PRIMA PFO Migraine Trial

Phase 2

Terminated

• Conditions: Patent Foramen Ovale; PFO; Migraine With Aura; Migraine

• Registration Number: NCT00505570
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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.

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 Timeline

• Study Start: 2006-05
• Study First Submitted: 2007-07-20
• Study First Submitted QC: 2007-07-20
• Study First Posted: 2007-07-23
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 107

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Migraine headache frequency	12 months

Secondary Outcome Measures

Name	Time	Method
Responder rate; Acute migraine medication use; Quality of life evaluations; Effects of Anti-thrombotic medications; Adverse events; PFO Closure	12 months

Trial Locations

Locations (17)

University of Calgary- Foothills Hospital; 🇨🇦 Calgary, Alberta, Canada

Alberta Health Services and the University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

University of Ottawa; 🇨🇦 Ottawa, Ontario, Canada

Davisville Medical Center; 🇨🇦 Toronto, Ontario, Canada

Institut de Cardiologie de Montreal; 🇨🇦 Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Québec; 🇨🇦 Quebec City, Quebec, Canada

Unfallkrankenhaus Berlin; 🇩🇪 Berlin, Germany

Martin-Luther-University Halle-Wittenberg; 🇩🇪 Halle, Germany

Universitätsklinikum Hamburg; 🇩🇪 Hamburg, Germany

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