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Premium 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: NCT00355056
Recruitment Status : Completed
First Posted : July 21, 2006
Last Update Posted : February 12, 2016
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE July 19, 2006
First Posted Date  ICMJE July 21, 2006
Last Update Posted Date February 12, 2016
Study Start Date  ICMJE January 2006
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2010)
Whether subjects with percutaneous PFO closure experience a reduction in migraine attacks. [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 19, 2006)
Whether subjects with percutaneous PFO closure experience a reduction in migraine attacks.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2010)
Change in the average number of migraine days; change in MIDAS score; reduction in the number of acute and/or rescue migraine medications; complete closure of the defect; improvement of Quality of Life; Improvement in the BECK Depression Inventory [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2006)
Change in the average number of migraine days; change in MIDAS score; reduction in the number of acute and/or rescue migraine medications; complete closure of the defect; improvement of Quality of Life; Improvement in the BECK Depression Inventory
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Premium Migraine Trial
Official Title  ICMJE Prospective, Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management.
Brief Summary The Purpose of this study is to evaluate the impact of percutaneous closure of a patent foramen ovale (a hole in the heart), using the AMPLATZER PFO Occluder, on the incidence of migraine headaches.
Detailed Description The objective of this study is to evaluate whether percutaneous PFO closure is effective in reducing the incidence of disabling migraine headaches in patients who are refactory to medical treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Migraine Headaches
  • Patent Foramen Ovale
Intervention  ICMJE
  • Other: Sham Procedure
    Sham Procedure
  • Device: AMPLATZER PFO Occluder
    Patients in this arm will receive the AMPLATZER PFO Occluder device
Study Arms  ICMJE
  • Sham Comparator: 1
    Intervention: Other: Sham Procedure
  • Experimental: 2
    PFO device Closure
    Intervention: Device: AMPLATZER PFO Occluder
Publications * Tobis JM, Charles A, Silberstein SD, Sorensen S, Maini B, Horwitz PA, Gurley JC. Percutaneous Closure of Patent Foramen Ovale in Patients With Migraine: The PREMIUM Trial. J Am Coll Cardiol. 2017 Dec 5;70(22):2766-2774. doi: 10.1016/j.jacc.2017.09.1105.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2010)
230
Original Enrollment  ICMJE
 (submitted: July 19, 2006)
466
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects diagnosed as having migraine headaches both with and without aura
  • Have a Patent Foramen Ovale (PFO)
  • A migraine history and show a refractoriness to medical treatment
  • Willing to participate in follow-up visits

Exclusion Criteria:

  • Subjects whose primary headaches are other than migraine headaches
  • Who overuse migraine treatments
  • With a clinical history of stroke or Transient Ischemic Attack (TIA)
  • With contraindication to aspirin therapy and Clopidogrel
  • Pregnant or desire to become pregnant within the next year
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 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 NCT00355056
Other Study ID Numbers  ICMJE AGA-010
G050054
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abbott Medical Devices
Study Sponsor  ICMJE Abbott Medical Devices
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sherman Sorensen, M.D. Intermountain Medical Center
Principal Investigator: Stephen Silberstein, M.D. Thomas Jefferson University
Principal Investigator: Jonathan Tobis, M.D. University of California, Los Angeles
Principal Investigator: Andrew Charles, MD University of California, Los Angeles
PRS Account Abbott Medical Devices
Verification Date February 2016

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