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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00422422
• Other study ID #: N01263
• Secondary ID: 2006-006536-22
• Status: Completed
• Phase: Phase 2
• Start date: July 2011
• Est. completion date: March 2013

Study information

• Verified date: November 2016
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

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

Locations

Country	Name	City	State
Belgium	202	Brussels
Belgium	203	Brussels
Belgium	201	Leuven
Czechia	502	Hradec Kralove
Czechia	504	Ostrava Porubo
Czechia	501	Praha 4
Mexico	602	Aguascalientes
Mexico	611	Chihuahua
Mexico	609	Ciuliacan
Mexico	603	Guadalajara
Mexico	604	Mexico D.F.
Mexico	610	Monterrey
Mexico	607	San Luis Potosi
Poland	404	Bialystok
Poland	403	Gdansk
Poland	406	Kielce
Poland	402	Krakow
Poland	401	Poznan
Poland	408	Rzeszow
Poland	407	Szczecin
Poland	405	Wroclaw
Spain	309	Barcelona
Spain	306	Madrid
Spain	301	Palma de Mallorca
Spain	304	Santander
Spain	308	Valencia
Spain	303	Zaragoza
United States	106	Boston	Massachusetts
United States	105	Buffalo	New York
United States	113	Chesterfield	Missouri
United States	107	Cincinnati	Ohio
United States	108	Gulf Breeze	Florida
United States	117	Houston	Texas
United States	110	Miami	Florida
United States	109	Nashville	Tennessee
United States	114	Pittsburgh	Pennsylvania
United States	104	Rochester	New York
United States	101	Saint Paul	Minnesota
United States	103	Wellington	Florida

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

United States,  Belgium,  Czechia,  Mexico,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Trough Plasma Concentration at 3rd Level for Age Range =1 Month to <2 Years		Day 21
Primary	Mean Trough Plasma Concentration at 3rd Level for Age Range =2 to <12 Years		Day 21
Primary	Mean Trough Plasma Concentration at 3rd Level for Age Range =12 to <16 Years		Day 21
Primary	Mean Max Plasma Concentration for Age Range =1 Month to <2 Years		Day 21
Primary	Mean Max Plasma Concentration for Age Range =2 to <12 Years		Day 21
Primary	Mean Max Plasma Concentration for Age Range =12 to <16 Years		Day 21
Secondary	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
Secondary	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
Secondary	Percent Compliance With Brivaracetam Oral Solution During the 3-week Evaluation Period		Baseline to the end of the 3-week evaluation period