Determine Effects of Adjunctive Levetiracetam on Sleep Architecture in Adults With Partial Onset Epilepsy.
Phase 4
Completed
- Conditions
- Epilepsy, Partial
- Registration Number
- NCT00245713
- Lead Sponsor
- UCB Pharma
- Brief Summary
Effect of adjunctive levetiracetam on polysomnography in adults with partial-onset epilepsy receiving a classical antiepileptic drug
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Subjects must have partial onset epilepsy and have been taking carbamazepine or phenytoin at a stable dose for a period of 4 weeks prior to the selection visit
- Subjects must have controlled partial onset seizures which can potentially benefit from adjunctive treatment
Exclusion Criteria
- Subjects dosing with LEV two weeks prior to the selection visit
- Subjects using more than one AED
- Subjects with specific and non-specific sleep disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method Secondary endpoints are based on the changes from Baseline to visit 7