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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00152373

Enrollment

192

Registered

2005-09-09

Start date

2004-07-31

Completion date

2005-05-31

Last updated

2013-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy, Partial

Keywords

Epilepsy, Partial Onset Seizures; Keppra; Levetiracetam

Brief summary

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

Interventions

DRUGLevetiracetam

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

16 Years to 70 Years

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,

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026