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

2014-08-26 22:18:57 | BioPortfolio


The purpose of this study is to examine the efficacy and safety of Eslicarbazepine acetate (BIA 2-093) when given with other anti-epileptic drugs to treat children with partial seizures whose condition has not been controlled by other drug treatments.


Partial epilepsy, the commonest form of epilepsy, is a difficult condition to treat with many patients continuing to have symptoms despite trying several medications. Lack of efficacy and adverse effects are commonly associated with current anti-epileptic drugs.

This study will examine the efficacy in addition to safety and tolerability of a new anti-epileptic drug, Eslicarbazepine acetate (BIA 2-093), as an adjunctive therapy for refractory partial seizures in children.

The primary analysis variables are:

- The responder rate (the proportion of patients with at least a 50% reduction in standardised seizure frequency)

- The relative reduction in standardised seizure frequency

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Partial Epilepsy in Children and Adolescents


Eslicarbazepine acetate (BIA 2-093), Eslicarbazepine acetate


Universitätsklinik für Kinder- und Jugendheilkunde, Klinische Abteilung für allg. Pädiatrie, AKH Wien




Bial - Portela C S.A.

Results (where available)

View Results


Published on BioPortfolio: 2014-08-26T22:18:57-0400

Clinical Trials [1576 Associated Clinical Trials listed on BioPortfolio]

Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures

The purpose of this study is to determine whether Eslicarbazepine acetate (BIA 2-093)is an effective adjunct therapy in the treatment of refractory partial seizures

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

This is an 18-week, double-blind, multicenter study with gradual conversion from previous antiepileptic therapy to eslicarbazepine acetate monotherapy in subjects with partial epilepsy.

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

This purpose of this study is to measure the concentrations of two anti-epileptic drugs (Eslicarbazepine acetate and oxcarbazepine) and their metabolites in the cerebrospinal fluid and blo...

Eslicarbazepine Acetate Monotherapy Long Term Study

This is a one-year, open label, safety extension study in subjects with partial onset seizures.

Effect of Repeat Administration of Eslicarbazepine Acetate on the Pharmacokinetics of a Combined Oral Contraceptive

The purpose of this study is to investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics and tolera...

PubMed Articles [10532 Associated PubMed Articles listed on BioPortfolio]

Efficacy and safety of conversion to monotherapy with eslicarbazepine acetate in adults with uncontrolled partial-onset seizures: a historical-control phase III study.

Eslicarbazepine acetate (ESL, Aptiom®) is a once-daily (QD) anticonvulsant, approved as adjunctive treatment of partial-onset seizures (POS). It is extensively converted after oral administration to ...

A review of the efficacy and safety of eslicarbazepine acetate in the management of partial-onset seizures.

Eslicarbazepine acetate is a is a once-daily antiepileptic drug (AED) that was approved in 2009 by the European Medicines Agency (EMA) (Zebinix™), and in 2013 by the US Food and Drug Administration ...

Efficacy and safety of conversion to monotherapy with eslicarbazepine acetate in adults with uncontrolled partial-onset seizures: A randomized historical-control phase III study based in North America.

To assess the efficacy and safety of eslicarbazepine acetate (ESL) as monotherapy in North American patients with partial-onset seizures (POS).

Experience with eslicarbazepine acetate as treatment for painful diabetic neuropathy.

Clinical and neuropsychological assessment of attention and ADHD comorbidity in a sample of children and adolescents with idiopathic epilepsy.

Children with epilepsy present significant problems concerning attention and comorbidity with attention deficit hyperactivity disorder (ADHD). Objective To determine the prevalence of attention compla...

Medical and Biotech [MESH] Definitions

An enzyme that catalyzes the conversion of acetate esters and water to alcohols and acetate. EC

Megestrol acetate is a progestogen with actions and uses similar to those of the progestogens in general. It also has anti-androgenic properties. It is given by mouth in the palliative treatment or as an adjunct to other therapy in endometrial carcinoma and in breast cancer. Megestrol acetate has been approved to treat anorexia and cachexia. (From Reynolds JEF(Ed): Martindale: The Extra Pharmacopoeia (electronic version). Micromedex, Inc, Englewood, CO, 1995)

A 6-methyl PROGESTERONE acetate with reported glucocorticoid activity and effect on ESTRUS.

An enzyme that catalyzes the formation of CoA derivatives from ATP, acetate, and CoA to form AMP, pyrophosphate, and acetyl CoA. It acts also on propionates and acrylates. EC

An enzyme that catalyzes reversibly the phosphorylation of acetate in the presence of a divalent cation and ATP with the formation of acetylphosphate and ADP. It is important in the glycolysis process. EC

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