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

NCT ID: NCT00245713

Last Updated: 2013-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2004-11-30

Brief Summary

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

Conditions

Epilepsy, Partial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Interventions

levetiracetam

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: lead

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

UCB Pharma

Other Identifiers

N01085

Identifier Type: -

Identifier Source: org_study_id