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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. Identifier: NCT00355056
Recruitment Status : Completed
First Posted : July 21, 2006
Last Update Posted : February 12, 2016
Information provided by (Responsible Party):
St. Jude Medical

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.

Condition or disease Intervention/treatment Phase
Migraine Headaches Patent Foramen Ovale Other: Sham Procedure Device: AMPLATZER PFO Occluder Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : January 2006
Actual Primary Completion Date : February 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Sham Comparator: 1 Other: Sham Procedure
Sham Procedure

Experimental: 2
PFO device Closure
Device: AMPLATZER PFO Occluder
Patients in this arm will receive the AMPLATZER PFO Occluder device

Primary Outcome Measures :
  1. Whether subjects with percutaneous PFO closure experience a reduction in migraine attacks. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00355056

  Hide Study Locations
United States, Arizona
St. Joseph's Hospital & Medical Center
Phoenix, Arizona, United States, 85013
United States, California
UCLA School of Medicine
Los Angeles, California, United States, 90095
United States, Colorado
Memorial Hospital
Colorado Springs, Colorado, United States, 80909
Swedish Medical Center
Englewood, Colorado, United States, 80113
Medical Center of the Rockies
Fort Collins, Colorado, United States, 80528
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52240
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70124
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Mayo Clinic
Rochester, Minnesota, United States, 55905
St. Cloud Hospital
St. Cloud, Minnesota, United States, 56303
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
St. Johns's Mercy Medical Center
St. Louis, Missouri, United States, 63141
United States, Nebraska
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
United States, Nevada
Children's Heart Center Las Vegas
Las Vegas, Nevada, United States, 89109
United States, New York
Mercy Hospital of Buffalo
Buffalo, New York, United States, 14214
University of Rochester Medical School
Rochester, New York, United States, 14642-8679
United States, Pennsylvania
Pinnacle Health Hospitals
Harrisburg, Pennsylvania, United States, 17104
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
United States, Utah
St. Mark's Hospital
Salt Lake City, Utah, United States, 84124
Intermountain Medical Center
Salt Lake City, Utah, United States, 84143
United States, Virginia
Inova Healthcare Services
Falls Church, Virginia, United States, 22042
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
United States, Wisconsin
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
St. Jude Medical
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: St. Jude Medical Identifier: NCT00355056     History of Changes
Other Study ID Numbers: AGA-010
First Posted: July 21, 2006    Key Record Dates
Last Update Posted: February 12, 2016
Last Verified: February 2016

Keywords provided by St. Jude Medical:
Migraine Headache
patent foramen ovale

Additional relevant MeSH terms:
Migraine Disorders
Foramen Ovale, Patent
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities