Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy

PHASE3CompletedINTERVENTIONAL
Enrollment

257

Participants

Timeline

Start Date

August 1, 2011

Primary Completion Date

February 3, 2022

Study Completion Date

February 3, 2022

Conditions
Epilepsy
Interventions
DRUG

Brivaracetam (BRV)

The max BRV dose will be 5.0 mg/kg/day, not to exceed a dose of 200 mg/day for subjects with body weight \>40kg. Subjects may receive oral solution or oral tablets. The LTFU subjects will start dosing in N01266 on the individualized BRV dose they were receiving at the completion of the core study. Subjects must be able to tolerate the min BRV dose specified in the core study to be eligible for entry into the Evaluation Period of N01266. Dose can be adjusted as considered necessary by the Investigator and required by the subject's medical condition. All subjects who prematurely discontinue the study should complete an EDV and have their BRV dose down titrated by a maximum of half the dose every week for a maximum of 4 weeks until a dose of 1 mg/kg/day (50 mg/day for subjects with body weights \>50kg) is reached.

Trial Locations (56)

10029

N01266 252, New York

14222

N01266 105, Buffalo

14642

N01266 104, Rochester

15201

N01266 114, Pittsburgh

27710

N01266 237, Durham

32561

N01266 108, Gulf Breeze

33470

N01266 103, Wellington

43205

N01266 111, Columbus

45229

N01266 107, Cincinnati

55102

N01266 101, Saint Paul

60611

N01266 118, Chicago

63017

N01266 113, Chesterfield

77030

N01266 117, Houston

90027

N01266 243, Los Angeles

02111

N01266 106, Boston

Unknown

N01266 202, Brussels

N01266 203, Brussels

N01266 201, Leuven

N01266 204, Leuven

N01266 502, Hradec Králové

N01266 504, Ostrava Prouba

N01266 240, Prague

N01266 207, Lille

N01266 206, Paris

N01266 218, Bayern

N01266 209, Freiburg im Breisgau

N01266 210, Budapest

N01266 224, Budapest

N01266 247, Budapest

N01266 222, Debrecen

N01266 232, Miskolc

N01266 211, Cork

N01266 212, Messina

N01266 213, Parma

N01266 238, Pavia

N01266 239, Pavia

N01266 230, Roma

N01266 256, Roma

N01266 223, Aguascalientes

N01266 611, Chihuahua City

N01266 609, Culiacán

N01266 603, Guadalajara

N01266 610, Monterrey

N01266 404, Bialystok

N01266 403, Gdansk

N01266 406, Kielce

N01266 402, Krakow

N01266 401, Poznan

N01266 407, Szczecin

N01266 405, Wroclaw

N01266 309, Barcelona

N01266 306, Madrid

N01266 301, Palma de Mallorca

N01266 248, Seville

N01266 308, Valencia

N01266 215, London

All Listed Sponsors
lead

UCB Pharma SA

INDUSTRY

NCT01364597 - Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy | Biotech Hunter | Biotech Hunter