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

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00152373
First received: September 7, 2005
Last updated: December 2, 2013
Last verified: September 2009
  Purpose

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


Condition Intervention Phase
Epilepsy, Partial
Drug: Levetiracetam
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

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

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

Estimated Enrollment: 192
Study Start Date: July 2004
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Criteria

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,
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152373

Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center UCB, Inc.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00152373     History of Changes
Other Study ID Numbers: N01102
Study First Received: September 7, 2005
Last Updated: December 2, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by UCB, Inc.:
Epilepsy, Partial Onset Seizures; Keppra; Levetiracetam

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 31, 2014