A Double-blind Study to Compare the Efficacy and Safety of Zonisamide and Carbamazepine as Monotherapy, in Newly Diagnosed Partial Epilepsy

PHASE3CompletedINTERVENTIONAL
Enrollment

583

Participants

Timeline

Start Date

May 31, 2007

Primary Completion Date

December 31, 2010

Study Completion Date

January 31, 2011

Conditions
Epilepsy
Interventions
DRUG

Zonisamide

Week 1 and 2 either 100mg zonisamide or 200 mg carbamazepine Week 3 and 4 either 200mg zonisamide or 4800 mg carbamazepine Week 5 and 6 either 300mg zonisamide or 600 mg carbamazepine; this dose then to be maintained unless a subject has a seizure more than two weeks post a dose increase.

DRUG

Carbamazepine

Week 1 and 2 either 100mg zonisamide or 200 mg carbamazepine Week 3 and 4 either 200mg zonisamide or 4800 mg carbamazepine Week 5 and 6 either 300mg zonisamide or 600 mg carbamazepine; this dose then to be maintained unless a subject has a seizure more than two weeks post a dose increase.

Trial Locations (79)

Unknown

Camperdown

Clayton

Fitzroy

Flinders

Heidelberg West

Parkville

Queensland

Wellington

Aalborg

Béthune

Dijon

Paris

Saint-Etienne

Berlin

Bochum

Düsseldorf

Munich

Schwerin

Westerstede

Athens

Thessaloniki

Budapest

Debrecen

Gyula

Hódmezővásárhely

Nyregyhaza

Zalaegerszeg-Pozva

Bangalore

Hyderabad

Koturpuram

Madurai

New Delhi

Pune

Milan

Monza

Orbassano

Rome

Gdansk

Katowice

Krakow

Lodz

Lublin

Poznan

Sosnowiec

Szcecin

Warsaw

Kaliningrad

Kazan'

Moscow

Saint Petersburg

Yaroslavl

Belgrade

Niš

Novi Sad

Subotica

Bratislava

Bratslava

Brezno

Nové Zámky

Vranov nad Topľou

Žilina

Sandton

Anyang

Seoul

Wŏnju

Alicante

Bacelona

Barcelona

Madrid

Málaga

Oviedo

Seville

Gothenburg

Lund

Changhua

Yongkang District

Bristol

Liverpool

Treliske

All Listed Sponsors
lead

Eisai Inc.

INDUSTRY

NCT00477295 - A Double-blind Study to Compare the Efficacy and Safety of Zonisamide and Carbamazepine as Monotherapy, in Newly Diagnosed Partial Epilepsy | Biotech Hunter | Biotech Hunter