| Primary | Change From Baseline in Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period | 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 decreased from Baseline during the first 14-week Period. Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7. Partial seizures can be classified into:
- Simple partial seizures
- Complex partial seizures
- Partial seizures evolving to secondarily generalized seizures.
| | Posted | | Median | 95% Confidence Interval | Percent reduction | | From Baseline (Week 0-8) to the 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22)); Week 0-22 | | | | ID | Title | Description |
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| OG000 | Levetiracetam |
- First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
- Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
- Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped.
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| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00043.21(26.19 to 52.14)
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| Primary | Incidence of Treatment-Emergent Adverse Events (TEAEs) During the Second Period (up to Three Years Until the Time of Approval Granted) | 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 percentage of subjects with at least one treatment-emergent AE. | | Posted | | Number | | percentage of participants | | 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) | | | | ID | Title | Description |
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| OG000 | Levetiracetam |
- First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
- Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
- Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped.
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| Secondary | Change From Baseline in Partial Seizure Frequency Per Week Over the 10-week Evaluation Period | 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 decreased from Baseline to the 10-week Evaluation Period. Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7. Partial seizures can be classified into:
- Simple partial seizures
- Complex partial seizures
- Partial seizures evolving to secondarily generalized seizures.
| Of the 73 subjects in the FAS, 68 subjects had available data at Baseline and during the Evaluation Period. | Posted | | Median | 95% Confidence Interval | Percent reduction | | From Baseline (Week 0-8) to the 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22) | | | | ID | Title | Description |
|---|
| OG000 | Levetiracetam |
- First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
- Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
- Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped.
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| Secondary | Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period | 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.
| Full Analysis Set (FAS). Only subjects having values unequal to zero over Baseline and values equal to or greater than zero over Treatment Period are included. | Posted | | Median | Inter-Quartile Range | Seizures per week | | 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22)) | | | | ID | Title | Description |
|---|
| OG000 | Levetiracetam |
- First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
- Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
- Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped.
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| Secondary | Partial Seizure Frequency Per Week Over the 10-weeks Evaluation Period | 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.
| Full Analysis Set (FAS). Only subjects having values unequal to zero over Baseline and values equal to or greater than zero over Treatment Period are included. | Posted | | Median | Inter-Quartile Range | Seizures per week | | 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22) | | | | ID | Title | Description |
|---|
| OG000 | Levetiracetam |
- First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
- Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
- Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped.
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| Secondary | Percentage of Partial Seizures 50 % Responders Over the 14-weeks Treatment Period | 50 % responders are those subjects which have a 50 % or more reduction in the frequency of partial seizures from Baseline to the Treatment Period. The results show the percentage of participants that are 50 % responders. 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.
| | Posted | | Number | 95% Confidence Interval | percentage of participants | | 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22)) | | | | ID | Title | Description |
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| OG000 | Levetiracetam |
- First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
- Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
- Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped.
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| Secondary | Percentage of Partial Seizures 50 % Responders Over the 10-weeks Evaluation Period | 50 % responders are those subjects which have a 50 % or more reduction in the frequency of partial seizures from Baseline to the Evaluation Period. The results show the percentage of participants that are 50 % responders. 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.
| Of the 73 subjects in the FAS, 68 subjects had available data over the Evaluation Period. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22) | | | | ID | Title | Description |
|---|
| OG000 | Levetiracetam |
- First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
- Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
- Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped.
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| Secondary | Number of Seizure-free Subjects Over the 14-weeks Treatment Period | Seizure-free means not having a seizure of type I (Partial seizure). 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.
| | Posted | | Number | | participants | | 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22)) | | | | ID | Title | Description |
|---|
| OG000 | Levetiracetam |
- First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
- Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
- Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped.
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| Secondary | Number of Seizure-free Subjects Over the 10-weeks Evaluation Period | Seizure-free means not having a seizure of type I (Partial seizure). 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.
| Of the 73 subjects in the FAS, 68 subjects had available data over the Evaluation Period. | Posted | | Number | | participants | | 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22) | | | | ID | Title | Description |
|---|
| OG000 | Levetiracetam |
- First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
- Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
- Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped.
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| Secondary | Incidence of Treatment-emergent Adverse Drug Reactions (ADRs) During the Second Period (up to Three Years Until the Time of Approval Granted) | 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. | | Posted | | Number | | participants | | 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) | | | | ID | Title | Description |
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| OG000 | Levetiracetam |
- First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
- Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
- Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped.
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| Secondary | Change From Baseline in Partial Seizure Frequency Per Week for the Second Period (up to Three Years From Informed Consent Until the Time of Approval Granted) | The outcome was also calculated for each 3-month Period but here only the result for the total Second Evaluation Period (Second Period without following 6-weeks Withdrawal Period for withdrawers) is presented. Change in partial seizure frequency from Baseline (B) over Second 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. Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7. | | Posted | | Median | Inter-Quartile Range | Percent reduction | | From Baseline (Week 0-8) until the time of approval granted (up to three years from date of informed consent (Week 0); without 6-weeks Withdrawal Period) | | | | ID | Title | Description |
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| OG000 | Levetiracetam |
- First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
- Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
- Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped.
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