| Primary | Percentage Change From Baseline in Seizure Frequency Per Week of Partial Onset Seizures (Type I) During the Up-titration Period | Calculated as (7-day seizure frequency during the up-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12). | The intention-to-treat (ITT) set included 31 subjects, who took at least one dose of trial medication. | Posted | | Median | Inter-Quartile Range | percentage of change | | During the Up-titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4) | | | | ID | Title | Description |
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| OG000 | Seletracetam | Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-30.88(-50.00 to -15.38)
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| Secondary | Percentage Change From Baseline in Seizure Frequency Per Week of Partial Onset Seizures (Type I) by Visit Over the Treatment Period (Up-titration + Down-titration) | Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x. | The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for partial (Type I) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit. | Posted | | Median | Inter-Quartile Range | percentage of change | | During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4) | | | | ID | Title | Description |
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| OG000 | Seletracetam | Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules. |
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| Secondary | Percentage Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Overall in the Down-titration Period | Calculated as (7-day seizure frequency during the down-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15). | The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for partial (Type I) seizure frequency per week in the down-titration period are included in the analysis. | Posted | | Median | Inter-Quartile Range | percentage of change | | During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4) | | | | ID | Title | Description |
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| OG000 | Seletracetam | Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules. |
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| Secondary | Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) by Visit Over the Treatment Period (Up-titration + Down-titration) | Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in seizure frequency from Baseline. The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x. | The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for all types (Type I+II+III) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit. | Posted | | Median | Inter-Quartile Range | percentage of change | | During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4) | | | | ID | Title | Description |
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| OG000 | Seletracetam | Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules. |
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| Secondary | Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in the Up-titration Period | Calculated as (7-day seizure frequency during the up-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in seizure frequency from Baseline. The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12). | The ITT set included 31 subjects, who took at least one dose of trial medication. | Posted | | Median | Inter-Quartile Range | percentage of change | | During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4) | | | | ID | Title | Description |
|---|
| OG000 | Seletracetam | Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules. |
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| Secondary | Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in the Down-titration Period | Calculated as (7-day seizure frequency during the down-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in seizure frequency from Baseline. The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15). | The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for all types (Type I+II+III) seizure frequency per week in the down-titration period are included in the analysis. | Posted | | Median | Inter-Quartile Range | percentage of change | | During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4) | | | | ID | Title | Description |
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| OG000 | Seletracetam | Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules. |
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| Secondary | Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period | Calculated as 7-day partial onset seizure (type I) frequency; The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x. | The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for partial (Type I) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit. | Posted | | Median | Inter-Quartile Range | seizures per week | | During the Treatment Period (Week 5 to Week 15) | | | | ID | Title | Description |
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| OG000 | Seletracetam | Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules. |
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| Secondary | Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Treatment Period | Calculated as 7-day partial onset seizure (type I) frequency. The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). | The ITT set included 31 subjects, who took at least one dose of trial medication. | Posted | | Median | Inter-Quartile Range | seizures per week | | During the Treatment Period (Week 5 to Week 15) | | | | ID | Title | Description |
|---|
| OG000 | Seletracetam | Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules. |
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| Secondary | Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Up-titration Period | Calculated as 7-day partial onset seizure (type I) frequency. The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12). | The ITT set included 31 subjects, who took at least one dose of trial medication. | Posted | | Median | Inter-Quartile Range | seizures per week | | During the Up-Titration Period (Week 5 to Week 12) | | | | ID | Title | Description |
|---|
| OG000 | Seletracetam | Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules. |
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| Secondary | Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Down-titration Period | Calculated as 7-day partial onset seizure (type I) frequency. The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15). | The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for partial (Type I) seizure frequency per week in the down-titration period are included in the analysis. | Posted | | Median | Inter-Quartile Range | seizures per week | | During the Down-Titration Period (Week 13 to Week 15) | | | | ID | Title | Description |
|---|
| OG000 | Seletracetam | Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules. |
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| Secondary | Seizure Frequency Per Week for All Seizure Types (Type I+II+III) by Visit Over the Treatment Period | Calculated as 7-day seizure frequency for all seizure types (type I+II+III). The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x. | The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for all types (type I+II+III) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit. | Posted | | Median | Inter-Quartile Range | seizures per week | | During the Treatment Period (Week 5 to Week 15) | | | | ID | Title | Description |
|---|
| OG000 | Seletracetam | Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules. |
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| Secondary | Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Treatment Period | Calculated as 7-day seizure frequency for all seizure types (type I+II+III). The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). | The ITT set included 31 subjects, who took at least one dose of trial medication. | Posted | | Median | Inter-Quartile Range | seizures per week | | During the Treatment Period (Week 5 to Week 15) | | | | ID | Title | Description |
|---|
| OG000 | Seletracetam | Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules. |
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| Secondary | Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Up-titration Period | Calculated as 7-day seizure frequency for all seizure types (type I+II+III). The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12). | The ITT set included 31 subjects, who took at least one dose of trial medication. | Posted | | Median | Inter-Quartile Range | seizures per week | | During the Up-Titration Period (Week 5 to Week 12) | | | | ID | Title | Description |
|---|
| OG000 | Seletracetam | Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules. |
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| Secondary | Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Down-titration Period | Calculated as 7-day seizure frequency for all seizure types (type I+II+III). The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15). | The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for Type I+II+III seizure frequency per week in the down-titration period are included in the analysis. | Posted | | Median | Inter-Quartile Range | seizures per week | | During the Down-Titration Period (Week 13 to Week 15) | | | | ID | Title | Description |
|---|
| OG000 | Seletracetam | Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules. |
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| Secondary | Responder Rate in Partial Onset Seizures (Type I) Over the Up-titration Period | A responder was defined as a subject with a >= 50% reduction in seizure frequency per week from the Baseline Period (Week 1 to Week 4) to the end of the Up-Titration Period. | The ITT set included 31 subjects, who took at least one dose of trial medication. | Posted | | Number | | percentage of participants | | Week 12, compared to Baseline Period (Week 1 to Week 4) | | | | ID | Title | Description |
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| OG000 | Seletracetam | Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules. |
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| Secondary | Percentage of Participants With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period | Categories of percentage change in seizures from Baseline were as following: < -25%; -25% to <25%; 25% to <75%; 75% to <100%; 100%. | The ITT set included 31 subjects, who took at least one dose of trial medication. | Posted | | Number | | percentage of participants | | Week 12, compared to Baseline Period (Week 1 to Week 4) | | | | ID | Title | Description |
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| OG000 | Seletracetam | Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules. |
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| Secondary | Percentage Change From Baseline in Seizure-free Days Per Week Over the Up-titration Period | A day was considered seizure-free, if no seizure was reported during 24 hours. | The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for seizure-free days per week over the up-titration period are included in the analysis. | Posted | | Median | Inter-Quartile Range | percentage of change | | Week 5 to Week 12, compared to Baseline Period (Week 1 to Week 4) | | | | ID | Title | Description |
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| OG000 | Seletracetam | Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules. |
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| Secondary | Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Overall in the Down-titration Period | Calculated as (7-day seizure frequency during the down-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). A negative value in change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15). | The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for partial (Type I) seizure frequency per week in the down-titration period are included in the analysis. | Posted | | Median | Inter-Quartile Range | seizures per week | | During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4) | | | | ID | Title | Description |
|---|
| OG000 | Seletracetam | Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules. |
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| Secondary | Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) During the Up-titration Period | Calculated as (7-day seizure frequency during the up-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). A negative value in change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12). | The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for partial (Type I) seizure frequency per week in the down-titration period are included in the analysis. | Posted | | Median | Inter-Quartile Range | seizures per week | | Week 5 to Week 12, compared to Baseline Period (Week 1 to Week 4) | | | | ID | Title | Description |
|---|
| OG000 | Seletracetam | Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules. |
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| Secondary | Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) Overall in the Down-titration Period | Calculated as (7-day seizure frequency during the down-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). A negative value in change from Baseline indicates a decrease in all seizure types frequency from Baseline. The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15). | The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for all types (Type I+II+III) seizure frequency per week in the down-titration period are included in the analysis. | Posted | | Median | Inter-Quartile Range | seizures per week | | Week 13 to Week 15, compared to Baseline Period (Week 1 to Week 4) | | | | ID | Title | Description |
|---|
| OG000 | Seletracetam | Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules. |
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| Secondary | Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II +III) Overall in the Up-titration Period | Calculated as (7-day seizure frequency during the up-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). A negative value in change from Baseline indicates a decrease in all seizure types frequency from Baseline. The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12). | The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for all types (Type I+II+III) seizure frequency per week in the down-titration period are included in the analysis. | Posted | | Median | Inter-Quartile Range | seizures per week | | Week 5 to Week 12, compared to Baseline Period (Week 1 to Week 4) | | | | ID | Title | Description |
|---|
| OG000 | Seletracetam | Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules. |
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| Secondary | Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period (Up-titration + Down-titration) | Calculated as (7-day seizure frequency during the treatment period for visit n) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). The treatment period referred to includes the period from the previous visit n-1 up to but not including the specific visit n. A negative value in change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The Overall Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). | The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for partial (Type I) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit. | Posted | | Median | Inter-Quartile Range | seizures per week | | Week 5 to Week 15, compared to Baseline Period (Week 1 to Week 4) | | | | ID | Title | Description |
|---|
| OG000 | Seletracetam | Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules. |
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| Secondary | Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) by Visit Over the Treatment Period (Up-titration + Down-titration) | Calculated as (7-day seizure frequency during the treatment period for visit n) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). The treatment period referred to includes the period from the previous visit n-1 up to but not including the specific visit n. A negative value in change from Baseline indicates a decrease in all seizure types frequency from Baseline. The Overall Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). | The ITT set included 31 subjects, who took at least one dose of trial medication. Only subjects with valid data for all types (Type I+II+III) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit. | Posted | | Median | Inter-Quartile Range | seizures per week | | Week 5 to Week 15, compared to Baseline Period (Week 1 to Week 4) | | | | ID | Title | Description |
|---|
| OG000 | Seletracetam | Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules. |
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