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Eslicarbazepine acetate

Generic Name
Eslicarbazepine acetate
Brand Names
Aptiom, Zebinix
Drug Type
Small Molecule
Chemical Formula
C17H16N2O3
CAS Number
236395-14-5
Unique Ingredient Identifier
BEA68ZVB2K
Background

Eslicarbazepine acetate (ESL) is an anticonvulsant medication approved for use in Europe, the United States and Canada as an adjunctive therapy for partial-onset seizures that are not adequately controlled with conventional therapy. Eslicarbazepine acetate is a prodrug that is rapidly converted to eslicarbazepine, the primary active metabolite in the body. Eslicarbazepine's mechanism of action is not well understood, but it is known that it does exert anticonvulsant activity by inhibiting repeated neuronal firing and stabilizing the inactivated state of voltage-gated sodium channels, thus preventing their return to the activated state during which seizure activity can occur.

Eslicarbazepine acetate is marketed as Aptiom in North America and Zebinix or Exalief in Europe. It is available in 200, 400, 600, or 800mg tablets that are taken once daily, with or without food. Eslicarbazepine acetate is associated with numerous side effects including dizziness, drowsiness, nausea, vomiting, diarrhea, headache, aphasia, lack of concentration, psychomotor retardation, speech disturbances, ataxia, depression and hyponatremia. It is recommended that patients taking eslicarbazepine acetate be monitored for suicidality.

Indication

Eslicarbazepine acetate is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.

Associated Conditions
Partial-Onset Seizures
Associated Therapies
-

A Study of a Drug to be Used in Addition With Another Drug to Treat Adults With Uncontrolled Partial-onset Seizures

Phase 4
Completed
Conditions
Epilepsy With Partial On-set Seizures
Interventions
First Posted Date
2017-04-17
Last Posted Date
2020-06-16
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
102
Registration Number
NCT03116828
Locations
🇺🇸

Temple University Lewis Katz School of Medicine, Philadelphia, Pennsylvania, United States

🇺🇸

Aston Ambulatory Care Center, Dallas, Texas, United States

🇺🇸

Northwestern Medical Group, Deparment of Neurology, Chicago, Illinois, United States

and more 52 locations

A Pediatric Drug Study to Determine the Long-term Safety and Tolerability in Children and Adolescents (4-17 Years in Age) Taking the Drug

Phase 3
Withdrawn
Conditions
Epilepsy
Interventions
First Posted Date
2017-04-11
Last Posted Date
2018-01-16
Lead Sponsor
Sumitomo Pharma America, Inc.
Registration Number
NCT03108729
Locations
🇺🇸

Child Neurology Specialists / Clinical Research Center of Nevada, LLC, Henderson, Nevada, United States

Open-label Drug Interaction Study Between Eslicarbazepine Acetate and Lamotrigine.

Phase 1
Completed
Conditions
Epilepsy
Interventions
First Posted Date
2014-11-05
Last Posted Date
2014-11-05
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
32
Registration Number
NCT02283801

The Effect of BIA 2-093 on the Steady-state Pharmacokinetic Profile of Phenytoin in Patients

Phase 1
Terminated
Conditions
Epilepsy
Interventions
First Posted Date
2013-06-17
Last Posted Date
2014-02-27
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
4
Registration Number
NCT01878578
Locations
🇵🇹

Neurology Department, Hospital of Santa Maria, Lisbon, Portugal

Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) in Acute Manic Episodes Associated With Bipolar I Disorder

Phase 2
Completed
Conditions
Bipolar I Disorder
Interventions
First Posted Date
2013-04-02
Last Posted Date
2014-03-27
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
161
Registration Number
NCT01822678

Eslicarbazepine Acetate as Add-On Treatment to One Baseline Antiepileptic Drug (ESLADOBA)

Completed
Conditions
Epilepsy
Interventions
First Posted Date
2012-02-14
Last Posted Date
2017-01-06
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
56
Registration Number
NCT01532726
Locations
🇵🇹

Hospital Fernando da Fonseca, Lisboa, Portugal

Safety and Efficacy of Eslicarbazepine Acetate as Adjunctive Therapy for Partial Seizures in Elderly Patients

Phase 3
Completed
Conditions
Epilepsy
Interventions
First Posted Date
2011-08-24
Last Posted Date
2017-08-07
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
72
Registration Number
NCT01422720
Locations
🇵🇹

Centro Hospitalar de Trás-os -Montes e Alto-Douro, EPE - Hospital de São Pedro - Serviço de Neurologia, Vila Real, Portugal

🇷🇴

Sc Clubul Sanatatii Srl, Campulung Muscel, Romania

🇷🇴

Spitalul Clinic de Neuropsihiatrie Craiova, Craiova; Jud. Dolj, Romania

and more 45 locations

Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children

Phase 3
Completed
Conditions
Partial Epilepsy in Children and Adolescents
Interventions
First Posted Date
2009-10-02
Last Posted Date
2018-11-13
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
304
Registration Number
NCT00988156
Locations
🇦🇹

Ambulanz für Neuropädiatrie und Entwicklungsdiagnostik, Med. Univ. Graz, Graz, Austria

🇭🇷

Clinical hospital Osjek Pediatric clinic, neuropediatric department, Osijek, Croatia

🇩🇪

Epilepsiezentrum Kehl-Kork Kinderklinik Anfallsambulanz für Kinder und jugendliche, Kehl-Kork, Germany

and more 87 locations

Effect of Repeated Administration of Eslicarbazepine Acetate on the Pharmacokinetics of Simvastatin in Healthy Subjects

Phase 1
Completed
Conditions
Epilepsy
Interventions
First Posted Date
2009-10-01
Last Posted Date
2015-01-13
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
30
Registration Number
NCT00987558
Locations
🇫🇷

Biotrial, 7-9 rue Jean-Louis Bertrand, Rennes, France

Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Post-Herpetic Neuralgia

Phase 2
Completed
Conditions
Postherpetic Neuralgia
Interventions
First Posted Date
2009-09-22
Last Posted Date
2014-10-29
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
567
Registration Number
NCT00981227
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