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Oxcarbazepine

Generic Name
Oxcarbazepine
Brand Names
Oxtellar, Trileptal
Drug Type
Small Molecule
Chemical Formula
C15H12N2O2
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

EXTENT: EXtended Tolerability and Efficacy of a Novel Formulation of Oxcarbazepine in a Trial in Partial Epilepsy

First Posted Date
2006-10-24
Last Posted Date
2010-04-15
Lead Sponsor
Desitin Arzneimittel GmbH
Target Recruit Count
100
Registration Number
NCT00391534

Efficacy, Safety, and Tolerability of Oxcarbazepine Monotherapy in Children With Partial Seizures

Phase 4
Completed
Conditions
Epilepsy, Partial Seizures
First Posted Date
2006-01-12
Last Posted Date
2017-02-23
Lead Sponsor
Novartis
Target Recruit Count
60
Registration Number
NCT00275912
Locations
🇷🇺

Russian State Medical University clinically based on Russian Pediatric Clinical Hospital, Moscow, Russian Federation

🇷🇺

Regional Pediatric Clinical Hospital №1 EkaterinburgRegional Pediatric Clinical Hospital №1, Ekaterinburg, Russian Federation

🇷🇺

Moscow Scientific Research Institute of Pediatrics and Pediatric Surgery, Moscow, Russian Federation

and more 2 locations

Safety and Efficacy of Oxcarbazepine Monotherapy in Adults With Partial Seizures

Phase 4
Completed
Conditions
Epilepsy, Partial Seizures
First Posted Date
2006-01-12
Last Posted Date
2007-11-30
Lead Sponsor
Novartis
Target Recruit Count
80
Registration Number
NCT00275925
Locations
🇷🇺

Neurology and Neurosurgery Department of the Russian State Medical University, Moscow, Russian Federation

🇷🇺

Neurology and Neurosurgery Department of the Moscow State Medico-stomatology University, Moscow, Russian Federation

🇷🇺

Neurology Department of the Moscow region Research Institute named after M.F. Vladimirskiy, Moscow, Russian Federation

and more 4 locations

The Efficacy and Safety of Oral Oxcarbazepine 300-1200 mg/Day as Adjuvant Therapy in the Treatment of Bipolar Disorder I or II This Study is Not Being Conducted in the United States.

Phase 4
Completed
Conditions
Bipolar Disorder
First Posted Date
2005-09-12
Last Posted Date
2023-12-14
Lead Sponsor
Novartis
Target Recruit Count
55
Registration Number
NCT00154323

The Efficacy and Safety of Oral Oxcarbazepine 300-1200 mg/Day as Adjuvant Therapy in the Treatment of Adolescents With Impulsivity and Aggressive Behavior in Conduct Disorder This Study is Not Being Conducted in the United States.

Phase 4
Completed
Conditions
Conduct Disorder
First Posted Date
2005-09-12
Last Posted Date
2011-11-24
Lead Sponsor
Novartis
Target Recruit Count
50
Registration Number
NCT00154362

The Effect of Oxcarbazepine in the Treatment of Agitation / Aggression in Dementia (OBAD)

Phase 3
Completed
Conditions
Agitation Aggression in Dementia
First Posted Date
2005-09-05
Last Posted Date
2007-03-21
Lead Sponsor
Sykehuset Innlandet HF
Target Recruit Count
100
Registration Number
NCT00145691
Locations
🇳🇴

Sykehuset Innlandet HF, Reinsvoll, Oppland, Norway

Study of Efficacy of Oxcarbazepine in Therapy of Bronchial Asthma

Phase 4
Completed
Conditions
Bronchial Asthma
First Posted Date
2005-09-02
Last Posted Date
2009-02-19
Lead Sponsor
Centre of Chinese Medicine, Georgia
Target Recruit Count
55
Registration Number
NCT00142025

Pediatric Epilepsy Study

Phase 3
Completed
Conditions
Epilepsy
Epilepsies, Partial
First Posted Date
2003-01-01
Last Posted Date
2011-11-23
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
132
Registration Number
NCT00050934
Locations
🇲🇽

Novartis, Mexico City, Mexico

🇧🇷

Brigadeiro Hospital, Sao Paulo - SP, Brazil

Pediatric Epilepsy Study

Phase 3
Completed
Conditions
Epilepsy
First Posted Date
2003-01-01
Last Posted Date
2011-11-23
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
94
Registration Number
NCT00050947
Locations
🇲🇽

Novartis, Mexico City, Mexico

🇧🇷

Brigadeiro Hospital, Sao Paulo - SP, Brazil

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