Open Label Safety and Efficacy Study of Levetiracetam in Korean Patients With Epilepsy

A Korean Open-label, Multi-center, Community-based Trial Assessing the Efficacy and Safety of Levetiracetam as Adjunctive Therapy in Adult Subjects With Uncontrolled Partial Epilepsy for Bridging Purpose With a Similar Study on Caucasian Epileptic Subjects

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00160628

Enrollment

100

Registered

2005-09-12

Start date

2004-03-31

Completion date

2004-10-31

Last updated

2013-11-26

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

A Korean open-label, community-based trial assessing the efficacy and safety of levetiracetam as adjunctive therapy in partial epilepsy. Similarity with a similar study conducted in Caucasian epileptic subjects will be assessed.

Interventions

DRUGLevetiracetam

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

* Subjects with epilepsy experiencing partial seizures, whether or not secondarily generalized. * Subjects must present between 3 and 42 partial seizures over the three months prior to protocol Visit 1. * Use of one (1), but no more than two (2) concomitant marketed AEDs at the time of trial entry.

Exclusion criteria

* Subjects on felbamate with less than 18 months exposure. * Subjects on vigabatrin, whose visual field has not been assessed as per recommendation of the manufacturer, i.e. every 6 months. * Presence of known pseudoseizures within the last year. * Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors. * Uncountable seizures (clusters) or history of convulsive status epilepticus within the last five years.

Design outcomes

Primary

Measure	Time frame
To evaluate efficacy of levetiracetam in community based practice (seizure frequency per week over 16 weeks).	—

Secondary

Measure	Time frame
To assess safety of levetiracetam	—

Outcome results

None listed

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