Overview

This trial is active, not recruiting.

Condition partial epilepsy in children and adolescents
Treatments eslicarbazepine acetate (bia 2-093), eslicarbazepine acetate
Phase phase 3
Sponsor Bial - Portela C S.A.
Start date December 2007
End date August 2012
Trial size 304 participants
Trial identifier NCT00988156, BIA-2093-305

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
To receive Eslicarbazepine acetate in addition to concomitant therapy
eslicarbazepine acetate (bia 2-093) BIA 2093
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.
(Placebo Comparator)
To receive placebo in addition to concomitant therapy
eslicarbazepine acetate BIA 2093
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.

Primary Outcomes

Measure
Change From Baseline in Seizure Frequency
time frame: Baseline up to Visit 7
Responder Rate
time frame: baseline up to Visit 7

Eligibility Criteria

Male or female participants from 2 years up to 16 years old.

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

Additional Information

Official title Efficacy and Safety Study of Eslicarbazepine Acetate (BIA 2 093) as Adjunctive Therapy for Refractory Partial Seizures in Children
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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Bial - Portela C S.A..