Conditions: Epilepsy
Keywords: Brivaracetam Epilepsy Child Pharmacokinetics Adolescents
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 100
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Brivaracetam
Intervention descriptions: intervention 1: 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

Protocol document: