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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 · 3 trials · 3 indications
CSF obtained from lumbar punctures will be used to determine neurofilament light chain levels from baseline to 48 weeks between the active and placebo treated arms.
| Arm | Type | Description |
|---|---|---|
| OxCarbazepine Treatment | EXPERIMENTAL | Treated for 48 weeks with OxCarbazepine 150mg twice a day alongside current DMDs. |
| OxCarbazepine Placebo | PLACEBO_COMPARATOR | Treated for 48 weeks with matched placebo 1 tablet twice a day alongside current DMDs |
| Name | Type | Description |
|---|---|---|
| oxcarbazepine | DRUG | - |
| Placebo | DRUG | Placebo in a matched capsule containing Microcrystalline Cellulose/Magnesium Stearate 1%. |
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...
Top 11 of 16 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Xenon Pharmaceuticals Inc. | XENE | 4 | PHASE3 | Azetukalner |
| Praxis Precision Medicines, Inc. | PRAX | 5 | PHASE3 | Vormatrigine, Elsunersen |
| Rapport Therapeutics, Inc. | RAPP | 4 | PHASE3 | RAP-219 |
| Biohaven Ltd. | BHVN | 3 | PHASE3 | BHV-7000 |
| Stoke Therapeutics, Inc. | STOK | 2 | PHASE3 | zorevunersen |
| Supernus Pharmaceuticals, Inc. | SUPN | 4 | PHASE2 | BIS-001ER, SPN-817 |
| Harmony Biosciences Holdings, Inc. | HRMY | 2 | PHASE3 | Clemizole |
| uniQure N.V. | QURE | 1 | PHASE2 | AMT-260 |
| Bright Minds Biosciences Inc. | DRUG | 1 | PHASE2 | BMB-101 |
| Jazz Pharmaceuticals Public Limited Company | JAZZ | 2 | PHASE1 | CBD-OS, Epidiolex |
| Ionis Pharmaceuticals, Inc. | IONS | 1 | PHASE2 | ION337 |
Oxcarbazepine is a small-molecule neurology drug developed by Novartis AG (ticker NVS). It has been studied in epilepsy and multiple sclerosis and is in Phase 3 development. It is given as an oral small molecule and has been evaluated in pediatric epilepsy trials as well as a multiple sclerosis study.
Oxcarbazepine targets voltage-gated sodium channels, specifically SCN1A, SCN2A, SCN4A, SCN5A, SCN7A, and SCN9A, and acts as a blocker of these channels. Blocking sodium channels reduces neuronal excitability, which is the basis for its use in epilepsy and its investigation in multiple sclerosis.
Oxcarbazepine is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor associated with the clinical development program covering epilepsy and multiple sclerosis indications for this small-molecule neurology asset.
Oxcarbazepine is in Phase 3 development. It is an investigational agent still in clinical development and is not described as FDA approved. Its completed trials include Phase 3 pediatric epilepsy studies and a Phase 2 multiple sclerosis study.
Oxcarbazepine has completed trials including NCT00050947 and NCT00050934, both Phase 3 pediatric epilepsy studies conducted in the United States, Brazil, Germany, and Mexico, and NCT02104661, a Phase 2 study of its protective role in multiple sclerosis in the United Kingdom. Total enrollment across these studies was 226 participants.
Yes. Oxcarbazepine was evaluated in a completed Phase 2 trial, NCT02104661, titled Protective Role of Oxcarbazepine in Multiple Sclerosis, conducted in the United Kingdom with 30 participants. This study examined the drug in multiple sclerosis alongside its larger pediatric epilepsy program.