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

This study has been completed.
Information provided by (Responsible Party):
UCB Pharma ( Korea UCB Co., Ltd. )
ClinicalTrials.gov Identifier:
First received: December 21, 2011
Last updated: July 24, 2015
Last verified: July 2015
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

Condition Intervention Phase
Drug: Levetiracetam
Drug: Oxcarbazepine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Percentage of Subjects With a Treatment Failure [ Time Frame: Week 0 (First Dose) to Week 50 ] [ Designated as safety issue: No ]
    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:
  • 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 [ Time Frame: From Week 2 to Week 50 (During Treatment Period ) ] [ Designated as safety issue: No ]
  • Percentage of Subjects Who Achieved Seizure Freedom for 24 Consecutive Weeks During the 48 Weeks Treatment Period at Any Time [ Time Frame: From Week 2 to Week 50 (During Treatment Period ) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From Week 2 to Week 50 (During Treatment Period ) ] [ Designated as safety issue: No ]
    48-week Seizure Freedom (rate) defined as the number and percentage of subjects who achieved seizure freedom during the Treatment Period

Enrollment: 353
Study Start Date: June 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levetiracetam
Levetiracetam twice a day treatment group
Drug: Levetiracetam
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
Active Comparator: Oxcarbazepine
Oxcarbazepine twice a day treatment group
Drug: Oxcarbazepine
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)

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

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01498822

Korea, Republic of
Busan, Korea, Republic of
Busan, Korea, Republic of
Busan, Korea, Republic of
Daejeon, Korea, Republic of
Daejeon, Korea, Republic of
Gangwon-Do, Korea, Republic of
Goyang-si, Korea, Republic of
Goyang-si, Korea, Republic of
Gwangju, Korea, Republic of
Jung-Gu, Korea, Republic of
Seongnam-si, Korea, Republic of
Seoul, Korea, Republic of
Seoul, Korea, Republic of
Seoul, Korea, Republic of
Seoul, Korea, Republic of
Seoul, Korea, Republic of
Seoul, Korea, Republic of
Seoul, Korea, Republic of
Seoul, Korea, Republic of
Seoul, Korea, Republic of
Seoul, Korea, Republic of
Seoul, Korea, Republic of
Ulsan, Korea, Republic of
Sponsors and Collaborators
Korea UCB Co., Ltd.
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
No publications provided

Responsible Party: UCB Pharma ( Korea UCB Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01498822     History of Changes
Other Study ID Numbers: N01367, 2014-002713-32
Study First Received: December 21, 2011
Results First Received: June 25, 2015
Last Updated: July 24, 2015
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by UCB Pharma:
treatment failure
partial epilepsy

Additional relevant MeSH terms:
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Analgesics, Non-Narcotic
Antimanic Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Nootropic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Psychotropic Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Tranquilizing Agents
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 27, 2015