019
Study Start Date  ICMJE November 2005
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE ESCAPE Migraine Trial
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Migraine Disorders
  • Heart Septal Defects, Atrial
Intervention  ICMJE
  • 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  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 19, 2014)
168
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00267371
Other Study ID Numbers  ICMJE 1202-001
IDE G050112
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Abbott Medical Devices
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Abbott Medical Devices
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert Sommer, MD Columbia University
Principal Investigator: David Dodick, MD Mayo Clinic
PRS Account Abbott Medical Devices
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP