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Completed

NCT Number: NCT00152373

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

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

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Key information

Conditions

Epilepsy, Partial Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Nervous System Diseases

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • subject suffering from partial onset seizures, whether or not secondarily generalized,
  • 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.
  • subject on a stable dose of at least one and no more than two other concomitant antiepileptic drugs (AEDs).
  • subject who has been exposed to at least one classical AEDs,
  • 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

  • history of status epilepticus within three months prior to the Selection visit,
  • subjects whose seizures cannot reliably be counted on a regular basis due to their fast and repetitive occurrence (clusters or flurries),
  • 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.,
  • history or presence of pseudoseizures,

Treatment and study plan

Levetiracetam

Drug

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

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study 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.

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 9, 2005
Registry last updated
Dec 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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