PRIMA PFO Migraine Trial

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
AGA Medical Corporation
ClinicalTrials.gov Identifier:
NCT00505570
First received: July 20, 2007
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale (PFO, a slit-like opening between the right and left upper chambers (atria) of the heart which normally closes at or soon after birth) who are randomized to either undergo closure of the patent foramen ovale or continue with standard medical management.


Condition Intervention Phase
Migraine
Migraine With Aura
Patent Foramen Ovale
PFO
Device: AMPLATZER® PFO Occluder Device
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Percutaneous Closure of Patent Foramen Ovale In Migraine With Aura - A Randomized Prospective Study (Prima Trial)

Resource links provided by NLM:


Further study details as provided by AGA Medical Corporation:

Primary Outcome Measures:
  • Migraine headache frequency [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Responder rate; Acute migraine medication use; Quality of life evaluations; Effects of Anti-thrombotic medications; Adverse events; PFO Closure [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 107
Study Start Date: May 2006
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Medical Management
Experimental: PFO Closure Device: AMPLATZER® PFO Occluder Device
PFO device closure

Detailed Description:

The purpose of this study is to evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale (PFO, a slit-like opening between the right and left upper chambers (atria) of the heart which normally closes at or soon after birth) who are randomized to either undergo closure of the patent foramen ovale or continue with standard medical management.

  Eligibility

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

Inclusion Criteria:

  • Subjects who are age 18 to 65
  • Subjects who have migraine headaches with aura diagnosed by a doctor
  • Subjects who have not responded to or cannot take common migraine preventive medications

Exclusion Criteria:

  • Subjects with a clinical history of stroke
  • Subjects who cannot take aspirin and clopidogrel (Plavix)
  • Subjects who are 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: NCT00505570

Locations
Canada, Alberta
University of Calgary- Foothills Hospital
Calgary, Alberta, Canada, T2N 2T9
Alberta Health Services and the University of Alberta
Edmonton, Alberta, Canada
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Ontario
University of Ottawa
Ottawa, Ontario, Canada, K1H 1A2
Davisville Medical Center
Toronto, Ontario, Canada, M4S 1Y2
Canada, Quebec
Institut de Cardiologie de Montreal
Montreal, Quebec, Canada, H1T 1C8
Centre Hospitalier Universitaire de Québec
Quebec City, Quebec, Canada, G1V 4G5
Germany
Unfallkrankenhaus Berlin
Berlin, Germany, 12683
Martin-Luther-University Halle-Wittenberg
Halle, Germany, 06120
Universitätsklinikum Hamburg
Hamburg, Germany, 20246
Neurologisch-verhaltensmedizinische Schmerzklinik Kiel
Kiel, Germany, 24149
Universitätsklinikum Münster
Münster, Germany, 48129
Switzerland
Swiss Cardiovascular Center Bern
Bern, Switzerland, 3010
Kopfwehzentrum Hirslanden Zürich
Zürich, Switzerland, 8088
United Kingdom
Royal Sussex County Hospital
Brighton, United Kingdom, BN2 5BE
St. Mary's Hospital Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1NY
South Manchester University Hospital
Manchester, United Kingdom, M23 9LT
Sponsors and Collaborators
AGA Medical Corporation
Investigators
Study Chair: Prima Trial Steering Committee
  More Information

No publications provided

Responsible Party: AGA Medical Corporation
ClinicalTrials.gov Identifier: NCT00505570     History of Changes
Other Study ID Numbers: AGA010E
Study First Received: July 20, 2007
Last Updated: August 22, 2013
Health Authority: Germany: German Institute of Medical Documentation and Information
Canada: Health Canada
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AGA Medical Corporation:
Migraine
Migraine with aura
Patent foramen ovale
PFO

Additional relevant MeSH terms:
Migraine Disorders
Migraine with Aura
Foramen Ovale, Patent
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 11, 2014