NCT00283738

Brief Summary

The objective of the study is to investigate the safety and effectiveness of PFO closure with the BioSTAR Septal Repair Implant System in a population of patients that have refractory migraine (with aura) and who have failed medications.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
610

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2006

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

January 25, 2008

Status Verified

January 1, 2008

First QC Date

January 27, 2006

Last Update Submit

January 23, 2008

Conditions

MigraineAuraPatent Foramen Ovale

Keywords

migraineauraPatent Foramen Ovale (PFO)cardiac defectsHeart Septal Defects, AtrialCephalalgia

Outcome Measures

Primary Outcomes (2)

  • Efficacy: Migraine reduction rates during analysis period.

  • Safety: Incidence of Major Adverse Cardiac Events (MACE) one year post-implantation.

Secondary Outcomes (3)

  • Efficacy:Change in number of attacks from baseline period compared to analysis phase.

  • Safety: Device success during index procedure without procedural complication.

  • Incidence of major AEs during index procedure and post-procedure as they relate to the device and protocol specified medications.

Study Arms (2)

1

ACTIVE COMPARATOR
Device: BioSTAR Septal Repair Implant System

2

PLACEBO COMPARATOR

Sham control

Procedure: Sham Procedure

Interventions

BioSTAR Septal Repair Implant SystemDEVICE

PFO Closure

1
Sham ProcedurePROCEDURE

Catheterization

2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age between 18 and 60.
  • migraine history prior to age 50
  • must meet definition of refractory migraine with aura
  • must have a Patent Foramen Ovale (PFO) within bubble study specifications.
  • must provide informed consent. Guardian consent is not accepted.
  • patient's heart structure and vasculature must be compatible with BioSTAR Septal Repair Implant System.
  • patient must not be pregnant and agrees not to become pregnant during study participation

You may not qualify if:

  • Medical conditions or medications that are not compatible with protocol or that would increase the patient's risk.
  • patient must not have any cardiac or vascular anomalies, repaired or not, that would be incompatible with the delivery system or device for PFO occlusion.
  • Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current trial endpoints.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

New England Center for Headache

Stamford, Connecticut, 06902, United States

Location

Swedish Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Migraine DisordersEpilepsyForamen Ovale, PatentHeart Septal Defects, AtrialHeadache

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHeart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mark Reisman, MD

    Swedish Medical Center, Seattle, WA

    PRINCIPAL INVESTIGATOR

  • Stewart J. Tepper, MD

    Director of the New England Center for Headache

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 27, 2006

First Posted

January 30, 2006

Study Start

February 1, 2006

Study Completion

March 1, 2008

Last Updated

January 25, 2008

Record last verified: 2008-01

Locations

US(2)