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This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AGA Medical Corporation
ClinicalTrials.gov Identifier:
NCT00355056
First received: July 19, 2006
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Migraine Headaches
Patent Foramen Ovale
Other: Sham Procedure
Device: AMPLATZER PFO Occluder
Phase 2

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
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.

Resource links provided by NLM:


Further study details as provided by AGA Medical Corporation:

Primary Outcome Measures:
  • Whether subjects with percutaneous PFO closure experience a reduction in migraine attacks. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 230
Study Start Date: January 2006
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355056

  Hide Study Locations
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
Intermountain Medical Center
Salt Lake City, Utah, United States, 84143
St. Mark's Hospital
Salt Lake City, Utah, United States, 84124
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
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
AGA Medical Corporation
Investigators
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
  More Information

No publications provided

Responsible Party: AGA Medical Corporation
ClinicalTrials.gov Identifier: NCT00355056     History of Changes
Other Study ID Numbers: AGA-010, G050054
Study First Received: July 19, 2006
Last Updated: December 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AGA Medical Corporation:
Migraine
PFO
Migraine Headache
patent foramen ovale

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

ClinicalTrials.gov processed this record on July 23, 2014