PRIMA PFO Migraine Trial

Phase 2

Terminated

• Conditions: Patent Foramen Ovale; PFO; Migraine With Aura; Migraine
• Interventions: Device: AMPLATZER® PFO Occluder Device

• 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

Arm && Interventions

Group	Intervention	Description
PFO Closure	AMPLATZER® PFO Occluder Device	-

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)

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

Royal Sussex County Hospital; 🇬🇧 Brighton, United Kingdom

University of Ottawa; 🇨🇦 Ottawa, Ontario, Canada

South Manchester University Hospital; 🇬🇧 Manchester, United Kingdom

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

St. Mary's Hospital Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom

Universitätsklinikum Münster; 🇩🇪 Münster, Germany

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

Universitätsklinikum Hamburg; 🇩🇪 Hamburg, Germany

Neurologisch-verhaltensmedizinische Schmerzklinik Kiel; 🇩🇪 Kiel, Germany

Davisville Medical Center; 🇨🇦 Toronto, Ontario, Canada

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

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

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

Swiss Cardiovascular Center Bern; 🇨🇭 Bern, Switzerland

Unfallkrankenhaus Berlin; 🇩🇪 Berlin, Germany

Kopfwehzentrum Hirslanden Zürich; 🇨🇭 Zürich, Switzerland