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

BIAL

Status and phase: Completed; Phase 3

Conditions: Partial Epilepsy in Children and Adolescents

Treatments: Drug: Eslicarbazepine acetate; Drug: Eslicarbazepine acetate (BIA 2-093)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00988156

BIA-2093-305

2007-001887-55 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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

Enrollment: 304 patients

Sex: All

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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304 participants in 2 patient groups, including a placebo group

Eslicarbazepine acetate

Active Comparator group

Description:

To receive Eslicarbazepine acetate in addition to concomitant therapy

Treatment:

Drug: Eslicarbazepine acetate (BIA 2-093)

Placebo

Placebo Comparator group

Description:

To receive placebo in addition to concomitant therapy

Treatment:

Drug: Eslicarbazepine acetate