Open Label Safety and Efficacy Study of Levetiracetam in Korean Patients With Epilepsy
Information source: UCB
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy, Partial
Intervention: Levetiracetam (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: UCB Official(s) and/or principal investigator(s):
Beh Kevin, MD, Study Director, Affiliation: UCB
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.
Clinical Details
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 design: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Primary outcome: To evaluate efficacy of levetiracetam in community based practice (seizure frequency per week over 16 weeks).
Secondary outcome: To assess safety of levetiracetam
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: March 2004
Ending date: October 2004
Last updated: March 7, 2008
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