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oxcarbazepine

Phase 3

Epilepsy | Small molecule | Neurology |Novartis AG|Last Updated: Nov 23, 2011

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
UNCONTROLLEDBiomarker
Total Trials2
Total Enrollment226
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00050947Pediatric Epilepsy StudyPHASE3 COMPLETED 94 — — Jul 1, 2002Feb 1, 2004Nov 23, 201130 United States, Brazil +2
NCT00050934Pediatric Epilepsy StudyPHASE3 COMPLETED 132 — — Jun 1, 2002Jun 1, 2004Nov 23, 201130 United States, Brazil +2
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Study Endpoints
Primary Endpoints
Time to meeting one of the exit criteria starting from the first dose of oxcarbazepine on Day 3.
change in seizure frequency/24 hours (during the last 72 hours in the Treatment Phase compared to Baseline)
Secondary Endpoints
Percentage of patients meeting one of the exit criteria and the electrographic partial seizure frequency/24 hours during the treatment phase
% change in seizure frequency/24 hours; change in seizure frequency/24 hours; response to treatment (at least a 50%, 75%, or 100% reduction seizure frequency/24 hours).
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Study Design & Arms
PurposeTREATMENT
Interventions
NameTypeDescription
oxcarbazepineDRUG -
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Eligibility Criteria
Age Range1 Month — 16 Years
SexALL
Healthy VolunteersNo
Study Sites30

INCLUSION CRITERIA: To enter this study, patients must: * Have a diagnosis of partial seizures * Have 2-30 seizures per week while on a stable dose of one anti-epileptic drug or be a patient recently diagnosed with partial seizures and currently receiving no seizure medication * Be willing to be ho...

Countries:United StatesBrazilGermanyMexico
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Competitive Landscape -Epilepsy 37 trials
CompanyTickerTrialsLead PhaseDrugs
Xenon Pharmaceuticals Inc.XENE4PHASE3XEN1101
Praxis Precision Medicines, Inc.PRAX6PHASE3vormatrogine, elsunersen, PRAX-628, PRAX-222 - Initial Dose, PRAX-222 - Initial Ascending Doses
Rapport Therapeutics, Inc.RAPP3PHASE3RAP-219
NeuroPace, Inc.NPCE2PHASE3Undisclosed
Supernus Pharmaceuticals, Inc.SUPN4PHASE2SPN-817, BIS-001ER
Biohaven Ltd.BHVN3PHASE2BHV-7000
Harmony Biosciences Holdings, Inc.HRMY1PHASE3Clemizole
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE1CBD-OS, Epidiolex /mL, Epidiolex
Bright Minds Biosciences Inc.DRUG1PHASE2BMB-101
uniQure N.V.QURE1PHASE1AAV9-hSyn1-miGRIK2
Boston Scientific CorporationBSX1NAUndisclosed
Tango Therapeutics, Inc.TNGX1PHASE1S230815- Starting dose A, S230815- Dose B, S230815- Dose C, S230815- Dose D
IQVIA Holdings IncIQV1 — Undisclosed
NeuroOne Medical Technologies CorporationNMTC1 — Undisclosed
Unity Health TorontoUBX1NAUndisclosed
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