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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. )

Tracking Information
First Submitted Date  ICMJE December 21, 2011
First Posted Date  ICMJE December 23, 2011
Results First Submitted Date  ICMJE June 25, 2015
Results First Posted Date  ICMJE August 20, 2015
Last Update Posted Date August 20, 2015
Study Start Date  ICMJE June 2011
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2011)
Percentage of subjects who dropped out due to Treatment Failure after 50 weeks from the first dose of study medication [ Time Frame: Week 0 (First Dose) to Week 50 ]
Treatment Failure Rate defined as the percentage of subjects who dropped out due to treatment failure at the maximum tolerated dose, after 50 weeks from the first dose of study medication. Treatment failure is defined as meeting at least 1 of the following treatment failure criteria:
  • Lack of efficacy; the occurrence of a seizure at the maximum tolerated dose
  • Need for the addition of another Antiepileptic Drug (AED)
  • The occurrence of an intolerable adverse event related to study medication
Change History Complete list of historical versions of study NCT01498822 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2011)
  • 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 ) ]
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Levetiracetam Versus Oxcarbazepine as Monotherapy to Evaluate Efficacy and Safety in Subjects With Newly or Recently Diagnosed Partial Epilepsy
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE
  • 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
  • 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)
Study Arms  ICMJE
  • Experimental: Levetiracetam
    Levetiracetam twice a day treatment group
    Intervention: Drug: Levetiracetam
  • Active Comparator: Oxcarbazepine
    Oxcarbazepine twice a day treatment group
    Intervention: Drug: Oxcarbazepine
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 26, 2014)
353
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2011)
352
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01498822
Other Study ID Numbers  ICMJE N01367
2014-002713-32 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma ( Korea UCB Co., Ltd. )
Study Sponsor  ICMJE Korea UCB Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
PRS Account UCB Pharma
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP