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Efficacy and Safety of Eslicarbazepine Acetateas Monotherapy for Patients With Newly Diagnosed Partial-onset Seizures

2014-07-23 21:08:17 | BioPortfolio

Summary

The purpose of this study is to investigate the efficacy and safety of eslicarbazepine acetate (BIA 2-093) as monotherapy for patients with newly diagnosed partial-onset seizures.

Description

Epilepsy affects more than 50 million adults and children worldwide. Prevalence estimates in the total population vary from 4 to 8 per 1000 subjects. Anti-epileptic drugs (AEDs) are the major intervention and approximately 60% of newly diagnosed patients are seizure free on a single AED, but about 40% are not satisfactorily controlled and 25% suffer from significant adverse events (AEs). This lack of seizure control and unsatisfactory tolerability means there is still a need for new, effective AEDs that can be used as monotherapy.

Given the efficacy of ESL in controlling partial onset seizures, the good tolerability and the convenience of QD dosing instead of twice daily (BID) dosing, ESL could offer a beneficial alternative as a first-line therapy in patients newly diagnosed with epilepsy experiencing partial-onset seizures. This study aims to demonstrate the efficacy and safety of ESL as a monotherapy treatment for this patient population proving non-inferiority to a standard therapy, Carbamazepine controlled release (CBZ-CR).

Study Design

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

Conditions

Epilepsy

Intervention

Eslicarbazepine acetate (BIA 2-093)

Status

Not yet recruiting

Source

Bial - Portela C S.A.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:17-0400

Clinical Trials [751 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.

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

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...

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...

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...

PubMed Articles [1671 Associated PubMed Articles listed on BioPortfolio]

Effects of adjunctive eslicarbazepine acetate on serum lipids in patients with partial-onset seizures: Impact of concomitant statins and enzyme-inducing antiepileptic drugs.

To evaluate the effects of eslicarbazepine acetate (ESL) on lipid metabolism and to determine whether reduced statin exposure during ESL therapy has clinical consequences.

Effects of adjunctive eslicarbazepine acetate on neurocognitive functioning in children with refractory focal-onset seizures.

This was a phase-II, randomized, double-blind (DB), placebo-controlled study aimed to evaluate neurocognitive effects of eslicarbazepine acetate (ESL) as adjunctive therapy in pediatric patients with ...

Psychiatric and cognitive adverse events: A pooled analysis of three phase III trials of adjunctive eslicarbazepine acetate for partial-onset seizures.

To evaluate the nature and incidence of psychiatric and cognitive adverse events (AEs) reported with eslicarbazepine acetate (ESL) used as adjunctive treatment for refractory partial-onset seizures (P...

Comparing the dosages of lacosamide, eslicarbazepine acetate, and controlled-release carbamazepine in noninferiority epilepsy monotherapy trials: How much "fair" is "fair"?

Response: Comparing the dosages of lacosamide, eslicarbazepine acetate, and controlled-release carbamazepine in noninferiority epilepsy monotherapy trials: How much "fair" is "fair".

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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