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Trial record 1 of 1 for:    NCT00245713
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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
Sponsor:
Information provided by:
UCB Pharma

Study Description
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Brief Summary:
Effect of adjunctive levetiracetam on polysomnography in adults with partial-onset epilepsy receiving a classical antiepileptic drug

Condition or disease Intervention/treatment Phase
Epilepsy, Partial Drug: levetiracetam Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Secondary endpoints are based on the changes from Baseline to visit 7

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

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


Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center UCB Pharma
More Information
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ClinicalTrials.gov Identifier: NCT00245713    
Other Study ID Numbers: N01085
First Posted: October 28, 2005    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: September 2009
Keywords provided by UCB Pharma:
Levetiracetam, adult, partial-onset epilepsy, antiepileptic
Additional relevant MeSH terms:
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Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Levetiracetam
Anticonvulsants
Nootropic Agents