Open Label Safety and Efficacy Study of Levetiracetam in Korean Patients With Epilepsy
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|ClinicalTrials.gov Identifier: NCT00160628|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : November 26, 2013
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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.
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy, Partial||Drug: Levetiracetam||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||March 2004|
|Actual Primary Completion Date :||October 2004|
|Actual Study Completion Date :||October 2004|
- To evaluate efficacy of levetiracetam in community based practice (seizure frequency per week over 16 weeks).
- To assess safety of levetiracetam
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00160628
|Study Director:||UCB Clinical Trial Call Center||UCB Pharma|
|Other Study ID Numbers:||
|First Posted:||September 12, 2005 Key Record Dates|
|Last Update Posted:||November 26, 2013|
|Last Verified:||February 2010|
Partial Onset Seizures
Central Nervous System Diseases
Nervous System Diseases