A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures

PHASE3CompletedINTERVENTIONAL
Enrollment

540

Participants

Timeline

Start Date

August 13, 2014

Primary Completion Date

April 13, 2022

Study Completion Date

April 13, 2022

Conditions
Epilepsy
Interventions
DRUG

Lacosamide

"Pharmaceutical form: oral solution~Concentration: 1 mg/kg - 6 mg/kg BID (2 mg/kg/day - 12 mg/ kg/day)~Route of administration: oral use"

DRUG

Lacosamide

"Pharmaceutical form: tablet~Concentration: 50 mg - 300 mg BID (100 mg/day - 600 mg/day)~Route of administration: oral use"

Trial Locations (141)

28203

Ep0034 102, Charlotte

32819

Ep0034 105, Orlando

33609

Ep0034 117, Tampa

75235

Ep0034 129, Dallas

78207

Ep0034 630, San Antonio

89052

Ep0034 115, Henderson

97477

Ep0034 640, Springfield

35233-1711

Ep0034 638, Birmingham

40536-0284

Ep0034 124, Lexington

03756

Ep0034 120, Lebanon

98105-0371

Ep0034 114, Seattle

Unknown

Ep0034 143, Ciudad Autonoma de Buenos AIRE

Ep0034 142, Córdoba

Ep0034 200, Melbourne

Ep0034 203, Parkville

Ep0034 205, South Brisbane

Ep0034 304, Brussels

Ep0034 158, Passo Fundo

Ep0034 150, São Paulo

Ep0034 154, São Paulo

Ep0034 310, Plovdiv

Ep0034 530, Beijing

Ep0034 535, Changchun

Ep0034 532, Chongqing

Ep0034 536, Nanchang

Ep0034 531, Shanghai

Ep0034 537, Shenzhen

Ep0034 171, Medellín

Ep0034 613, Osijek

Ep0034 610, Rijeka

Ep0034 612, Zagreb

Ep0034 321, Hradec Králové

Ep0034 320, Ostrava-poruba

Ep0034 323, Prague

Ep0034 322, Praha 4 - KRC

Ep0034 331, Tallinn

Ep0034 330, Tartu

Ep0034 346, Rennes

Ep0034 344, Strasbourg

Ep0034 620, Tbilisi

Ep0034 621, Tbilisi

Ep0034 622, Tbilisi

Ep0034 623, Tbilisi

Ep0034 542, Athens

Ep0034 361, Budapest

Ep0034 362, Budapest

Ep0034 363, Budapest

Ep0034 364, Budapest

Ep0034 368, Budapest

Ep0034 360, Debrecen

Ep0034 367, Miskolc

Ep0034 366, Pécs

Ep0034 374, Petah Tikva

Ep0034 397, Genova

Ep0034 380, Mantova

Ep0034 398, Messina

Ep0034 381, Milan

Ep0034 393, Padua

Ep0034 383, Roma

Ep0034 392, Roma

Ep0034 395, Roma

Ep0034 386, Verona

Ep0034 400, Riga

Ep0034 402, Valmiera

Ep0034 411, Kaunas

Ep0034 694, Aguascalientes

Ep0034 569, Culiacán

Ep0034 693, Culiacán

Ep0034 563, Guadalajara

Ep0034 564, México

Ep0034 568, Monterrey

Ep0034 650, Chisinau

Ep0034 660, Podgorica

Ep0034 724, Cebu

Ep0034 721, Manila

Ep0034 433, Gdansk

Ep0034 420, Kielce

Ep0034 422, Krakow

Ep0034 431, Krakow

Ep0034 423, Poznan

Ep0034 425, Poznan

Ep0034 429, Tyniec Mały

Ep0034 430, Warsaw

Ep0034 428, Wroclaw

Ep0034 750, Lisbon

Ep0034 574, Bucharest

Ep0034 581, Bucharest

Ep0034 572, Cluj-Napoca

Ep0034 582, Iași

Ep0034 573, Sibiu

Ep0034 576, Sibiu

Ep0034 580, Suceava

Ep0034 570, Timișoara

Ep0034 577, Timișoara

Ep0034 443, Kazan'

Ep0034 444, Kazan'

Ep0034 454, Kemerovo

Ep0034 442, Moscow

Ep0034 449, Moscow

Ep0034 456, Nizhny Novgorod

Ep0034 452, Novosibirsk

Ep0034 453, Omsk

Ep0034 455, Perm

Ep0034 441, Saint Petersburg

Ep0034 446, Saint Petersburg

Ep0034 440, Smolensk

Ep0034 730, Smolensk

Ep0034 458, Tomsk

Ep0034 447, Voronezh

Ep0034 450, Yekaterinburg

Ep0034 461, Belgrade

Ep0034 464, Belgrade

Ep0034 460, Kragujevac

Ep0034 462, Novi Sad

Ep0034 463, Novi Sad

Ep0034 470, Bardejov

Ep0034 472, Nové Zámky

Ep0034 670, Ljubljana

Ep0034 211, Daegu

Ep0034 210, Seoul

Ep0034 212, Seoul

Ep0034 213, Seoul

Ep0034 215, Seoul

Ep0034 220, Changhua

Ep0034 222, Taichung

Ep0034 224, Taipei

Ep0034 236, Bangkoknoi

Ep0034 235, Pathum Wan

Ep0034 230, Ratchathewi

Ep0034 232, Ratchathewi

Ep0034 231, Tha Muang

Ep0034 233, Tha Muang

Ep0034 602, Dnipro

Ep0034 609, Dnipro

Ep0034 681, Ivano-Frankivsk

Ep0034 600, Kiev

Ep0034 606, Kiev

Ep0034 682, Uzhhorod

Ep0034 603, Vinnytsia

Ep0034 515, Cambridge

Ep0034 511, Leeds

All Listed Sponsors
collaborator

UCB Biopharma SRL

INDUSTRY

lead

UCB BIOSCIENCES, Inc.

INDUSTRY

NCT01964560 - A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures | Biotech Hunter | Biotech Hunter