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Bioabsorbable Implant

1 for Migraine

Phase 2 & 3
Waitlist Available
Led By Stewart J. Tepper, MD
Research Sponsored by NMT Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
age between 18 and 60.
migraine history prior to age 50
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study 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.

Eligible Conditions
  • Migraine
  • Migraine Aura
  • Patent Foramen Ovale

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy: Migraine reduction rates during analysis period.
Safety: Incidence of Major Adverse Cardiac Events (MACE) one year post-implantation.
Secondary outcome measures
Efficacy:Change in number of attacks from baseline period compared to analysis phase.
Incidence of major AEs during index procedure and post-procedure as they relate to the device and protocol specified medications.
Safety: Device success during index procedure without procedural complication.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: 1Active Control1 Intervention
Group II: 2Placebo Group1 Intervention
Sham control

Find a Location

Who is running the clinical trial?

NMT MedicalLead Sponsor
1 Previous Clinical Trials
900 Total Patients Enrolled
Stewart J. Tepper, MDPrincipal InvestigatorDirector of the New England Center for Headache
Mark Reisman, MDPrincipal InvestigatorSwedish Medical Center, Seattle, WA
3 Previous Clinical Trials
1,312 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~32 spots leftby Mar 2025