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

UCB Pharma40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Epilepsy, Partial

Interventions

levetiracetamDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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