PRIMA PFO Migraine Trial

Abbott

Status and phase: Terminated; Phase 2

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

Treatments: Device: AMPLATZER® PFO Occluder Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT00505570

AGA010E

Details and patient eligibility

About

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.

Full 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.

Enrollment: 107 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 2 patient groups

Medical Management

No Intervention group

PFO Closure

Experimental group

Treatment:

Device: AMPLATZER® PFO Occluder Device