• Change from Baseline in partial seizure frequency per week over the 14-weeks Treatment Period [ Time Frame: From Baseline to the 14-weeks Treatment Period (4 weeks Up-titration and 10 weeks Evaluation) ] [ Designated as safety issue: No ]

  The change in partial seizure frequency from Baseline (B) over the Treatment Period (T) is given as a percentage reduction computed as:

  (B values- T values) / B values x 100.

  Positive values in percent reduction mean that the value has decreased from Baseline during the first 14-week Period. Partial seizures can be classified into one of the following three groups:

  • Simple partial seizures
  • Complex partial seizures
  • Partial seizures evolving to secondarily generalized seizures.
  
  
• Incidence of Treatment-Emergent Adverse Events (TEAEs) during the Second Period (up to three years until the time of approval granted) [ Time Frame: During the second Period from Visit 8 (Week 22) to the end of the Follow-up Period (up to three years until the time of approval granted) ] [ Designated as safety issue: No ]
  An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with the pharmaceutical product. Incidence of treatment-emergent AEs is reported by the number of subjects with at least one treatment-emergent AE.
  
  

• Change from Baseline in partial seizure frequency per week over the 10-week Evaluation Period [ Time Frame: From Baseline to the 10-weeks Evaluation Period (Week 12 to Week 22) ] [ Designated as safety issue: No ]

  The change in partial seizure frequency from Baseline (B) over the Evaluation Period (E) is given as a percentage reduction computed as:

  (B values- E values) / B values x 100.

  Positive values in percent reduction mean that the value has decreased from Baseline to the 10-week Evaluation Period. Partial seizures can be classified into one of the following three groups:

  • Simple partial seizures
  • Complex partial seizures
  • Partial seizures evolving to secondarily generalized seizures.
  
  
• Partial seizure frequency per week over the 14-weeks Treatment Period [ Time Frame: 14-weeks Treatment Period (4 weeks Up-titration and 10 weeks Evaluation) ] [ Designated as safety issue: No ]

  The seizure frequency per week was calculated as:

  Frequency per week of partial seizures = (Total number of partial seizures in the Treatment Period/number of days for observation in the Treatment Period) x 7.

  Partial seizures can be classified into one of the following three groups:

  • Simple partial seizures
  • Complex partial seizures
  • Partial seizures evolving to secondarily generalized seizures.
  
  
• Partial seizure frequency per week over the 10-weeks Evaluation Period [ Time Frame: 10-weeks Evaluation Period (Week 12 to Week 22) ] [ Designated as safety issue: No ]

  The seizure frequency per week was calculated as:

  Frequency per week of partial seizures = (Total number of partial seizures in the Evaluation Period/number of days for observation in the Evaluation Period) x 7.

  Partial seizures can be classified into one of the following three groups:

  • Simple partial seizures
  • Complex partial seizures
  • Partial seizures evolving to secondarily generalized seizures.
  
  
• Percentage of partial seizures 50 % responders over the 14-weeks Treatment Period [ Time Frame: 14-weeks Treatment Period (4 weeks Up-titration and 10 weeks Evaluation) ] [ Designated as safety issue: No ]

  50 % responders are those subjects which have a 50 % or more reduction in the frequency of partial seizures from Baseline to the Treatment Period.

  Partial seizures can be classified into one of the following three groups:

  • Simple partial seizures
  • Complex partial seizures
  • Partial seizures evolving to secondarily generalized seizures.
  
  
• Percentage of partial seizures 50 % responders over the 10-weeks Evaluation Period [ Time Frame: 10-weeks Evaluation Period (Week 12 to Week 22) ] [ Designated as safety issue: No ]

  50 % responders are those subjects which have a 50 % or more reduction in the frequency of partial seizures from Baseline to the Evaluation Period.

  Partial seizures can be classified into one of the following three groups:

  • Simple partial seizures
  • Complex partial seizures
  • Partial seizures evolving to secondarily generalized seizures.
  
  
• Number of seizure-free subjects over the 14-weeks Treatment Period [ Time Frame: 14-weeks Treatment Period (4 weeks Up-titration and 10 weeks Evaluation) ] [ Designated as safety issue: No ]
  
• Number of seizure-free subjects over the 10-weeks Evaluation Period [ Time Frame: 10-weeks Evaluation Period (Week 12 to Week 22) ] [ Designated as safety issue: No ]
  
• Incidence of treatment-emergent Adverse Drug Reactions (ADRs) during the Second Period (up to three years until the time of approval granted) [ Time Frame: During the second Period from Visit 8 (Week 22) to the end of the Follow-up Period (up to three years until the time of approval granted) ] [ Designated as safety issue: No ]
  An Adverse Drug Reaction (ADR) is an Adverse Event for which a causal relationship between the product and the occurrence is suspected. Incidence of ADRs is reported by the number of subjects with at least one ADR.
  
  
• Change from Baseline in partial seizure frequency per week by 3-month window over the Evaluation Period of the Second Period (up to three years until the time of approval granted) [ Time Frame: From Baseline over the Second Period (excluding the 6-weeks Withdrawal Period) from Visit 8 (Week 22) (up to three years until the time of approval granted) ] [ Designated as safety issue: No ]

  The outcome was also calculated for each 3-month Period but here only the result for the total Evaluation Period is presented.

  Change in partial seizure frequency from Baseline (B) over Evaluation Period (E) is given as a percentage reduction computed as:

  (B values- E values) / B values x 100.

  Positive values in percent reduction show a decrease from Baseline during the Evaluation Period. Partial seizures can be classified into one of the following groups:

  • Simple partial seizures
  • Complex partial seizures
  • Partial seizures evolving to secondarily generalized seizures.
  
  

Objectives of the Second Period: To provide the Levetiracetam treatment to subjects who are judged by the investigators to benefit from the long-term treatment and who are willing to continuously receive this drug. To continuously evaluate the safety of the Levetiracetam long-term administration at doses ranging from 20 mg/kg/day or 1000 mg/day to 60 mg/kg/day or 3000 mg/day in subjects who completed the First Period of this study.