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

PHASE2CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

March 31, 2013

Study Completion Date

March 31, 2013

Conditions
Epilepsy
Interventions
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"

Trial Locations (39)

Unknown

108, Gulf Breeze

110, Miami

103, Wellington

106, Boston

101, Saint Paul

113, Chesterfield

105, Buffalo

104, Rochester

107, Cincinnati

114, Pittsburgh

109, Nashville

117, Houston

202, Brussels

203, Brussels

201, Leuven

502, Hradec Králové

504, Ostrava Porubo

501, Prague

602, Aguascalientes

611, Chihuahua City

609, Ciuliacan

603, Guadalajara

604, Mexico City

610, Monterrey

607, San Luis Potosí City

404, Bialystok

403, Gdansk

406, Kielce

402, Krakow

401, Poznan

408, Rzeszów

407, Szczecin

405, Wroclaw

309, Barcelona

306, Madrid

301, Palma de Mallorca

304, Santander

308, Valencia

303, Zaragoza

Sponsors

Lead Sponsor

All Listed Sponsors
lead

UCB Pharma

INDUSTRY

NCT00422422 - Open-label, Pharmacokinetic, Safety and Efficacy Study of Adjunctive Brivaracetam in Children With Epilepsy. | Biotech Hunter | Biotech Hunter