Determine Effects of Adjunctive Levetiracetam on Sleep Architecture in Adults With Partial Onset Epilepsy. - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00245713

Purpose

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

Condition	Intervention	Phase
Epilepsy, Partial	Drug: levetiracetam	Phase IV

MedlinePlus related topics: Epilepsy

Drug Information available for: Levetiracetam

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, 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.

Further study details as provided by UCB:

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:

Estimated Enrollment:	40
Study Start Date:	March 2003
Study Completion Date:	November 2004
Primary Completion Date:	November 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both

Criteria

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245713

Sponsors and Collaborators

UCB

Investigators

Study Director:

Suzan Leake

UCB

More Information

Study ID Numbers:	N01085
Study First Received:	October 26, 2005
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00245713
Health Authority:	United States: Food and Drug Administration

Keywords provided by UCB:

Levetiracetam, adult, partial-onset epilepsy, antiepileptic

Study placed in the following topic categories:

Epilepsies, Partial
Epilepsy
Piracetam

Central Nervous System Diseases
Etiracetam
Brain Diseases

Additional relevant MeSH terms:

Nootropic Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Protective Agents

Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009