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

NCT00152373 | Completed Phase 3

• 1 other identifier: N01102
• Study Type: interventional
• Target: 192
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Epilepsy, Partial

Keywords

Epilepsy, Partial Onset Seizures; Keppra; Levetiracetam

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

• Seizure freedom ;

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

• Safety and tolerability

Interventions

Levetiracetam DRUG

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• UCB Pharma: lead

MeSH Terms

Conditions

Epilepsies, Partial; Epilepsy

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• UCB Clinical Trial Call Center

  UCB Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 9, 2005
• Study Start: July 1, 2004
• Primary Completion: May 1, 2005
• Study Completion: May 1, 2005
• Last Updated: December 3, 2013

Record last verified: 2009-09