MedTrace Logo

PRIMA PFO Migraine Trial

NCT00505570 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2019-02-04

No results posted yet for this study

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.

Conditions

  • Migraine
  • Migraine With Aura
  • Patent Foramen Ovale
  • PFO

Interventions

DEVICE

AMPLATZER® PFO Occluder Device

PFO device closure

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Prima Trial Steering Committee

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • Canada
  • Germany
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00505570 on ClinicalTrials.gov