Overview

This trial is active, not recruiting.

Conditions migraine, aura, patent foramen ovale
Treatments biostar septal repair implant system, sham procedure
Phase phase 2/phase 3
Sponsor NMT Medical
Start date February 2006
End date March 2008
Trial size 610 participants
Trial identifier NCT00283738, G050119, MIST II

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
biostar septal repair implant system
PFO Closure
(Placebo Comparator)
Sham control
sham procedure
Catheterization

Primary Outcomes

Measure
Efficacy: Migraine reduction rates during analysis period.
time frame:
Safety: Incidence of Major Adverse Cardiac Events (MACE) one year post-implantation.
time frame:

Secondary Outcomes

Measure
Efficacy:Change in number of attacks from baseline period compared to analysis phase.
time frame:
Safety: Device success during index procedure without procedural complication.
time frame:
Incidence of major AEs during index procedure and post-procedure as they relate to the device and protocol specified medications.
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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.

Additional Information

Official title A Prospective, Multi-Center, Double-Blinded, Placebo-Controlled Trial to Evaluate the Effectiveness of Patent Foramen Ovale Closure With the BioSTAR Septal Repair Implant to Reduce Refractory Migraine Headache With Aura.
Principal investigator Mark Reisman, MD
Description During the last five years, transcatheter and surgical closure of PFO in the cyrptogenic stroke and TIA population has grown in frequency world-wide. Observational retrospective reports, from both single and multi-center experiences of over 400 patients, suggest Patent Foramen Ovale (PFO) closure to reduce the risk of recurrent migraine events in these populations may be beneficial, particularly for those patients in the migraine with aura subgroup. Although none of these reports are from prospective, randomized, controlled trials, the reports are compelling enough in their totality to support further investigation of a well defined group in a prospective manner. The patients reported in these studies were brought to PFO closure with no expectation of their procedure having any impact on their migraine. In fact, in many cases, the discovery of a history of migraine was not made until well after the PFO closure procedure. This clinical trial will prospectively compare the safety and effectiveness of PFO closure with the BioSTAR device to a control arm. Patients will be followed one year post-implant.
Trial information was received from ClinicalTrials.gov and was last updated in January 2008.
Information provided to ClinicalTrials.gov by NMT Medical.