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Determine Effects of Adjunctive Levetiracetam on Sleep Architecture in Adults With Partial Onset Epilepsy.

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.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00245713
Enrollment
40
Registered
2005-10-28
Start date
2003-03-31
Completion date
2004-11-30
Last updated
2013-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy, Partial

Keywords

Levetiracetam, adult, partial-onset epilepsy, antiepileptic

Brief summary

Effect of adjunctive levetiracetam on polysomnography in adults with partial-onset epilepsy receiving a classical antiepileptic drug

Interventions

DRUGlevetiracetam

Sponsors

UCB Pharma
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondary endpoints are based on the changes from Baseline to visit 7—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026