Migraine Clinical Trial
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.
Verified date | January 2008 |
Source | NMT Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 610 |
Est. completion date | March 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Swedish Medical Center | Seattle | Washington |
United States | New England Center for Headache | Stamford | Connecticut |
Lead Sponsor | Collaborator |
---|---|
NMT Medical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy: Migraine reduction rates during analysis period. | |||
Primary | Safety: Incidence of Major Adverse Cardiac Events (MACE) one year post-implantation. | |||
Secondary | Efficacy:Change in number of attacks from baseline period compared to analysis phase. | |||
Secondary | Safety: Device success during index procedure without procedural complication. | |||
Secondary | Incidence of major AEs during index procedure and post-procedure as they relate to the device and protocol specified medications. |
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