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oxcarbazepine

Phase 4FDA approved

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

oxcarbazepine development status

FDA approval on record Jan 14, 2000
Approval holderNovartis
ApplicationNDA021014
Highest phase Phase 4 (NCT00154323)
Phase scored for NVSPhase 3
Registered trials 9 across 4 sponsors since Jan 2003

Label indication TRILEPTAL is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. FDA label

oxcarbazepine target and mechanism

Molecular targetSCN1A, SCN5A, SCN4A, SCN7A, SCN2A, SCN9A
Target classBlocker
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment226

FDA Designations

No designations recorded

oxcarbazepine clinical trials

oxcarbazepine · 2 trials · 2 indications

Phase 3 2
NCT00050947Pediatric Epilepsy StudyEpilepsy
COMPLETED94 Analytics
NCT00050934Pediatric Epilepsy StudyEpilepsy
COMPLETED132 Analytics
PHASE3COMPLETED
Pediatric Epilepsy Study
EpilepsyUnlock trial analytics
PHASE3COMPLETED
Pediatric Epilepsy Study
EpilepsyUnlock trial analytics

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 to 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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Frequently asked questions about oxcarbazepine

What is oxcarbazepine used for?

Oxcarbazepine is used for epilepsy. It is a small molecule developed by Novartis AG for the neurology therapeutic area. The clinical program has studied it in epilepsy, including partial epilepsies, in pediatric patients. Two Phase 3 trials in epilepsy have been completed, enrolling a total of 226 participants.

What does oxcarbazepine target?

Oxcarbazepine targets sodium channel proteins SCN1A, SCN5A, SCN4A, SCN7A, SCN2A, and SCN9A. It acts as a blocker of these targets. This target class is consistent with its development as a small molecule for epilepsy under Novartis AG.

Who makes oxcarbazepine?

Oxcarbazepine is developed by Novartis AG, which trades under the ticker NVS. Novartis is the company associated with the clinical development program for oxcarbazepine in epilepsy.

What phase is oxcarbazepine in?

Oxcarbazepine is in Phase 3 clinical development for epilepsy. Two Phase 3 trials have been completed, and no trials are currently active. The program has enrolled 226 participants in total across those completed studies.

What clinical trials is oxcarbazepine in?

Oxcarbazepine has been studied in two completed Phase 3 pediatric epilepsy trials: NCT00050947, which enrolled 94 participants, and NCT00050934, which enrolled 132 participants and included partial epilepsies. Both trials were conducted in the United States, Brazil, Germany, and Mexico, and enrolled participants from one month of age.