Determine Effects of Adjunctive Levetiracetam on Sleep Architecture in Adults With Partial Onset Epilepsy.
This study has been completed.
Information provided by:
First received: October 26, 2005
Last updated: September 14, 2009
Last verified: September 2009
Effect of adjunctive levetiracetam on polysomnography in adults with partial-onset epilepsy receiving a classical antiepileptic drug
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
|Official Title:||9-11 Week Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Study to Determine Effects of Adjunctive Levetiracetam on Sleep Architecture of Adults With Partial Onset Epilepsy Receiving a First Generation Anti-epileptic Drug.|
Resource links provided by NLM:
Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsyU.S. FDA Resources
Further study details as provided by UCB, Inc.:
Primary Outcome Measures:
- Changes from Baseline to visit 7 in percent REM, percent slow wave sleep (stages 3 and 4), and sleep efficiency (which is total sleep time ÷ time in bed defined as lights out), with particular focus on sleep efficiency.
Secondary Outcome Measures:
- Secondary endpoints are based on the changes from Baseline to visit 7
|Study Start Date:||March 2003|
|Study Completion Date:||November 2004|
|Primary Completion Date:||November 2004 (Final data collection date for primary outcome measure)|
Contacts and Locations