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
1 other identifier
interventional
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2004
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedNovember 26, 2013
February 1, 2010
7 months
September 8, 2005
November 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate efficacy of levetiracetam in community based practice (seizure frequency per week over 16 weeks).
Secondary Outcomes (1)
To assess safety of levetiracetam
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Related Publications (1)
Heo K, Lee BI, Yi SD, Huh K, Kim JM, Lee SA, Shin DJ, Song HK, Lee SK, Kim JY, Lu S, Dubois C, Tonner F. Efficacy and safety of levetiracetam as adjunctive treatment of refractory partial seizures in a multicentre open-label single-arm trial in Korean patients. Seizure. 2007 Jul;16(5):402-9. doi: 10.1016/j.seizure.2007.02.011. Epub 2007 Mar 19.
PMID: 17369059RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
UCB Pharma
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
March 1, 2004
Primary Completion
October 1, 2004
Study Completion
October 1, 2004
Last Updated
November 26, 2013
Record last verified: 2010-02