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

2014-08-27 03:18:57 | BioPortfolio

Summary

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.

Description

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

Conditions

Partial Epilepsy in Children and Adolescents

Intervention

Eslicarbazepine acetate (BIA 2-093), Eslicarbazepine acetate

Location

Universitätsklinik für Kinder- und Jugendheilkunde, Klinische Abteilung für allg. Pädiatrie, AKH Wien
Vienna
Austria
1090

Status

Recruiting

Source

Bial - Portela C S.A.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:57-0400

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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

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PubMed Articles [10773 Associated PubMed Articles listed on BioPortfolio]

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 ...

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Social, cultural, psychological and many other factors significantly impact the lives of epileptic children and their families. Parental concerns towards their children are less known in south Asian c...

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Endometriosis affects over 10 million women in the United States. Depot leuprolide acetate (LA), a gonadotropin-releasing hormone agonist, has been used extensively for the treatment of women with end...

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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