PRIMA PFO Migraine Trial (PRIMA)

February 1, 2019 updated by: Abbott Medical Devices

Percutaneous Closure of Patent Foramen Ovale In Migraine With Aura - A Randomized Prospective Study (Prima Trial)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Medical Management
Experimental: PFO Closure
Device: AMPLATZER® PFO Occluder Device
PFO device closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Migraine headache frequency
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Responder rate; Acute migraine medication use; Quality of life evaluations; Effects of Anti-thrombotic medications; Adverse events; PFO Closure
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Study Chair: Prima Trial Steering Committee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

July 20, 2007

First Submitted That Met QC Criteria

July 20, 2007

First Posted (Estimate)

July 23, 2007

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGA010E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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