Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older

PHASE3CompletedINTERVENTIONAL
Enrollment

551

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

January 31, 2017

Study Completion Date

January 31, 2017

Conditions
EpilepsyMonotherapy
Interventions
DRUG

Lacosamide

50 and 100 mg tablets of Lacosamide given as 100 mg/day, 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years)

DRUG

Carbamazepine-Controlled Release (CBZ-CR)

200 mg tablets of Carbamazepine-CR given as 200 mg/day, 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum 3.5 Years)

Trial Locations (150)

Unknown

786, Alabaster

799, Huntsville

777, Little Rock

789, Panama City

776, Port Charlotte

873, Raleigh

794, Oklahoma City

881, Mansfield

790, Madison

104, Chatswood

105, Clayton

106, East Gosford

101, Fitzroy

108, Heidelberg

103, Herston

109, Randwick

127, Bruges

134, Bruges

128, Hasselt

126, Leuven

805, Blagoevgrad

807, Panagyurishte

803, Pleven

810, Rousse

811, Sofia

809, Veliko Tarnovo

152, Greenfield Park

158, Halifax Nova Scotia

156, Hamilton

153, St. John's

185, Brno

190, Ostrava - Vitkovice

184, Prague

189, Prague

180, Zlín

205, Helsinki

207, Kuopio

236, Nancy

263, Altenburg

265, Bad Neustadt an der Saale

257, Berlin

262, Berlin

270, Berlin

260, Göttingen

269, Leipzig

256, Marburg

259, Osnabrück

495, Ioannina

490, Thessalonikis

493, Thessalonikis

289, Balassagyarmat

283, Budapest

284, Budapest

286, Debrecen

282, Győr

285, Szeged

290, Szekszárd

291, Szombathely

310, Bari

309, Modena

308, Padua

314, Prato

311, Roma

831, Asaka-shi

833, Hamamatsu

834, Kagoshima

844, Kamakura-shi

843, Miyazaki

835, Nagoya

837, Okayama

828, Saitama-shi

847, Sapporo

832, Shizuoka

751, Riga

727, Alytus

724, Kaunas

728, Vilnius

547, San Luis Potosí City

673, Manila

672, Pasig

676, Quezon City

336, Gdansk

340, Katowice

342, Lublin

341, Poznan

338, Szczecin

343, Warsaw

360, Coimbra

362, Lisbon

365, Lisbon

366, Porto

361, Santa Maria da Feira

576, Bucharest

569, Cluj-Napoca

570, Iași

579, Iași

571, Sibiu

577, Sibiu

572, Târgu Mureş

387, Kazan'

389, Kazan'

396, Kirov

394, Moscow

401, Moscow

390, Nizhny Novgorod

392, Novosibirsk

397, Saint Petersburg

400, Saint Petersburg

386, Smolensk

399, Yaroslavl

594, Dolný Kubín

598, Dubnica nad Váhom

596, Hlohovec

600, Krompachy

595, Levoča

599, Tornaľa

601, Žilina

525, Busan

521, Daegu

518, Daejeon

517, Seoul

519, Seoul

520, Seoul

523, Seoul

524, Seoul

422, Badalona

413, Barcelona

417, Girona

416, Madrid

425, Madrid

419, San Cristóbal de La Laguna

418, San Sebastián

414, Santiago de Compostela

424, Seville

440, Gothenburg

442, Linköping

438, Stockholm

651, Aarau

654, Biel

653, Lugano

699, Bangkok

702, Bangkok

698, Khon Kaen

622, Chernihiv

626, Kharkiv

621, Luhansk

625, Odesa

632, Simferopol

472, Glasgow

471, Stoke-on-Trent

All Listed Sponsors
collaborator

Eden Sarl

INDUSTRY

lead

UCB BIOSCIENCES GmbH

INDUSTRY

NCT01465997 - Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older | Biotech Hunter | Biotech Hunter