A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy

PHASE3CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

October 6, 2014

Primary Completion Date

April 30, 2020

Study Completion Date

April 30, 2020

Conditions
Epilepsy
Interventions
DRUG

Topiramate

Topiramate weight based dosing for participants 2 to \<10 years of age not to exceed 350 mg/day, as tolerated; not to exceed 400 mg/day in participants 10-15 years of age, as tolerated.

DRUG

Levetiracetam

Levetiracetam weight based dosing for all participants 2-15 years of age, not to exceed 60 mg/kg/day, as tolerated. The maximum recommended daily dosage is 3,000 mg.

Trial Locations (41)

Unknown

Birmingham

Los Angeles

Gulf Breeze

Orlando

Tampa

Wellington

Louisville

Columbus

Toledo

Portland

San Antonio

Temple

Buenos Aires

Córdoba

Queensland

Graz

Leuven

Namur

Saskatoon

Brest

Bron

Paris

Toulouse

München

Tübingen

Balassagyarmat

Budapest

Debrecen

Veszprém

Cebu

Manila

Krakow

Poznan

Warsaw

Saint Petersburg

Ulyanovsk

Durban

Kaohsiung City

New Taipei City

Taichung

Taipei

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02201251 - A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy | Biotech Hunter | Biotech Hunter