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
  Purpose

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.


Condition Intervention Phase
Partial Epilepsy in Children and Adolescents
Drug: Eslicarbazepine acetate (BIA 2-093)
Drug: Eslicarbazepine acetate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Study of Eslicarbazepine Acetate (BIA 2 093) as Adjunctive Therapy for Refractory Partial Seizures in Children

Resource links provided by NLM:


Further study details as provided by Bial - Portela C S.A.:

Primary Outcome Measures:
  • 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.


Enrollment: 304
Study Start Date: December 2007
Estimated Study Completion Date: October 2015
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Eslicarbazepine acetate
To receive Eslicarbazepine acetate in addition to concomitant therapy
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
Placebo Comparator: Placebo
To receive placebo in addition to concomitant therapy
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

Detailed 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
  Eligibility

Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988156

  Show 91 Study Locations
Sponsors and Collaborators
Bial - Portela C S.A.
  More Information

No publications provided

Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT00988156     History of Changes
Other Study ID Numbers: BIA-2093-305
Study First Received: October 1, 2009
Results First Received: May 9, 2014
Last Updated: July 16, 2014
Health Authority: Portugal: National Pharmacy and Medicines Institute

Keywords provided by Bial - Portela C S.A.:
Epilepsy
Partial
Refractory
Children
Adolescents
Adjunctive
Randomised
Double-blind
Placebo-controlled
Parallel-group

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 24, 2014