Bridging Study of L059 (Levetiracetam) in Patients With Epilepsy by Double Blind Method
This study has been completed.
UCB Japan Co. Ltd.
Information provided by:
First received: January 14, 2008
Last updated: September 9, 2009
Last verified: September 2009
Double-blind, randomized, placebo-controlled, multi center trial to evaluate the efficacy and safety of levetiracetam as adjunctive treatment in adult Japanese epileptic subjects with partial onset seizures.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Bridging Study of L059(Levetiracetam) in Patients With Epilepsy by Double Blind Method|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by UCB, Inc.:
Primary Outcome Measures:
- partial onset seizure frequency per week [ Time Frame: collection of seizure count throughout the whole study (baseline and treatment periods) ]
Secondary Outcome Measures:
- safety and tolerability [ Time Frame: safety and tolerability data were collected throughout the study period ]
|Study Start Date:||January 2001|
|Study Completion Date:||July 2003|
|Primary Completion Date:||July 2003 (Final data collection date for primary outcome measure)|
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