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

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.

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

Study Overview

• Status: Completed
• Conditions: Epilepsy, Partial
• Intervention / Treatment: Drug: Levetiracetam

• Study Type: Interventional
• Enrollment: 192
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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,

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Safety and tolerability
Seizure freedom ;
The partial onset (type I) seizure reduction response rate ;

Collaborators and Investigators

• Sponsor: UCB Pharma

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Actual): May 1, 2005
• Study Completion (Actual): May 1, 2005

Study Registration Dates

• First Submitted: September 7, 2005
• First Submitted That Met QC Criteria: September 7, 2005
• First Posted (Estimate): September 9, 2005

Study Record Updates

• Last Update Posted (Estimate): December 3, 2013
• Last Update Submitted That Met QC Criteria: December 2, 2013
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Epilepsy, Partial Onset Seizures; Keppra; Levetiracetam
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Epilepsies, Partial; Anticonvulsants; Nootropic Agents; Levetiracetam
• Other Study ID Numbers: N01102