Levetiracetam Versus Oxcarbazepine as Monotherapy to Evaluate Efficacy and Safety in Subjects With Newly or Recently Diagnosed Partial Epilepsy
OPTIMAL
A Multi-Center, Open-label, Randomized Study to Evaluate the Long Term Effectiveness of Levetiracetam as Monotherapy in Comparison With Oxcarbazepine in Subjects With Newly or Recently Diagnosed Partial Epilepsy
2 other identifiers
interventional
353
1 country
23
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2011
Typical duration for phase_4
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 21, 2011
CompletedFirst Posted
Study publicly available on registry
December 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedResults Posted
Study results publicly available
August 20, 2015
CompletedAugust 20, 2015
July 1, 2015
3.1 years
December 21, 2011
June 25, 2015
July 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Subjects With a Treatment Failure
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.
Week 0 (First Dose) to Week 50
Secondary Outcomes (3)
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 )
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 )
Percentage of Subjects Who Achieved Seizure Freedom During the 48 Weeks Treatment Period
From Week 2 to Week 50 (During Treatment Period )
Study Arms (2)
Levetiracetam
EXPERIMENTALLevetiracetam twice a day treatment group
Oxcarbazepine
ACTIVE COMPARATOROxcarbazepine twice a day treatment group
Interventions
250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks
150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1week then 600 mg/day 1 week)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
05
Busan, South Korea
10
Busan, South Korea
16
Busan, South Korea
06
Daejeon, South Korea
18
Daejeon, South Korea
23
Gangwon-Do, South Korea
08
Goyang-si, South Korea
09
Goyang-si, South Korea
07
Gwangju, South Korea
22
Junggu, South Korea
14
Seongnam-si, South Korea
01
Seoul, South Korea
02
Seoul, South Korea
03
Seoul, South Korea
04
Seoul, South Korea
11
Seoul, South Korea
12
Seoul, South Korea
13
Seoul, South Korea
15
Seoul, South Korea
17
Seoul, South Korea
20
Seoul, South Korea
21
Seoul, South Korea
19
Ulsan, South Korea
Related Publications (1)
Kim JH, Lee SK, Loesch C, Namgoong K, Lee HW, Hong SB; Korean N01367 Study Group. Comparison of levetiracetam and oxcarbazepine monotherapy among Korean patients with newly diagnosed focal epilepsy: A long-term, randomized, open-label trial. Epilepsia. 2017 Apr;58(4):e70-e74. doi: 10.1111/epi.13707.
PMID: 28395124DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB (Study Director)
- Organization
- UCB Clinical Trial Call Center
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2011
First Posted
December 23, 2011
Study Start
June 1, 2011
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
August 20, 2015
Results First Posted
August 20, 2015
Record last verified: 2015-07