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...
Date First Received: September 8, 2005
Last Updated: March 7, 2008
Verified by: UCB, March 2008
Clinical Trial Phase: Phase 3 | Start Date: March 2004
Overall Status: Completed
Estimated Enrollment: 100
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Study Primary Completion Date: October 2004
Intervention(s) in this Clinical Trial
- Drug: Levetiracetam
Outcome Measures for this Clinical Trial
Primary Measures
- To evaluate efficacy of levetiracetam in community based practice (seizure frequency per week over 16 weeks).
Secondary Measures
- To assess safety of levetiracetam
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Clinical Trial Sponsor Information
Lead Sponsor: UCB
Overall Clinical Trial Officials and Contacts
Beh Kevin, MD Study Director UCB
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00160628
Study ID Number: N01099
ClinicalTrials.gov Identifier: NCT00160628
Health Authority: Korea: Food and Drug Administration
Clinical Trials Authorship and Review
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