NCT01921205 - Study to Investigate Lacosamide as Add-on Therapy in Subjects ≥4 Years to <17 Years of Age With Partial Onset Seizures | Biotech Hunter

Enrollment

404

Participants

Timeline

Start Date

August 29, 2013

Primary Completion Date

January 24, 2017

Study Completion Date

January 24, 2017

Conditions

Epilepsy

Interventions

DRUG

Lacosamide

"Subjects \<30 kg (LCM oral solution): 4 mg/kg - 6 mg/kg BID ( 8mg/kg/day - 12 mg/kg/day)~Subjects ≥30 kg to \<50 kg (LCM oral solution): 3 mg/kg - 4 mg/kg BID (6 mg/kg/day - 8 mg/kg/day)~Subjects ≥50 kg (LCM tablets): 150 mg - 200 mg BID (300 mg/day - 400 mg/day)"

OTHER

Placebo

"Subjects \<30 kg (placebo oral solution): 4 mg/kg - 6 mg/kg BID (8 mg/kg/day - 12 mg/kg/day)~Subjects ≥30 kg to \<50 kg (placebo oral solution): 3 mg/kg - 4 mg/kg BID (6 mg/kg/day - 8 mg/kg/day)~Subjects ≥50 kg (placebo tablets): 150 mg - 200 mg BID (300 mg/day - 400 mg/day)"

Trial Locations (118)

Unknown

127, Boulder

105, Orlando

117, Tampa

103, Atlanta

124, Lexington

112, Louisville

121, Shreveport

115, Las Vegas

102, Charlotte

640, Eugene

122, Dallas

101, Tomball

114, Seattle

143, Buenos Aires

142, Córdoba

200, Heidelberg West

203, Herston

205, South Brisbane

304, Brussels

310, Sofia

312, Sofia

172, Floridablanca

171, Medellín

613, Osijek

610, Rijeka

612, Zagreb

321, Hradec Králové

320, Ostrava-Poruba

322, Prague

323, Prague

331, Tallinn

330, Tartu

620, Tbilisi

621, Tbilisi

622, Tbilisi

623, Tbilisi

361, Budapest

362, Budapest

363, Budapest

364, Budapest

360, Debrecen

367, Miskolc

366, Pécs

370, Holon

371, Kfar Saba

374, Petah Tikva

372, Tel Aviv

384, Bologna

388, Florence

387, Genova

380, Mantova

381, Milan

393, Padua

383, Roma

392, Roma

386, Verona

400, Riga

402, Valmiera

411, Kaunas

569, Culiacán

563, Guadalajara

568, Monterrey

660, Podgorica

433, Gdansk

432, Katowice

420, Kielce

422, Krakow

431, Krakow

423, Poznan

425, Poznan

421, Szczecin

429, Tyniec Mały

430, Warsaw

428, Wroclaw

574, Bucharest

572, Cluj-Napoca

576, Sibiu

580, Suceava

570, Timișoara

577, Timișoara

443, Kazan'

444, Kazan'

442, Moscow

449, Moscow

441, Saint Petersburg

446, Saint Petersburg

440, Smolensk

447, Voronezh

464, Belgrade

460, Kragujevac

461, New Belgrade

462, Novi Sad

463, Novi Sad

470, Bardejov

473, Nitra

472, Nové Zámky

670, Ljubljana

211, Daegu

210, Seoul

212, Seoul

213, Seoul

215, Seoul

220, Changhua

222, Taichung

224, Taipei

232, Bangkok

236, Bangkoknoi

231, Muang

233, Muang

235, Pathumwan

230, Ratchathewi

602, Dnipropetrovsk

606, Kiev

682, Uzhhorod

603, Vinnitsa

514, Birmingham

515, Birmingham

511, Leeds