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An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects With Generalized Tonic-clonic Seizures

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ClinicalTrials.gov Identifier: NCT01398956
Recruitment Status : Completed
First Posted : July 21, 2011
Results First Posted : March 9, 2017
Last Update Posted : August 15, 2017
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Tracking Information
First Submitted Date  ICMJE July 13, 2011
First Posted Date  ICMJE July 21, 2011
Results First Submitted Date  ICMJE September 29, 2016
Results First Posted Date  ICMJE March 9, 2017
Last Update Posted Date August 15, 2017
Study Start Date  ICMJE June 2011
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2017)
Incidence of Treatment Emergent Adverse Events During the Entire Study Period [ Time Frame: Through study completion, an average of 3 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 19, 2011)
Incidence of treatment emergent adverse events during the entire study period. [ Time Frame: Evaluation and Withdrawal Periods(up to 3 years) ]
Change History Complete list of historical versions of study NCT01398956 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2017)
  • The Percentage Change in Generalized Tonic-Clonic (GTC) Seizure Frequency Per Week Over the Evaluation Period From Either of the Combined Baseline Periods of the Previous Studies (N01159 or N01363). [ Time Frame: During the Treatment Period (up to 4.8 years) ]
    Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from Baseline of previous studies B over the Treatment Period A is calculated using the equation: Percentage change from Baseline = ((A-B)/B)*100. Percentage change from baseline is not defined for subjects whose baseline information is missing / unknown or equal to zero, or whose seizure frequency per week is missing/unknown. A negative value in change in generalized tonic-clonic (GTC) seizure frequency indicates a reduction of generalized tonic-clonic (GTC) seizure frequency over the Treatment Period.
  • The Incidence of Adverse Drug Reactions During the Entire Study Period [ Time Frame: Through study completion, an average of 3 years ]
    Adverse drug reactions excludes Adverse Events (AEs) described by the investigators with no relationship to study drug.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2011)
  • The percentage reduction in Generalized Tonic-Clonic (GTC) seizure frequency per week over the Evaluation Period from either of the Combined Baseline Periods of the previous studies (N01159 or N01363). [ Time Frame: Baseline of feeder study until end of study(up to 3 years) ]
  • The Incidence of Adverse Drug Reactions During the Entire Study Period [ Time Frame: Evaluation and Withdrawal Periods(up to 3 years) ]
    Adverse drug reactions excludes Adverse Events (AEs) described by the investigators with no relationship to study drug.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects With Generalized Tonic-clonic Seizures
Official Title  ICMJE An Open-label, Multicenter, Long-term, Follow-up Study in Japan to Evaluate the Safety, Tolerability, and Efficacy of Adjunctive Treatment With Oral L059 (Levetiracetam) in Epilepsy Subjects With Generalized Tonic-clonic (GTC) Seizures
Brief Summary The investigators will provide Levetiracetam treatment to epilepsy subjects in Japan who are judged to benefit from continued treatment with Levetiracetam by the investigators and who are willing to continuously receive this drug.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Epilepsy
  • Generalized Tonic-clonic Seizures
Intervention  ICMJE Drug: Levetiracetam

formulation: tablet or dry syrup

strength: 250 mg tablet, 500 mg tablet, dry syrup 50%

dosage: Sb ≥16 years and ≥4 and <16 years (≥50 kg): 1000 mg/day, 2000 mg/day or 3000 mg/day; Sb ≥4 and <16 years (<50kg): 20 mg/kg/day, 40 mg/kg/day, or 60 mg/kg/day

frequency: twice daily

Other Name: Keppra, E Keppra
Study Arms  ICMJE Experimental: Levetiracetam
Twice daily (morning and evening) orally
Intervention: Drug: Levetiracetam
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: January 10, 2014)
44
Original Estimated Enrollment  ICMJE
 (submitted: July 19, 2011)
76
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The subject in Japan has completed either of the studies N01159 or N01363 or has discontinued the N01159 study due to lack of efficacy.
  • The subject who is judged to benefit from continued treatment with Levetiracetam by the investigators

Exclusion Criteria:

  • Subjects with multiple protocol deviations during N01159 or N01363, such as missing laboratory data, and low or noncompliance with the study medication, and who the investigator considers not to have the potential to have deviations stopped are ineligible
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01398956
Other Study ID Numbers  ICMJE N01361
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma
Study Sponsor  ICMJE UCB Pharma
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