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Brief Summary

Official Title: “Prospective, Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management.”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: February 2015

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

  • Other: Sham Procedure
    • Sham Procedure
  • Device: AMPLATZER PFO Occluder
    • Patients in this arm will receive the AMPLATZER PFO Occluder device

Arms, Groups and Cohorts in this Clinical Trial

  • Sham Comparator: 1
  • Experimental: 2
    • PFO device Closure

Outcome Measures for this Clinical Trial

Primary Measures

  • Whether subjects with percutaneous PFO closure experience a reduction in migraine attacks.
    • Time Frame: 12 months
      Safety Issue?: No

Secondary Measures

  • 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
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • St. Jude Medical
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sherman Sorensen, M.D., Principal Investigator, Intermountain Medical Center
    • Stephen Silberstein, M.D., Principal Investigator, Thomas Jefferson University
    • Jonathan Tobis, M.D., Principal Investigator, University of California, Los Angeles
    • Andrew Charles, MD, Principal Investigator, University of California, Los Angeles


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