PRIMA PFO Migraine Trial

Phase 2TerminatedNCT00505570

Abbott Medical Devices107 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

107

Conditions

Migraine Migraine With Aura Patent Foramen Ovale PFO

Interventions

AMPLATZER® PFO Occluder DeviceDEVICE

PFO device closure

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (17)

University of Calgary- Foothills Hospital

Calgary, Alberta, Canada

Alberta Health Services and the University of Alberta

Edmonton, Alberta, Canada

Outcomes

Primary Outcomes

Migraine headache frequency

Time frame: 12 months

Secondary Outcomes

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

Time frame: 12 months

Data from ClinicalTrials.gov

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