Loading clinical trials...
Loading clinical trials...
An Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of Adjunctive Treatment With Levetiracetam in Japanese Patients (≥4 to <16 Years) With Uncontrolled Generalized Tonic-clonic (GTC) Seizures Despite Treatment With 1 or 2 Antiepileptic Drug(s)
To evaluate the efficacy and safety of Levetiracetam dry syrup at doses up to 60 mg/kg/day or 3000 mg/day used as adjunctive therapy in Japanese pediatric patients aged ≥4 to \<16 years with uncontrolled Generalized Tonic-Clonic (GTC) seizures despite treatment with 1 or 2 Anti-Epileptic Drugs (AEDs).
Age
4 - 15 years
Sex
ALL
Healthy Volunteers
No
191
Akita, Japan
184
Bunkyō City, Japan
309
Bunkyō City, Japan
107
Gifu, Japan
303
Hiroshima, Japan
108
Kobe, Japan
302
Kodaira, Japan
306
Kōshi, Japan
136
Moriyama, Japan
305
Nagoya, Japan
Start Date
February 1, 2011
Primary Completion Date
June 1, 2013
Completion Date
June 1, 2013
Last Updated
May 15, 2015
13
ACTUAL participants
Levetiracetam
DRUG
Lead Sponsor
UCB Japan Co. Ltd.
NCT06700356
NCT05667142
NCT02531880
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions