Status:
COMPLETED
Open Label Safety and Efficacy Study of Levetiracetam in Korean Patients With Epilepsy
Lead Sponsor:
UCB Pharma
Conditions:
Epilepsy, Partial
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 epilept...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2004
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00160628
Start Date
March 1 2004
End Date
October 1 2004
Last Update
November 26 2013
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