NCT02170064

Pharmacokinetics, Efficacy and Tolerability of BIA 2-093

Pharmacokinetics, Efficacy and Tolerability of BIA 2-093 in Children and Adolescents With Refractory Partial Epilepsy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to characterize the pharmacokinetics of Eslicarbazepine acetate in children and adolescents with epilepsy.

Detailed description

This clinical study was planned to be performed as an open-label, single-centre, multiple-dose study, in 30 paediatric epileptic patients distributed by 3 age groups of 10 patients each: 2-6 years \[Group 1\], 7-11 years \[Group 2\], and 12-17 years \[Group 3\]. The study was constituted by a 4-week baseline phase, followed by 3 consecutive 4-week treatment periods with Eslicarbazepine acetate in which patients received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day (weeks 1-4), 15 mg/kg/day (weeks 5-8) and 30 mg/kg/day or 1800 mg/day, whichever less (weeks 9-12). At the end of each 4-week treatment period, patients were hospitalised and serial blood samples for drug assays were obtained over a dosing interval. After the last treatment period or in the event of premature discontinuation, the dose had to be down-titrated during a 2-week period. After the last treatment period patient could continue receiving Eslicarbazepine acetate ("compassionate use") if both parent(s)/guardian(s) /patient and his/her physician agreed this was in the best patient's interest. A follow-up visit occurred approximately 4 weeks after the last hospitalisation or early discontinuation.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	BIA 2-093 (Eslicarbazepine acetate)	Eslicarbazepine acetate administered at increasing daily doses of 5 mg/kg, 15 mg/kg, and 30 mg/kg (or 1800 mg, whichever less); once-daily; oral route

Timeline

• Start date: 2005-06-01
• Primary completion: 2006-04-01
• Completion: 2006-04-01
• First posted: 2014-06-23
• Last updated: 2017-09-20
• Results posted: 2014-09-01

Locations

1 site across 1 country: Romania