NCT00422422

Open-label, Pharmacokinetic, Safety and Efficacy Study of Adjunctive Brivaracetam in Children With Epilepsy.

Open-Label, Single-Arm, Multicenter, Pharmacokinetic, Safety, and Efficacy Study of Adjunctive Administration of Brivaracetam in Subjects From ≥1 Month to <16 Years Old With Epilepsy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 1 Month – 16 Years
• Healthy volunteers: Not accepted

Summary

Initial study in children with epilepsy to evaluate the pharmacokinetics, safety, tolerability and preliminary efficacy of adjunctive treatment with brivaracetam, and to develop dosing adaptations for future studies.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Brivaracetam	Oral solution Evaluation period (3 weeks up-titration): For subjects ≥8 years: * \~0.4 mg/kg bid for Week 1 * \~0.8 mg/kg bid for Week 2 * \~1.6 mg/kg bid for Week 3 For subjects \<8 years: * \~0.5 mg/kg bid for Week 1 * \~1.0 mg/kg bid for Week 2 * \~2.0 mg/kg bid for Week 3 Down-titration period (up to 2 weeks): For subjects ≥8 years: * \~0.8 mg/kg bid for Week 4 * \~0.4 mg/kg bid for Week 5 For subjects \<8 years: * \~1.0 mg/kg bid for Week 4 * \~0.5 mg/kg bid for Week 5

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2007-01-17
• Last updated: 2018-07-11
• Results posted: 2017-01-09

Locations

39 sites across 6 countries: United States, Belgium, Czechia, Mexico, Poland, Spain