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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: Brivaracetam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brivaracetam<br> | Drug: Brivaracetam<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Trough Plasma Concentration at 3rd Level for Age Range ≥1 Month to <2 Years |  | Day 21 | 
| Mean Trough Plasma Concentration at 3rd Level for Age Range ≥2 to <12 Years |  | Day 21 | 
| Mean Trough Plasma Concentration at 3rd Level for Age Range ≥12 to <16 Years |  | Day 21 | 
| Mean Max Plasma Concentration for Age Range ≥1 Month to <2 Years |  | Day 21 | 
| Mean Max Plasma Concentration for Age Range ≥2 to <12 Years |  | Day 21 | 
| Mean Max Plasma Concentration for Age Range ≥12 to <16 Years |  | Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With at Least One Treatment-emergent Adverse Event Reported During the 3-week Evaluation Period |  | 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 |  | Baseline to end of the 3-week evaluation period | 
| Percent Compliance With Brivaracetam Oral Solution During the 3-week Evaluation Period |  | Baseline to the end of the 3-week evaluation period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brivaracetam, Epilepsy, Child, Pharmacokinetics, Adolescents