Levetiracetam Versus Oxcarbazepine as Monotherapy to Evaluate Efficacy and Safety in Subjects With Newly or Recently Diagnosed Partial Epilepsy

Phase 4

Completed

Brief Summary: To evaluate the long term effectiveness of Levetiracetam (LEV) monotherapy on Treatment Failure Rate in subjects with newly diagnosed partial onset seizures with or without secondary generalized seizures, compared to Oxcarbazepine (OXC) monotherapy over 50 weeks from the first dose

Detailed Description: The study duration consists of the following periods:

* Baseline period of one week: Week -1

* Titration period of two weeks: Week 0 to Week 1

* Treatment period of 48 weeks: Week 2 to Week 50

Recruitment & Eligibility

Inclusion Criteria

Male or female subjects from 16 to 80 years, inclusive. Vulnerable subjects (e.g., under 20 years or subject with learning disability but judged to be capable to understand) may only be included where legally permitted and ethically accepted
Subjects with newly or recently diagnosed epilepsy having experienced unprovoked partial seizures (IA, IB, IC with clear focal origin), that are classifiable according to the International Classification of Epileptic seizure (1981). Undiscriminated subjects between IC and IIE could be included
Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year preceding randomization out of which at least 1 unprovoked seizure in the 6 months preceding randomization
Subjects with documented evidence of EEG and brain MRI or CT scan in medical records which were performed within 1 year prior to Visit 1 (V1)
Subjects have no treatment with anti-epileptic drugs in the 6 months preceding this study. The treatment for acute seizure control is acceptable with a maximum of 2 weeks duration and if the treatment was stopped at least 1 week before V1. For Phenobarbital and Phenobarbital derivatives, a minimum of 4 weeks wash-out is requested before V1

Exclusion Criteria

Subject has a current or previous diagnosis of pseudoseizures, conversion disorders, or other non-epileptic ictal events which could be confused with seizures
Subject taking 1 or more of the following medications on a regular basis within 28 days prior to Visit 1: neuroleptics, monoamine oxidase (MAO) inhibitors and narcotic analgesics
Subject taking any immunosuppressant within 28 days prior to Visit 1
Subject has a history of suicide attempt, has received professional counseling for suicidal ideation, or is currently experiencing active suicidal ideation
Subject has a seizure disorder characterized primarily by isolated auras (ie, simple partial seizures without observable motor signs)
Subject suffering from seizures other than partial (IA, IB, IC, with clear focal origin) seizures
Subject has a history of status epilepticus within last 3-month period prior to Visit 1
Subject has seizures that are uncountable due to clustering (ie, an episode lasting less than 30 minutes in which several seizures occur with such frequency that the initiation and completion of each individual seizure cannot be distinguished) during the 12-week period prior to Visit 1 and/or during the Screening Period
Body weight is lower than 40 kg (< 40 kg)

Arm && Interventions

Group	Intervention	Description
Levetiracetam	Levetiracetam	Levetiracetam twice a day treatment group
Oxcarbazepine	Oxcarbazepine	Oxcarbazepine twice a day treatment group

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With a Treatment Failure	Week 0 (First Dose) to Week 50	Treatment failure is defined as (1) Dropout due to related intolerable adverse event, lack of efficacy or need for addition of another Antiepileptic Drug (AED), or (2) need of a 1-step down-Titration, within 50 weeks from the first dose of study medication.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects Who Achieved Seizure Freedom for 24 Consecutive Weeks During the 48 Weeks Treatment Period at Any Time	From Week 2 to Week 50 (During Treatment Period )	24-week Seizure Freedom (rate) defined as the number and percentage of subjects who achieved seizure freedom for 24 consecutive weeks during the Treatment Period at any time
Percentage of Subjects Who Achieved Seizure Freedom During the 48 Weeks Treatment Period	From Week 2 to Week 50 (During Treatment Period )	48-week Seizure Freedom (rate) defined as the number and percentage of subjects who achieved seizure freedom during the Treatment Period
Time to the First Seizure Defined as the Time From the First Dose of Medication to the Occurrence of the First Seizure During the 48 Weeks Treatment Period	From Week 2 to Week 50 (During Treatment Period )

Locations (23): 05
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Busan, Korea, Republic of
10
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Busan, Korea, Republic of
16
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Busan, Korea, Republic of
06
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Daejeon, Korea, Republic of
18
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Daejeon, Korea, Republic of
23
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Gangwon-Do, Korea, Republic of
08
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Goyang-si, Korea, Republic of
09
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Goyang-si, Korea, Republic of
07
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Gwangju, Korea, Republic of
22
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Jung-Gu, Korea, Republic of
01
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Seoul, Korea, Republic of
14
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Seongnam-si, Korea, Republic of
02
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Seoul, Korea, Republic of
04
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Seoul, Korea, Republic of
03
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Seoul, Korea, Republic of
12
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Seoul, Korea, Republic of
11
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Seoul, Korea, Republic of
13
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Seoul, Korea, Republic of
15
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Seoul, Korea, Republic of
17
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Seoul, Korea, Republic of
20
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Seoul, Korea, Republic of
21
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Seoul, Korea, Republic of
19
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Ulsan, Korea, Republic of