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oxcarbazepine

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment226

FDA Designations

No designations recorded

Clinical trial landscape

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 the treatment of epilepsy. It is a small molecule developed by Novartis AG (NYSE: NVS) and is currently in Phase 3 clinical development for this indication. The drug is being studied in pediatric populations with epilepsy, including partial epilepsies.

Who makes oxcarbazepine?

Oxcarbazepine is developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is being investigated for the treatment of epilepsy and is currently in Phase 3 clinical trials.

What phase is oxcarbazepine in?

Oxcarbazepine is in Phase 3 clinical development for epilepsy. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. Two Phase 3 trials have been completed, with a total of 226 participants enrolled across multiple countries.

What clinical trials is oxcarbazepine in?

Oxcarbazepine has been studied in two completed Phase 3 clinical trials: NCT00050934 and NCT00050947, both titled 'Pediatric Epilepsy Study'. These trials enrolled 132 and 94 participants respectively, including children as young as 1 month old, across the United States, Brazil, Germany, and Mexico.

Is oxcarbazepine FDA approved?

Oxcarbazepine is not FDA approved for the indication being studied. It is currently in Phase 3 clinical development, with two completed trials in pediatric epilepsy. The drug remains investigational and has not received regulatory approval for this use.