NCT00245713

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2005

Completed
Last Updated

November 26, 2013

Status Verified

September 1, 2009

Enrollment Period

1.7 years

First QC Date

October 26, 2005

Last Update Submit

November 25, 2013

Conditions

Epilepsy, Partial

Keywords

Levetiracetam, adult, partial-onset epilepsy, antiepileptic

Outcome Measures

Primary Outcomes (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 Outcomes (1)

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

Interventions

levetiracetamDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Epilepsies, Partial

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • UCB Clinical Trial Call Center

    UCB Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 26, 2005

First Posted

October 28, 2005

Study Start

March 1, 2003

Primary Completion

November 1, 2004

Study Completion

November 1, 2004

Last Updated

November 26, 2013

Record last verified: 2009-09