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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT00988156
First received: October 1, 2009
Last updated: July 16, 2014
Last verified: May 2014

October 1, 2009
July 16, 2014
December 2007
August 2012   (final data collection date for primary outcome measure)
  • Change From Baseline in Seizure Frequency [ Time Frame: Baseline up to Visit 7 ] [ Designated as safety issue: No ]
    Relative reduction in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.
  • Responder Rate [ Time Frame: baseline up to Visit 7 ] [ Designated as safety issue: No ]
    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.
To assess the efficacy of Eslicarbazepine acetate as adjunctive therapy in children and adolescents with refractory partial seizures [ Time Frame: 34 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00988156 on ClinicalTrials.gov Archive Site
Not Provided
To assess the safety and tolerability of Eslicarbazepine acetate as adjunctive therapy in children and adolescents with refractory partial seizures [ Time Frame: 34 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children
Efficacy and Safety Study of Eslicarbazepine Acetate (BIA 2 093) as Adjunctive 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.

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
Interventional
Phase 3
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
  • Drug: Eslicarbazepine acetate (BIA 2-093)

    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 Name: BIA 2093
  • Drug: Eslicarbazepine acetate

    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 Name: BIA 2093
  • Active Comparator: Eslicarbazepine acetate
    To receive Eslicarbazepine acetate in addition to concomitant therapy
    Intervention: Drug: Eslicarbazepine acetate (BIA 2-093)
  • Placebo Comparator: Placebo
    To receive placebo in addition to concomitant therapy
    Intervention: Drug: Eslicarbazepine acetate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
304
October 2015
August 2012   (final data collection date for primary outcome measure)

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
Both
2 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Bosnia and Herzegovina,   Croatia,   Czech Republic,   France,   Germany,   Hungary,   Italy,   Malaysia,   Moldova, Republic of,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Slovakia,   Spain,   Taiwan,   Ukraine,   United Kingdom
 
NCT00988156
BIA-2093-305
No
Bial - Portela C S.A.
Bial - Portela C S.A.
Not Provided
Not Provided
Bial - Portela C S.A.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP