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