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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

Long Term Study of the Safety of OXC XR as in Pediatric Epilepsy Subjects

Conditions
Epilepsy
First Posted Date
2009-06-11
Last Posted Date
2017-05-09
Lead Sponsor
Supernus Pharmaceuticals, Inc.
Registration Number
NCT00918424
Locations
🇺🇸

Site 03, Loxahatchee Groves, Florida, United States

🇺🇸

Site 07, San Antonio, Texas, United States

🇺🇸

Site 05, Rochester, New York, United States

and more 1 locations

Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy

Phase 3
Completed
Conditions
Partial Epilepsy
Interventions
First Posted Date
2009-05-25
Last Posted Date
2017-05-31
Lead Sponsor
Supernus Pharmaceuticals, Inc.
Target Recruit Count
214
Registration Number
NCT00908349

Study to Evaluate Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine

Phase 1
Completed
Conditions
Partial Epilepsy
Interventions
First Posted Date
2009-05-12
Last Posted Date
2014-12-19
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
14
Registration Number
NCT00900237
Locations
🇧🇪

SGS LSS Clinical Pharmacology Unit Antwerpen, Antwerpen, Belgium

Oxcarbazepine 600 mg Tablets Under Fasting Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2009-02-24
Last Posted Date
2024-08-19
Lead Sponsor
Teva Pharmaceuticals USA
Target Recruit Count
60
Registration Number
NCT00850174
Locations
🇨🇦

Pharma Medica Research Inc., Toronto, Ontario, Canada

Oxcarbazepine 600 mg Tablets Under Non-Fasting Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2009-02-24
Last Posted Date
2024-08-19
Lead Sponsor
Teva Pharmaceuticals USA
Target Recruit Count
120
Registration Number
NCT00849797
Locations
🇨🇦

SFBC Anapharm, Montreal, Quebec, Canada

Oxcarbazepine as an Adjunct of Antipsychotic Therapy in Acute Schizophrenia

Phase 2
Completed
Conditions
Schizophrenia
Interventions
Drug: Placebo
First Posted Date
2008-03-17
Last Posted Date
2008-07-24
Lead Sponsor
University of Cologne
Target Recruit Count
54
Registration Number
NCT00637234
Locations
🇩🇪

Isar-Amper-Klinikum gemeinnützige GmbH, Klinik Taufkirchen (Vils), Taufkirchen (Vils), Bayern, Germany

🇩🇪

University of Cologne, Dept. of Psychiatry and Psychotherapy, Cologne, NRW, Germany

Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions

Not Applicable
Completed
Conditions
Seizures
Epilepsy
First Posted Date
2008-02-18
Last Posted Date
2018-01-23
Lead Sponsor
Roxane Laboratories
Target Recruit Count
48
Registration Number
NCT00618046
Locations
🇺🇸

Bio-Kinetics Clinical Applications, Inc ., Springfield, Missouri, United States

Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions

Not Applicable
Completed
Conditions
Seizures
Epilepsy
First Posted Date
2008-02-15
Last Posted Date
2018-01-23
Lead Sponsor
Roxane Laboratories
Target Recruit Count
28
Registration Number
NCT00616863
Locations
🇨🇦

MDS Pharma Services, Montreal, Quebec, Canada

Bioequivalency Study of 600 mg Oxcarbazepine Tablets Under Fasting Conditions

Not Applicable
Completed
Conditions
Seizures
Epilepsy
First Posted Date
2008-02-15
Last Posted Date
2018-01-23
Lead Sponsor
Roxane Laboratories
Target Recruit Count
28
Registration Number
NCT00616681
Locations
🇨🇦

MDS Pharma Services, Montreal, Quebec, Canada

Oxcarbazepine Versus Placebo in Childhood Autism

Not Applicable
Completed
Conditions
Autism
Interventions
Other: Placebo/sugar pill
First Posted Date
2007-05-01
Last Posted Date
2021-01-13
Lead Sponsor
University of Medicine and Dentistry of New Jersey
Target Recruit Count
5
Registration Number
NCT00467753
Locations
🇺🇸

Child and Adolescent Psychiatry at the University Behavioral Healthcare Building, UMDNJ-RWJMS, Piscataway, New Jersey, United States

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