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CompletedNCT00152373Updated Dec 3, 2013

Double-blind, Placebo-controlled Study of Levetiracetam in Adults With POS

A Phase 3 interventional study of Levetiracetam in Epilepsy, Partial, sponsored by UCB Pharma. Completed. Open to participants aged 16 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-12-03.

Sponsored by UCB Pharma · Phase 3 and Interventional

Phase
Phase 3
Study type
Interventional
Enrollment
192
Allocation
Randomized
Ages
16 Years to 70 Years
Sex
All
01

Study summary

clinical efficacy and safety of Levetiracetam as add-on therapy in adult Chinese subjects with partial seizures.

02

Conditions studied

  • Epilepsy, Partial

Keywords

  • Epilepsy, Partial Onset Seizures; Keppra; Levetiracetam
03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 192 is above the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

UCB Pharma is the lead sponsor of 238 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 70 Years
Sexes eligible
All

Inclusion criteria

  1. subject suffering from partial onset seizures, whether or not secondarily generalized,
  2. presence of the following during the eight weeks of the historical baseline period: at least eight partial seizures (type IA, IB or IC) with or without secondary generalization.
  3. subject on a stable dose of at least one and no more than two other concomitant antiepileptic drugs (AEDs).
  4. subject who has been exposed to at least one classical AEDs,
  5. CT scan or MRI performed within the last 2 years and free of neoplasia, progressive cerebral disease or any other progressively neurodegenerative disease.

Exclusion criteria

Exclusion Criteria:

  1. history of status epilepticus within three months prior to the Selection visit,
  2. subjects whose seizures cannot reliably be counted on a regular basis due to their fast and repetitive occurrence (clusters or flurries),
  3. use of any medication (other than the concomitant AED) that influences the central nervous system (CNS) unless on a stable regimen for at least 1 month prior to the Selection visit. Antidepressants (except amitriptyline, mianserin and fluoxetine), anxiolytics and hypnotics are allowed. Intermittent benzodiazepines are allowed as long as the frequency is not greater than one single administration per week for at least 3 months prior to the Selection visit. Neuroleptics and Traditional Chinese AEDs are not allowed.,
  4. history or presence of pseudoseizures,
05

Study design

Phase
Phase 3
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
192 participants

Interventions

  • DrugLevetiracetam
06

What researchers measure

Primary outcomes

  1. The partial onset (type I) seizure frequency reduction per week over the 16-week treatment period (titration and maintenance)

Secondary outcomes

  1. Seizure freedom ;

  2. The partial onset (type I) seizure reduction response rate ;

  3. Safety and tolerability

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00152373
Lead sponsor
UCB Pharma
First posted
Sep 9, 2005
Start date
Jul 2004
Primary completion
May 2005
Completion
May 2005
Last update
Dec 3, 2013

Study contacts

UCB Clinical Trial Call Center
study director · UCB Pharma
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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