Overview

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

Status:
Completed
Trial end date:
2017-08-24
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bial - Portela C S.A.
Treatments:
Eslicarbazepine acetate
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