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ESCAPE Migraine Trial

NCT00267371 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2019-02-04

No results posted yet for this study

Summary

The purpose of this two arm controlled double-blind study is to determine the safety and effectiveness of PFO closure (closing a hole in the wall of the heart) in reducing the frequency of migraine headaches, in patients who experience migraine headaches and have a PFO, compared to medical therapy alone.

Conditions

  • Migraine Disorders
  • Heart Septal Defects, Atrial

Interventions

DEVICE

PFO Closure with Premere investigational device.

PFO Closure with Premere investigational device.

DRUG

Medical management/current medications per standard of care by personal physician.

Medical management with current medications per standard of care by personal physician.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Robert Sommer, MD · Columbia University

  • David Dodick, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States

Study Locations

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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 NCT00267371 on ClinicalTrials.gov