Open Label Safety and Efficacy Study of Levetiracetam in Korean Patients With Epilepsy
Phase 3
Completed
- Conditions
- Epilepsy, Partial
- Registration Number
- NCT00160628
- Lead Sponsor
- UCB Pharma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To evaluate efficacy of levetiracetam in community based practice (seizure frequency per week over 16 weeks).
- Secondary Outcome Measures
Name Time Method To assess safety of levetiracetam