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Trial record 1 of 1 for:    NCT01498822
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Levetiracetam Versus Oxcarbazepine as Monotherapy to Evaluate Efficacy and Safety in Subjects With Newly or Recently Diagnosed Partial Epilepsy (OPTIMAL)

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ClinicalTrials.gov Identifier: NCT01498822
Recruitment Status : Completed
First Posted : December 23, 2011
Results First Posted : August 20, 2015
Last Update Posted : August 20, 2015
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( Korea UCB Co., Ltd. )

Study Description
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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

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Levetiracetam Drug: Oxcarbazepine Phase 4

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 353 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Subjects With a Treatment Failure [ Time Frame: 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 :
  1. 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 ) ]
  2. 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 ) ]
    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

  3. Percentage of Subjects Who Achieved Seizure Freedom During the 48 Weeks Treatment Period [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01498822


Locations
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Sponsors and Collaborators
Korea UCB Co., Ltd.
Investigators
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Korea UCB Co., Ltd.
ClinicalTrials.gov Identifier: NCT01498822    
Other Study ID Numbers: N01367
2014-002713-32 ( EudraCT Number )
First Posted: December 23, 2011    Key Record Dates
Results First Posted: August 20, 2015
Last Update Posted: August 20, 2015
Last Verified: July 2015
Keywords provided by UCB Pharma ( Korea UCB Co., Ltd. ):
Levetiracetam
Oxcarbazepine
treatment failure
partial epilepsy
Additional relevant MeSH terms:
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Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Oxcarbazepine
Levetiracetam
Anticonvulsants
 Nootropic Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers