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external Responsive Neurostimulator System

Phase 2

Epilepsy | Unknown | Neurology |Neuropace, Inc.|Last Updated: Aug 26, 2010

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00158067Study of an External Responsive Neurostimulator System on Epileptiform ActivityPHASE2 COMPLETED 150Mar 1, 2002Mar 1, 2008Aug 26, 20105 United States
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
external Responsive Neurostimulator (eRNS) SystemDEVICE -
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Subject is undergoing evaluation for epilepsy surgery in a manner consistent with the Surgery for Epilepsy, NIH Consensus Statement, 1990 Mar 19-21; 8(2); 1-20. * Subject is implanted with intracranial electrodes. * Subject is under constant medical supervision while implanted...

Countries:United States
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