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STOP PAIN: Septal Closure of PFO - Does it Prevent Migraine?

NCT00369499 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 656

Last updated 2023-06-29

No results posted yet for this study

Summary

The primary objective of this Study is to compare the effect of transcatheter device closure of atrial shunting to a non-closure control group over a period from cessation of procedure related medication at 3 months until 9 months post randomization by determining the proportion of patients that experience a 50% or more reduction in the baseline monthly migraine attack frequency in each group.

Conditions

Interventions

DEVICE

PFO Closure

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Michel Ferrari, Prof. · Leiden University Medical Centre

  • Horst Sievert, Prof. · CardioVascular Center Frankfurt, Sankt Katharinen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-03-31
Completion
2009-06-30

Countries

  • Germany

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 NCT00369499 on ClinicalTrials.gov