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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 belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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
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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
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