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

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ClinicalTrials.gov Identifier: NCT00988156
Recruitment Status : Completed
First Posted : October 2, 2009
Results First Posted : July 17, 2014
Last Update Posted : November 13, 2018
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Study Description
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Brief 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.

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

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Actual Study Start Date : December 7, 2007
Actual Primary Completion Date : August 20, 2012
Actual Study Completion Date : August 24, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Layout table for eligibility information
Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00988156


Locations
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Sponsors and Collaborators
Bial - Portela C S.A.
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT00988156    
Other Study ID Numbers: BIA-2093-305
2007-001887-55 ( EudraCT Number )
First Posted: October 2, 2009    Key Record Dates
Results First Posted: July 17, 2014
Last Update Posted: November 13, 2018
Last Verified: October 2018
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:
Layout table for MeSH terms
Epilepsy
Seizures
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
 Eslicarbazepine acetate
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action