We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00152373
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00152373
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : December 3, 2013
Information provided by:
UCB Pharma

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

Condition or disease Intervention/treatment Phase
Epilepsy, Partial Drug: Levetiracetam Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: A Double-blind, Placebo-controlled, Randomized Study: 16-week Evaluation of the Efficacy and Safety of Levetiracetam (LEV) as add-on Therapy in Adults and Adolescents Older Than 16 Years Suffering From Partial Seizures.
Study Start Date : July 2004
Actual Primary Completion Date : May 2005
Actual Study Completion Date : May 2005

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

Secondary Outcome Measures :
  1. Seizure freedom ;
  2. The partial onset (type I) seizure reduction response rate ;
  3. Safety and tolerability

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   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:

  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,

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): NCT00152373

Sponsors and Collaborators
UCB Pharma
Layout table for investigator information
Study Director: UCB Clinical Trial Call Center UCB Pharma
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00152373    
Other Study ID Numbers: N01102
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: December 3, 2013
Last Verified: September 2009
Keywords provided by UCB Pharma:
Epilepsy, Partial Onset Seizures; Keppra; Levetiracetam
Additional relevant MeSH terms:
Layout table for MeSH terms
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Nootropic Agents