Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children
Condition: Partial Epilepsy in Children and Adolescents
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Intervention: Eslicarbazepine acetate (BIA 2-093); Eslicarbazepine acetate
Intervention description: 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.; 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.
Intervention MeSH terms: Eslicarbazepine acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 304.0
Sex: All
Minimum age: 2 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Epilepsy; Partial; Refractory; Children; Adolescents; Adjunctive; Randomised; Double-blind; Placebo-controlled; Parallel-group

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.
    

Eligibility 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