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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
-

Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Painful Diabetic Neuropathy

Phase 2
Completed
Conditions
Painful Diabetic Neuropathy
Interventions
First Posted Date
2009-09-21
Last Posted Date
2016-06-22
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
557
Registration Number
NCT00980746

Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Metformin in Healthy Volunteers

Phase 1
Completed
Conditions
Neuropathic Pain
Interventions
First Posted Date
2009-09-03
Last Posted Date
2014-12-16
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
20
Registration Number
NCT00971295
Locations
🇵🇹

Human Pharmacology Unit (UFH)Section of Clinical Research (SIC), Department of Research & Development (DID), BIAL - Portela & Cª, SA,, Mamede do Coronado, Portugal

Efficacy and Safety Study of BIA 2-093 in Combination With Other Anti-Epileptic Drugs to Treat Partial Epilepsy

Phase 3
Completed
Conditions
Partial Epilepsy
Interventions
First Posted Date
2009-08-12
Last Posted Date
2014-07-02
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
395
Registration Number
NCT00957047
Locations
🇵🇹

Bial - Portela & Cª, S.A., S. Mamede do Coronado, Portugal

Efficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial Epilepsy

Phase 3
Completed
Conditions
Partial Epilepsy
Interventions
First Posted Date
2009-08-12
Last Posted Date
2014-07-02
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
253
Registration Number
NCT00957372
Locations
🇵🇹

Bial - Portela & Cª, S.A., S. Mamede do Coronado, Portugal

Efficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial Seizures

Phase 3
Completed
Conditions
Refractory Partial Epilepsy
Interventions
First Posted Date
2009-08-12
Last Posted Date
2014-07-02
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
402
Registration Number
NCT00957684
Locations
🇵🇹

Bial - Portela & Cª, S.A., S. Mamede do Coronado, Portugal

Eslicarbazepine Acetate Monotherapy Long Term Study

Phase 3
Completed
Conditions
Epilepsy
Interventions
First Posted Date
2009-05-29
Last Posted Date
2018-07-17
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
274
Registration Number
NCT00910247
Locations
🇺🇸

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

🇺🇸

Texas Neurology, PA, Dallas, Texas, United States

🇺🇸

Johns Hopkins University, Baltimore, Maryland, United States

and more 117 locations

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

Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects With Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs

Phase 3
Completed
Conditions
Epilepsy With Simple or Complex Partial Onset Seizures
Interventions
First Posted Date
2009-03-20
Last Posted Date
2016-03-11
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
193
Registration Number
NCT00866775
Locations
🇺🇸

Faculty of Physicians & Surgeons of Loma Linda University, Loma Linda, California, United States

🇺🇸

Institute of Neurology and Neurosurgery at St. Bamabas, Suite 101, Livingston, New Jersey, United States

🇺🇸

Massachusetts General Hospital Epilepsy Service - WACC, Boston, Massachusetts, United States

and more 100 locations
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