NCT00988156

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

Efficacy and Safety Study of Eslicarbazepine Acetate (BIA 2 093) as Adjunctive Therapy for Refractory Partial Seizures in Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 304 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 2 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Partial Epilepsy in Children and Adolescents

Interventions

Type	Name	Description
DRUG	Eslicarbazepine acetate (BIA 2-093)	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.
DRUG	Eslicarbazepine acetate	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.

Timeline

• Start date: 2007-12-07
• Primary completion: 2012-08-20
• Completion: 2017-08-24
• First posted: 2009-10-02
• Last updated: 2018-11-13
• Results posted: 2014-07-17

Locations

91 sites across 21 countries: Austria, Bosnia and Herzegovina, Croatia, Czechia, France, Germany, Hungary, Italy, Malaysia, Moldova, Philippines, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Spain, Taiwan, Ukraine, United Kingdom