At a glance
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Efficacy and Safety Study of Eslicarbazepine Acetate (BIA 2 093) as Adjunctive Therapy for Refractory Partial Seizures in Children
In Brief
A Phase 3 clinical trial evaluating Eslicarbazepine acetate (BIA 2-093) and Eslicarbazepine acetate for Partial Epilepsy in Children and Adolescents. Completed, enrolled 304 participants across 91 sites in 21 countries.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.