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Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures

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ClinicalTrials.gov Identifier: NCT01954121
Recruitment Status : Completed
First Posted : October 1, 2013
Results First Posted : August 11, 2016
Last Update Posted : August 15, 2017
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )

Tracking Information
First Submitted Date  ICMJE September 26, 2013
First Posted Date  ICMJE October 1, 2013
Results First Submitted Date  ICMJE March 18, 2016
Results First Posted Date  ICMJE August 11, 2016
Last Update Posted Date August 15, 2017
Study Start Date  ICMJE September 2013
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2013)
Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period [ Time Frame: 6-months Evaluation Period (From Week 4 to Week 30) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01954121 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2016)
  • Proportion of Subjects Retained in the Study for the Duration of the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period [ Time Frame: From Week 1 to Week 30 ]
  • Time to First Seizure or Discontinuation Due to an Adverse Event (AE) / Lack of Efficacy (LOE) During the Evaluation Period [ Time Frame: From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30) ]
    Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.
  • Time to First Seizure During the Evaluation Period [ Time Frame: From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30) ]
    Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.
  • Time to First Seizure During the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period From the First Dose of Study Drug [ Time Frame: From Randomization (Week 1) up to Evaluation Visit (Week 30) ]
    Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2013)
  • Proportion of Subjects Retained in the Study for the Duration of the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period [ Time Frame: From Week 1 to Week 30 ]
  • Time to First Seizure or Discontinuation Due to an Adverse Event (AE) / Lack of Efficacy (LOE) During the Evaluation Period [ Time Frame: From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30) ]
  • Time to First Seizure During the Evaluation Period [ Time Frame: From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30) ]
  • Time to First Seizure During the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period From the First Dose of Study Drug [ Time Frame: From Randomization (Week 1) up to Evaluation Visit (Week 30) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures
Official Title  ICMJE An Open-label, Randomized, Parallel-group, Active-controlled Study Comparing the Efficacy and Safety of Levetiracetam to Carbamazepine Used as Monotherapy in Subjects Newly or Recently Diagnosed as Epilepsy and Partial-onset Seizures
Brief Summary To demonstrate the non-inferiority of Levetiracetam (1000 mg/day) versus Carbamazepine Immediate-Release (400 mg/day) used as monotherapy for at least 6 months in a Chinese population with newly or recently diagnosed Epilepsy who are experiencing Partial-Onset Seizures (POS).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Epilepsy
  • Partial Seizures
Intervention  ICMJE
  • Drug: Levetiracetam

    Immediate release film-coated tablets at strengths of 250 mg and 500 mg.

    • Up-titration Period (Week 1 to Week 3): Levetiracetam (LEV) 250 mg twice daily (bid)
    • Stabilization Period and Evaluation Period (Week 3 to Week 30): LEV 500 mg bid
    • Down-titration Period (Week 30 up to Week 33)
    Other Name: Keppra
  • Drug: Carbamazepine

    Immediate release tablets at a strength of 200 mg.

    • Up-titration Period (Week 1 to Week 3): Carbamazepine- Immediate Release (CBZ-IR) 200 mg once daily (qd)
    • Stabilization Period and Evaluation Period (Week 3 to Week 30): CBZ-IR 200 mg bid
    • Down-titration Period (Week 30 up to Week 33)
    Other Name: Tegretol
Study Arms  ICMJE
  • Experimental: Levetiracetam
    Levetiracetam 1000 mg/day
    Intervention: Drug: Levetiracetam
  • Active Comparator: Carbamazepine
    Carbamazepine 400 mg/day
    Intervention: Drug: Carbamazepine
Publications * Not Provided

*   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: September 26, 2013)
436
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is of Chinese origin and ≥ 16 years of age
  • Subject is newly or recently diagnosed with Epilepsy, having experienced unprovoked Partial-Onset Seizures (POS)
  • Subject has experienced at least 2 unprovoked seizures in the year preceding randomization, of which at least 1 unprovoked seizure occurred in the 3 months preceding randomization
  • Subject has had an Electroencephalogram (EEG) and a brain Computed Tomography (CT) scan or brain Magnetic Resonance Imaging (MRI) scan consistent with a diagnosis of Epilepsy with POS

Exclusion Criteria:

  • Subject tests positive for human leukocyte antigen major histocompatibility complex, class I,B (HLA-B)* 1502 allele
  • Subject has a history or presence of seizures of other types than Partial-Onset Seizures (POS)
  • Subject has only experienced type IA nonmotor seizures
  • Subject has a history or presence of seizures occurring only in clustered patterns
  • Subject has a history of clinical or Electroencephalogram (EEG) findings suggestive of Idiopathic Generalized Epilepsy prior to randomization
  • Subject has current or previous diagnosis of pseudoseizures, conversion disorders, or other nonepileptic ictal events that could be confused with seizures
  • Subject has a history of Status Epilepticus
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (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 China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01954121
Other Study ID Numbers  ICMJE N01364
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma ( UCB Pharma SA )
Study Sponsor  ICMJE UCB Pharma SA
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 2017

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