Oxcarbazepine

Generic Name: Oxcarbazepine

Brand Names: Oxtellar, Trileptal

Drug Type: Small Molecule

Chemical Formula: C_₁₅H_₁₂N_₂O_₂

CAS Number: 28721-07-5

Unique Ingredient Identifier: VZI5B1W380

Background: Oxcarbazepine is an anti-epileptic medication used in the treatment of partial onset seizures that was first approved for use in the United States in 2000. It is a structural derivative of carbamazepine and exerts a majority of its activity via a pharmacologically active metabolite, MHD, which exists as a racemate in the blood - a pro-drug of the more active (S)-enantiomer is also marketed as a separate anti-epileptic under the name eslicarbazepine. Compared to other anti-epileptic drugs, which are generally metabolized via the cytochrome P450 system, oxcarbazepine has a reduced propensity for involvement in drug-drug interactions owing to its primarily reductive metabolism.

Indication: In the United States, oxcarbazepine 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.

In Canada, oxcarbazepine is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in patients 6 years of age and older.

Associated Conditions: Partial-Onset Seizures

Associated Therapies: Monotherapy

Clinical Trials

Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions

Phase 1

Completed

Conditions: Seizures

Interventions: Drug: Oxcarbazepine

First Posted Date: 2012-10-08

Last Posted Date: 2018-01-23

Lead Sponsor: Roxane Laboratories

Target Recruit Count: 64

Registration Number: NCT01702623

Locations: 🇺🇸
Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research), San Antonio, Texas, United States

Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in Healthy Volunteers

Phase 1

Completed

Conditions: Epilepsy

Interventions: Drug: BIA 2-093
Drug: Oxcarbazepine

First Posted Date: 2012-09-05

Last Posted Date: 2015-01-08

Lead Sponsor: Bial - Portela C S.A.

Target Recruit Count: 13

Registration Number: NCT01678976

Locations: 🇵🇹
BIAL - Portela & Cª - Human Pharmacology Unit (UFH), S. Mamede do Coronado, Trofa, Portugal

Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers

Phase 1

Completed

Conditions: Epilepsy

Interventions: Drug: BIA 2-093
Drug: Oxcarbazepine

First Posted Date: 2012-09-05

Last Posted Date: 2025-04-06

Lead Sponsor: Bial - Portela C S.A.

Target Recruit Count: 12

Registration Number: NCT01679002

Locations: 🇵🇹
BIAL - Portela & Cª S.A. - Human Pharmacology Unit (UFH), S. Mamede Do Coronado, Trofa, Portugal

Levetiracetam Versus Oxcarbazepine as Monotherapy to Evaluate Efficacy and Safety in Subjects With Newly or Recently Diagnosed Partial Epilepsy

Phase 4

Completed

Conditions: Epilepsy

Interventions: Drug: Levetiracetam
Drug: Oxcarbazepine

First Posted Date: 2011-12-23

Last Posted Date: 2015-08-20

Lead Sponsor: Korea UCB Co., Ltd.

Target Recruit Count: 353

Registration Number: NCT01498822

Locations: 🇰🇷
05, Busan, Korea, Republic of
🇰🇷
10, Busan, Korea, Republic of
🇰🇷
16, Busan, Korea, Republic of

and more 20 locations

Oxcarbazepine for the Treatment of Chronic Peripheral Neuropathic Pain

Phase 4

Completed

Conditions: Polyneuropathy
Peripheral Nerve Injury
Postherpetic Neuralgia

Interventions: Drug: Oxcarbazepine

First Posted Date: 2011-02-24

Last Posted Date: 2014-05-05

Lead Sponsor: Søren H. Sindrup

Target Recruit Count: 117

Registration Number: NCT01302275

Locations: 🇩🇰
Danish Pain Research Center, Aarhus University Hospital, Aarhus, Denmark
🇩🇰
Department of Neurology, Odense University Hospital, Odense, Denmark