Determine Effects of Adjunctive Levetiracetam on Sleep Architecture in Adults With Partial Onset Epilepsy.
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|ClinicalTrials.gov Identifier: NCT00245713|
Recruitment Status : Completed
First Posted : October 28, 2005
Last Update Posted : November 26, 2013
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy, Partial||Drug: levetiracetam||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||40 participants|
|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.|
|Study Start Date :||March 2003|
|Actual Primary Completion Date :||November 2004|
|Actual Study Completion Date :||November 2004|
- 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 endpoints are based on the changes from Baseline to visit 7
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00245713
|Study Director:||UCB Clinical Trial Call Center||UCB Pharma|