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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
Also known as Oxcarbazepine XR
Oxcarbazepine · 1 trial · 1 indication
Measured as change from baseline to end of study
| Arm | Type | Description |
|---|---|---|
| Oxcarbazepine XR | OTHER | Open Label Study |
| Name | Type | Description |
|---|---|---|
| Oxcarbazepine XR | DRUG | Open Label Study |
Inclusion Criteria 1. Able to provide written informed consent and agree to comply with study procedures. 2. Male or female aged 18 to 66 years, inclusive. 3. Successful completion of the 804P301 study. 4. Sexually active women, unless surgically sterile (at least 6 months prior to Study Medication...
Oxcarbazepine is used for the treatment of partial epilepsy. It is being developed as an adjunctive therapy for patients with refractory partial epilepsy, meaning seizures that have not been adequately controlled by other treatments. Supernus Pharmaceuticals is developing an extended-release formulation under the name Oxcarbazepine XR.
Oxcarbazepine targets voltage-gated sodium channels, specifically SCN1A, SCN2A, SCN4A, SCN5A, SCN7A, and SCN9A. It acts as a blocker of these channels. By blocking sodium channels, Oxcarbazepine is thought to reduce the abnormal electrical activity in the brain that leads to seizures in partial epilepsy.
Oxcarbazepine is being developed by Supernus Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker symbol SUPN. Supernus is the company responsible for the development of the extended-release formulation known as Oxcarbazepine XR.
Oxcarbazepine is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 3 program includes a completed trial evaluating the safety and tolerability of Oxcarbazepine XR as adjunctive therapy in patients with refractory partial epilepsy.
Oxcarbazepine has been studied in a Phase 3 trial, NCT00908349, titled "Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy." This completed trial enrolled 214 participants across the United States, Bulgaria, Canada, Croatia, Mexico, Poland, Romania, and Russia. It was an uncontrolled study in adults aged 18 years and older.
Yes, Oxcarbazepine XR is an alternative name for Oxcarbazepine. The XR designation refers to the extended-release formulation developed by Supernus Pharmaceuticals. Both names refer to the same active ingredient, oxcarbazepine, which is a small molecule sodium channel blocker being studied for partial epilepsy.