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

UCB Pharma100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Epilepsy

Interventions

BrivaracetamDRUG

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

Eligibility

Sex: ALLMin age: 1 MonthMax age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of epilepsy * Subject having at least 1 seizure (any type) during the 3 weeks before first visit * Stable dosing of 1-3 concomitant antiepileptic drugs Exclusion Criteria: * Pregnant or nursing females * Concomitant use of Levetiracetam * Epilepsy secondary to a Progressive cerebral disease/tumor or other neurodegenerative disease * History of status epilepticus * Clinically significant acute or chronic illness, underlying disease or medication condition * History of suicide attempt

Locations (39)

108

Gulf Breeze, Florida, United States

Outcomes

Primary Outcomes

Mean Trough Plasma Concentration at 3rd Level for Age Range ≥1 Month to <2 Years

Time frame: Day 21

Mean Trough Plasma Concentration at 3rd Level for Age Range ≥2 to <12 Years

Time frame: Day 21

Mean Trough Plasma Concentration at 3rd Level for Age Range ≥12 to <16 Years

Time frame: Day 21

Mean Max Plasma Concentration for Age Range ≥1 Month to <2 Years

Time frame: Day 21

Mean Max Plasma Concentration for Age Range ≥2 to <12 Years

Time frame: Day 21

Mean Max Plasma Concentration for Age Range ≥12 to <16 Years

Time frame: Day 21

Secondary Outcomes

Number of Subjects With at Least One Treatment-emergent Adverse Event Reported During the 3-week Evaluation Period

Time frame: Baseline to end of the 3-week evaluation period

Number of Subjects With a 50 % Reduction in Seizures Based on Seizure Diary Data From Baseline to End of the 3-week Evaluation Period

Time frame: Baseline to end of the 3-week evaluation period

Percent Compliance With Brivaracetam Oral Solution During the 3-week Evaluation Period

Time frame: Baseline to the end of the 3-week evaluation period

Data from ClinicalTrials.gov

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