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

2014-08-27 03:18:53 | BioPortfolio

Summary

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

Description

The efficacy of Eslicarbazepine acetate (BIA 2-093)will be evaluated at doses of 800 mg and 1200 mg once daily over a 12-week maintenance period.

This is a 2-part study. Part I will follow a parallel-group, randomised, placebo-controlled design and will consist of an 8-week baseline period, followed by a double-blind 2-week titration period and a 12-week maintenance period. At the end of the 8-week baseline period, patients will be randomly assigned to one of three treatment groups in a 1:1:1 ratio: Placebo (Group 1; n=120), Eslicarbazepine acetate 800 mg QD (Group 2; n=120) and Eslicarbazepine acetate 1200 mg QD (Group 3; n=120).

Patients who complete Part I may enter a 1-year open-label extension (Part II) with Eslicarbazepine acetate, starting with a dose of 800 mg QD for one month. Thereafter, investigators can titrate the dose upwards or downwards.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Partial Epilepsy

Intervention

Eslicarbazepine acetate, Eslicarbazepine acetate, Eslicarbazepine acetate

Location

University of South Alabama Department of Neurology
Mobile
Alabama
United States
36693

Status

Recruiting

Source

Bial - Portela C S.A.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:53-0400

Clinical Trials [1421 Associated Clinical Trials listed on BioPortfolio]

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.

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

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 wh...

Bioequivalence of Two Different Sources of Eslicarbazepine Acetate

The purpose of this study is to determine whether the test product, eslicarbazepine acetate 800 mg tablets (test 1, To be marketed (TBM) Treatment A), and the reference product, eslicarbaz...

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.

PubMed Articles [3523 Associated PubMed Articles listed on BioPortfolio]

Tolerability of adjunctive eslicarbazepine acetate according to concomitant lamotrigine or carbamazepine use: A subgroup analysis of three phase III trials in adults with focal (partial-onset) seizures.

To evaluate and compare the effects of concomitant lamotrigine (LTG) or carbamazepine (CBZ) on the incidence of treatment-emergent adverse events (TEAEs) in patients taking adjunctive eslicarbazepine ...

Eslicarbazepine acetate as monotherapy in clinical practice: outcomes from Euro-Esli.

To assess the effectiveness and safety/tolerability of eslicarbazepine acetate (ESL) monotherapy in clinical practice in Europe.

Formulation and Stability Study of Eslicarbazepine Acetate Oral Suspensions for Extemporaneous Compounding.

Eslicarbazepine acetate is an anticonvulsant drug with a recent U.S. Food and Drug Administration approval for expanded use in children and adolescents. Currently, eslicarbazepine acetate is only avai...

Modeling and simulations to support dose selection for eslicarbazepine acetate therapy in pediatric patients with partial-onset seizures.

Modeling and simulations were used to support body weight-based dose selection for eslicarbazepine acetate (ESL) in pediatric subjects aged 4-17 years with partial-onset seizures. A one-compartment p...

Sudden unexpected death in epilepsy in a patient with a cardiac pacemaker.

Epilepsy is a common neurologic disorder requiring continued treatment during pregnancy. Treatment with antiepileptic drugs (AEDs) is needed for seizure control, but the risk of adverse events has to ...

Medical and Biotech [MESH] Definitions

An enzyme that catalyzes the conversion of acetate esters and water to alcohols and acetate. EC 3.1.1.6.

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 6.2.1.1.

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 2.7.2.1.

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