Efficacy and Safety Study of Eslicarbazepine Acetate (BIA 2 093) as Adjunctive Therapy for Refractory Partial Seizures in Children
Overview
- Phase
- Phase 3
- Intervention
- Eslicarbazepine acetate (BIA 2-093)
- Conditions
- Partial Epilepsy in Children and Adolescents
- Sponsor
- Bial - Portela C S.A.
- Enrollment
- 304
- Locations
- 90
- Primary Endpoint
- Change From Baseline in Seizure Frequency
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
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
Investigators
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
Arms & Interventions
Eslicarbazepine acetate
To receive Eslicarbazepine acetate in addition to concomitant therapy
Intervention: Eslicarbazepine acetate (BIA 2-093)
Placebo
To receive placebo in addition to concomitant therapy
Intervention: Eslicarbazepine acetate
Outcomes
Primary Outcomes
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.
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.