To assess the long-term effects of levetiracetam on retention rate in subjects with refractory partial onset seizure that are not fully controlled with 1 to 3 concomitant antiepileptic drugs, compared to topiramate as add-on therapy during 52 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
343
250 mg and 500 mg levetiracetam tablet 1000 mg/day (500 mg bid) levetiracetam (maximum to 3000 mg/day) Duration: maximum 52 weeks
25 mg and 100 mg topiramate tablet 100 mg/day(50 mg bid) topiramate (maximum to 400 mg/day) Duration: maximum 52 weeks
14
Busan, South Korea
21
Busan, South Korea
8
Busan, South Korea
Percentage of Subjects Continuing the Allocated Investigational Treatment From the First Study Treatment Intake to Week 52, After the Beginning of Investigational Treatment With Levetiracetam Compared to Topiramate
Time frame: From Baseline to Week 52
Number of Subjects With at Least One Adverse Event Reported During the Trial Period From Baseline to Week 52
Time frame: From Baseline to Week 52
Time From the First Study Treatment Intake to Drug Discontinuation Due to Adverse Event (AE)
Time frame: From Baseline to Week 52
Median Percent Reduction in the Weekly Partial Onset Seizure (POS) Frequency From Baseline During the Total Treatment Period From Baseline to Week 52
Reduction from baseline was defined as baseline value minus post-baseline value and therefore is the negative of the change from baseline value.
Time frame: From Baseline to Week 52
Responders Defined as Number of Subjects With at Least 50 % Reduction in the Weekly POS Frequency From Baseline During the Total Treatment Period From Baseline to Week 52
Time frame: From Baseline to Week 52
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9
Busan, South Korea
12
Daegu, South Korea
13
Daegu, South Korea
10
Daejeon, South Korea
25
Daejeon, South Korea
15
Gwangju, South Korea
7
Incheon, South Korea
...and 14 more locations