PRIMA PFO Migraine Trial

Migraine Clinical Trial

— PRIMA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00505570
• Other study ID #: AGA010E
• Status: Terminated
• Phase: Phase 2
• Start date: May 2006
• Est. completion date: February 2013

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 107
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Migraine
• Migraine Disorders
• Migraine with Aura
• Patent Foramen Ovale
• PFO

Intervention

Device:
• AMPLATZER® PFO Occluder Device
PFO device closure

Locations

Country	Name	City	State
Canada	University of Calgary- Foothills Hospital	Calgary	Alberta
Canada	Alberta Health Services and the University of Alberta	Edmonton	Alberta
Canada	Institut de Cardiologie de Montreal	Montreal	Quebec
Canada	University of Ottawa	Ottawa	Ontario
Canada	Centre Hospitalier Universitaire de Québec	Quebec City	Quebec
Canada	Davisville Medical Center	Toronto	Ontario
Canada	University of British Columbia	Vancouver	British Columbia
Germany	Unfallkrankenhaus Berlin	Berlin
Germany	Martin-Luther-University Halle-Wittenberg	Halle
Germany	Universitätsklinikum Hamburg	Hamburg
Germany	Neurologisch-verhaltensmedizinische Schmerzklinik Kiel	Kiel
Germany	Universitätsklinikum Münster	Münster
Switzerland	Swiss Cardiovascular Center Bern	Bern
Switzerland	Kopfwehzentrum Hirslanden Zürich	Zürich
United Kingdom	Royal Sussex County Hospital	Brighton
United Kingdom	St. Mary's Hospital Imperial College Healthcare NHS Trust	London
United Kingdom	South Manchester University Hospital	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Canada,  Germany,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migraine headache frequency		12 months
Secondary	Responder rate; Acute migraine medication use; Quality of life evaluations; Effects of Anti-thrombotic medications; Adverse events; PFO Closure		12 months