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Completed

NCT Number: NCT00988156

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 whose condition has not been controlled by other drug treatments.

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Key information

Conditions

Partial Epilepsy in Children and Adolescents Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ambulanz für Neuropädiatrie und Entwicklungsdiagnostik, Med. Univ. Graz, Graz, Austria

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • girls of child-bearing potential have to follow reliable and medically acceptable contraceptive method throughout the study
  • diagnosis of epilepsy for at least 6 months prior to enrolment
  • at least 4 partial-onset seizures in the last month prior to enrolment despite stable therapy with adequate dosage of 1 or 2 AEDs
  • at least 4 partial-onset seizures during each 4-week interval of the 8-week baseline period
  • previous treatment with three or more AEDs, in their maximum tolerated doses, for at least one month, without seizure control
  • current treatment with 1 or 2 AEDs (any except oxcarbazepine); if present, vagus nerve stimulation is considered an AED
  • stable dose regimen of AEDs during the 8-week baseline period
  • cooperation and willingness to complete all aspects of the study, including hospitalisation if required
  • written informed consent to participate in the study in accordance with local legislation

Exclusion criteria

  • primarily generalised seizures
  • baseline seizure frequency substantially different from usual seizure frequency
  • known progressive neurological disorders
  • history of status epilepticus within the 3 months prior to enrolment
  • seizures of non-epileptic origin
  • Lennon-Gastaut
  • West syndrome
  • Major psychiatric disorders
  • Previous treatment any study with Eslicarbazepine acetate

Treatment and study plan

Eslicarbazepine acetate (BIA 2-093)

Drug

Part I - 8-week observational baseline period followed by a 6-week double-blind titration period, a 12-week double-blind maintenance period, a double-blind tapering-off period, and a 4-week observational period.

The recommended target dose of double-blind study treatment will be 20mg/kg/day.

Part II: At the end of part I, there is an option to enter a long-term open-label extension period to receive Eslicarbazepine acetate for 1 year.

Other names: BIA 2093

eslicarbazepine acetate

Drug

Part I: 8-week observational baseline period followed by a 6-week double-blind titration period, a 12-week double-blind maintenance period, a double-blind tapering-off period, and a 4-week observational period.

Part II: At the end of part I, there is an option to enter a long-term open-label extension period to receive Eslicarbazepine acetate for 1 year.

Other names: BIA 2093

Primary outcomes

  1. Change From Baseline in Seizure Frequency

    Time frame: Baseline up to Visit 7

    Relative reduction in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.

  2. Responder Rate

    Time frame: baseline up to Visit 7

    Responder rate defined as the number of patients with at least a 50% decrease in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.

Sponsors and collaborators

Lead sponsor

Bial - Portela C S.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2017
First posted
Oct 2, 2009
Registry last updated
Nov 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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