Trial Outcomes & Findings for Study With Seletracetam (Ucb 44212) in Adult Subjects (18 to 65 Years) With Partial Onset Seizures (NCT NCT00152451)
NCT ID: NCT00152451
Last Updated: 2024-03-29
Results Overview
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).
COMPLETED
PHASE2
31 participants
During the Up-titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)
2024-03-29
Participant Flow
The study started to enroll patients in May 2005 and concluded in May 2006.
Participant Flow refers to the Intention-To-Treat Set. The study consisted of a 4-week Baseline Period, a 11-week Treatment Period (Up-/Down-Titration) and a 2-week Post-Treatment Period. Patients were up-titrated every two weeks until the maximum tolerated dose was reached. They were maintained at this dose until the end of the 8-week Up-Titration Period and continue that dose until the Down-Titration Visit scheduled for that dose level. Patients were to be down-titrated over a 3-week Period.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
Baseline Characteristics
Study With Seletracetam (Ucb 44212) in Adult Subjects (18 to 65 Years) With Partial Onset Seizures
Baseline characteristics by cohort
| Measure |
Seletracetam
n=31 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
44.41 years
STANDARD_DEVIATION 10.15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the Up-titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)Population: The intention-to-treat (ITT) set included 31 subjects, who took at least one dose of trial medication.
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).
Outcome measures
| Measure |
Seletracetam
n=31 Participants
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.
|
|---|---|
|
Percentage Change From Baseline in Seizure Frequency Per Week of Partial Onset Seizures (Type I) During the Up-titration Period
|
-30.88 percentage of change
Interval -50.0 to -15.38
|
SECONDARY outcome
Timeframe: During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)Population: 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.
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.
Outcome measures
| Measure |
Seletracetam
n=31 Participants
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.
|
|---|---|
|
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)
Visit 4 (Week 5 and 6)
|
-40.06 percentage of change
Interval -68.75 to 1.73
|
|
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)
Visit 5 (Week 7 and 8)
|
-37.50 percentage of change
Interval -51.79 to -0.75
|
|
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)
Visit 6 (Week 9 and 10)
|
-27.68 percentage of change
Interval -53.12 to -14.29
|
|
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)
Visit 7 (Week 11 and 12)
|
-39.88 percentage of change
Interval -70.83 to -24.37
|
|
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)
Visit 8 (Week 13)
|
-39.33 percentage of change
Interval -56.76 to -1.69
|
|
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)
Visit 9 (Week 14)
|
-41.67 percentage of change
Interval -61.19 to 25.0
|
|
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)
Visit 10 (Week 15)
|
-33.33 percentage of change
Interval -83.07 to 58.65
|
SECONDARY outcome
Timeframe: During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4)Population: 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.
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).
Outcome measures
| Measure |
Seletracetam
n=27 Participants
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.
|
|---|---|
|
Percentage Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Overall in the Down-titration Period
|
-36.36 percentage of change
Interval -64.29 to 21.81
|
SECONDARY outcome
Timeframe: During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)Population: 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.
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.
Outcome measures
| Measure |
Seletracetam
n=31 Participants
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.
|
|---|---|
|
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)
Visit 4 (Week 5 and 6)
|
-40.06 percentage of change
Interval -68.75 to 3.29
|
|
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)
Visit 5 (Week 7 and 8)
|
-37.50 percentage of change
Interval -51.79 to -0.75
|
|
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)
Visit 6 (Week 9 and 10)
|
-27.68 percentage of change
Interval -53.12 to -14.29
|
|
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)
Visit 7 (Week 11 and 12)
|
-39.88 percentage of change
Interval -70.83 to -24.37
|
|
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)
Visit 8 (Week 13)
|
-39.33 percentage of change
Interval -56.76 to -1.69
|
|
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)
Visit 9 (Week 14)
|
-41.67 percentage of change
Interval -61.19 to 25.0
|
|
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)
Visit 10 (Week 15)
|
-33.33 percentage of change
Interval -83.07 to 58.65
|
SECONDARY outcome
Timeframe: During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)Population: The ITT set included 31 subjects, who took at least one dose of trial medication.
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).
Outcome measures
| Measure |
Seletracetam
n=31 Participants
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.
|
|---|---|
|
Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in the Up-titration Period
|
-30.88 percentage of change
Interval -50.0 to -15.38
|
SECONDARY outcome
Timeframe: During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4)Population: 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.
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).
Outcome measures
| Measure |
Seletracetam
n=27 Participants
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.
|
|---|---|
|
Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in the Down-titration Period
|
-36.36 percentage of change
Interval -64.29 to 21.81
|
SECONDARY outcome
Timeframe: During the Treatment Period (Week 5 to Week 15)Population: 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.
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.
Outcome measures
| Measure |
Seletracetam
n=31 Participants
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.
|
|---|---|
|
Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period
Visit 4 (Week 5 and 6)
|
2.50 seizures per week
Interval 1.0 to 10.5
|
|
Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period
Visit 5 (Week 7 and 8)
|
3.73 seizures per week
Interval 1.0 to 13.0
|
|
Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period
Visit 6 (Week 9 and 10)
|
2.55 seizures per week
Interval 1.5 to 13.5
|
|
Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period
Visit 7 (Week 11 and 12)
|
2.50 seizures per week
Interval 0.88 to 8.62
|
|
Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period
Visit 8 (Week 13)
|
3.00 seizures per week
Interval 1.0 to 13.0
|
|
Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period
Visit 9 (Week 14)
|
4.00 seizures per week
Interval 2.0 to 13.22
|
|
Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period
Visit 10 (Week 15)
|
4.38 seizures per week
Interval 1.75 to 14.0
|
SECONDARY outcome
Timeframe: During the Treatment Period (Week 5 to Week 15)Population: The ITT set included 31 subjects, who took at least one dose of trial medication.
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).
Outcome measures
| Measure |
Seletracetam
n=31 Participants
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.
|
|---|---|
|
Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Treatment Period
|
2.74 seizures per week
Interval 1.71 to 11.76
|
SECONDARY outcome
Timeframe: During the Up-Titration Period (Week 5 to Week 12)Population: The ITT set included 31 subjects, who took at least one dose of trial medication.
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).
Outcome measures
| Measure |
Seletracetam
n=31 Participants
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.
|
|---|---|
|
Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Up-titration Period
|
2.25 seizures per week
Interval 1.63 to 9.82
|
SECONDARY outcome
Timeframe: During the Down-Titration Period (Week 13 to Week 15)Population: 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.
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).
Outcome measures
| Measure |
Seletracetam
n=27 Participants
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.
|
|---|---|
|
Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Down-titration Period
|
3.50 seizures per week
Interval 1.75 to 13.7
|
SECONDARY outcome
Timeframe: During the Treatment Period (Week 5 to Week 15)Population: 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.
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.
Outcome measures
| Measure |
Seletracetam
n=31 Participants
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.
|
|---|---|
|
Seizure Frequency Per Week for All Seizure Types (Type I+II+III) by Visit Over the Treatment Period
Visit 4 (Week 5 and 6)
|
2.50 seizures per week
Interval 1.0 to 10.5
|
|
Seizure Frequency Per Week for All Seizure Types (Type I+II+III) by Visit Over the Treatment Period
Visit 5 (Week 7 and 8)
|
3.73 seizures per week
Interval 1.0 to 13.0
|
|
Seizure Frequency Per Week for All Seizure Types (Type I+II+III) by Visit Over the Treatment Period
Visit 6 (Week 9 and 10)
|
2.55 seizures per week
Interval 1.5 to 13.5
|
|
Seizure Frequency Per Week for All Seizure Types (Type I+II+III) by Visit Over the Treatment Period
Visit 7 (Week 11 and 12)
|
2.50 seizures per week
Interval 0.88 to 8.62
|
|
Seizure Frequency Per Week for All Seizure Types (Type I+II+III) by Visit Over the Treatment Period
Visit 8 (Week 13)
|
3.00 seizures per week
Interval 1.0 to 13.0
|
|
Seizure Frequency Per Week for All Seizure Types (Type I+II+III) by Visit Over the Treatment Period
Visit 9 (Week 14)
|
4.00 seizures per week
Interval 2.0 to 13.22
|
|
Seizure Frequency Per Week for All Seizure Types (Type I+II+III) by Visit Over the Treatment Period
Visit 10 (Week 15)
|
4.38 seizures per week
Interval 1.75 to 14.0
|
SECONDARY outcome
Timeframe: During the Treatment Period (Week 5 to Week 15)Population: The ITT set included 31 subjects, who took at least one dose of trial medication.
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).
Outcome measures
| Measure |
Seletracetam
n=31 Participants
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.
|
|---|---|
|
Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Treatment Period
|
2.74 seizures per week
Interval 1.71 to 11.76
|
SECONDARY outcome
Timeframe: During the Up-Titration Period (Week 5 to Week 12)Population: The ITT set included 31 subjects, who took at least one dose of trial medication.
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).
Outcome measures
| Measure |
Seletracetam
n=31 Participants
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.
|
|---|---|
|
Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Up-titration Period
|
2.25 seizures per week
Interval 1.63 to 9.82
|
SECONDARY outcome
Timeframe: During the Down-Titration Period (Week 13 to Week 15)Population: 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.
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).
Outcome measures
| Measure |
Seletracetam
n=27 Participants
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.
|
|---|---|
|
Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Down-titration Period
|
3.50 seizures per week
Interval 1.75 to 13.7
|
SECONDARY outcome
Timeframe: Week 12, compared to Baseline Period (Week 1 to Week 4)Population: The ITT set included 31 subjects, who took at least one dose of trial medication.
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.
Outcome measures
| Measure |
Seletracetam
n=31 Participants
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.
|
|---|---|
|
Responder Rate in Partial Onset Seizures (Type I) Over the Up-titration Period
|
25.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12, compared to Baseline Period (Week 1 to Week 4)Population: The ITT set included 31 subjects, who took at least one dose of trial medication.
Categories of percentage change in seizures from Baseline were as following: \< -25%; -25% to \<25%; 25% to \<75%; 75% to \<100%; 100%.
Outcome measures
| Measure |
Seletracetam
n=31 Participants
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.
|
|---|---|
|
Percentage of Participants With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period
< -25%
|
3.2 percentage of participants
|
|
Percentage of Participants With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period
-25% to < 25%
|
35.5 percentage of participants
|
|
Percentage of Participants With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period
25% to < 75%
|
51.6 percentage of participants
|
|
Percentage of Participants With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period
75% to <100%
|
3.2 percentage of participants
|
|
Percentage of Participants With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period
100%
|
6.5 percentage of participants
|
SECONDARY outcome
Timeframe: Week 5 to Week 12, compared to Baseline Period (Week 1 to Week 4)Population: 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.
A day was considered seizure-free, if no seizure was reported during 24 hours.
Outcome measures
| Measure |
Seletracetam
n=29 Participants
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.
|
|---|---|
|
Percentage Change From Baseline in Seizure-free Days Per Week Over the Up-titration Period
|
13.80 percentage of change
Interval 4.71 to 28.57
|
SECONDARY outcome
Timeframe: During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4)Population: 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.
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).
Outcome measures
| Measure |
Seletracetam
n=27 Participants
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.
|
|---|---|
|
Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Overall in the Down-titration Period
|
-0.96 seizures per week
Interval -3.0 to 1.41
|
SECONDARY outcome
Timeframe: Week 5 to Week 12, compared to Baseline Period (Week 1 to Week 4)Population: 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.
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).
Outcome measures
| Measure |
Seletracetam
n=31 Participants
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.
|
|---|---|
|
Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) During the Up-titration Period
|
-1.14 seizures per week
Interval -4.63 to -0.5
|
SECONDARY outcome
Timeframe: Week 13 to Week 15, compared to Baseline Period (Week 1 to Week 4)Population: 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.
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).
Outcome measures
| Measure |
Seletracetam
n=27 Participants
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.
|
|---|---|
|
Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) Overall in the Down-titration Period
|
-0.96 seizures per week
Interval -3.0 to 1.41
|
SECONDARY outcome
Timeframe: Week 5 to Week 12, compared to Baseline Period (Week 1 to Week 4)Population: 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.
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).
Outcome measures
| Measure |
Seletracetam
n=31 Participants
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.
|
|---|---|
|
Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II +III) Overall in the Up-titration Period
|
-1.14 seizures per week
Interval -4.63 to -0.5
|
SECONDARY outcome
Timeframe: Week 5 to Week 15, compared to Baseline Period (Week 1 to Week 4)Population: 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.
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).
Outcome measures
| Measure |
Seletracetam
n=31 Participants
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.
|
|---|---|
|
Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period (Up-titration + Down-titration)
Visit 4 (Week 5 and 6)
|
-1.25 seizures per week
Interval -3.0 to 0.43
|
|
Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period (Up-titration + Down-titration)
Visit 5 (Week 7 and 8)
|
-1.39 seizures per week
Interval -4.5 to -0.25
|
|
Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period (Up-titration + Down-titration)
Visit 6 (Week 9 and 10)
|
-1.25 seizures per week
Interval -5.0 to -0.45
|
|
Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period (Up-titration + Down-titration)
Visit 7 (Week 11 and 12)
|
-1.94 seizures per week
Interval -4.2 to -0.57
|
|
Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period (Up-titration + Down-titration)
Visit 8 (Week 13)
|
-1.60 seizures per week
Interval -4.75 to -0.24
|
|
Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period (Up-titration + Down-titration)
Visit 9 (Week 14)
|
-1.25 seizures per week
Interval -3.23 to 1.0
|
|
Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period (Up-titration + Down-titration)
Visit 10 (Week 15)
|
-1.50 seizures per week
Interval -3.52 to 1.62
|
SECONDARY outcome
Timeframe: Week 5 to Week 15, compared to Baseline Period (Week 1 to Week 4)Population: 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.
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).
Outcome measures
| Measure |
Seletracetam
n=31 Participants
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.
|
|---|---|
|
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)
Visit 4 (Week 5 and 6)
|
-1.25 seizures per week
Interval -3.0 to 0.43
|
|
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)
Visit 5 (Week 7 and 8)
|
-1.39 seizures per week
Interval -4.5 to -0.25
|
|
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)
Visit 6 (Week 9 and 10)
|
-1.25 seizures per week
Interval -5.0 to -0.45
|
|
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)
Visit 7 (Week 11 and 12)
|
-1.94 seizures per week
Interval -4.2 to -0.57
|
|
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)
Visit 8 (Week 13)
|
-1.60 seizures per week
Interval -4.75 to -0.24
|
|
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)
Visit 9 (Week 14)
|
-1.25 seizures per week
Interval -3.23 to 1.0
|
|
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)
Visit 10 (Week 15)
|
-1.50 seizures per week
Interval -3.52 to 1.62
|
Adverse Events
Seletracetam
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Seletracetam
n=31 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Sinus bradycardia
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Ear and labyrinth disorders
Motion sickness
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Ear and labyrinth disorders
Tinnitus
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Eye disorders
Eye irritation
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Gastrointestinal disorders
Abdominal pain lower
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Gastrointestinal disorders
Abdominal tenderness
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Gastrointestinal disorders
Constipation
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Gastrointestinal disorders
Diarrhoea
|
9.7%
3/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Gastrointestinal disorders
Nausea
|
16.1%
5/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Gastrointestinal disorders
Stomach discomfort
|
6.5%
2/31 • Adverse events were collected from Week 1 up to Week 17
|
|
General disorders
Asthenia
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
General disorders
Energy increased
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
General disorders
Fatigue
|
6.5%
2/31 • Adverse events were collected from Week 1 up to Week 17
|
|
General disorders
Gait disturbance
|
6.5%
2/31 • Adverse events were collected from Week 1 up to Week 17
|
|
General disorders
Irritability
|
6.5%
2/31 • Adverse events were collected from Week 1 up to Week 17
|
|
General disorders
Pyrexia
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
General disorders
Tenderness
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Immune system disorders
Multiple allergies
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Infections and infestations
Ear infection
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Infections and infestations
Nasopharyngitis
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Infections and infestations
Rhinitis
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Infections and infestations
Upper respiratory tract infection
|
9.7%
3/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Infections and infestations
Urinary tract infection
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Infections and infestations
Vaginal infection
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Infections and infestations
Viral infection
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Injury, poisoning and procedural complications
Anticonvulsant toxicity
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Injury, poisoning and procedural complications
Chest injury
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Injury, poisoning and procedural complications
Contusion
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Injury, poisoning and procedural complications
Fall
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Injury, poisoning and procedural complications
Scratch
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Injury, poisoning and procedural complications
Tongue injury
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Injury, poisoning and procedural complications
Tooth injury
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Investigations
Alanine aminotransferase increased
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Investigations
Aspartate aminotransferase increased
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Investigations
Blood creatine phosphokinase increased
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Investigations
Blood thyroid stimulating hormone increased
|
6.5%
2/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Investigations
Liver function test abnormal
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Investigations
Platelet count decreased
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Investigations
Positive Rombergism
|
6.5%
2/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Investigations
Red blood cell morphology abnormal
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Investigations
Urine analysis abnormal
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Metabolism and nutrition disorders
Anorexia
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.7%
3/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.5%
2/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Nervous system disorders
Convulsion
|
6.5%
2/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Nervous system disorders
Coordination abnormal
|
6.5%
2/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Nervous system disorders
Dizziness
|
22.6%
7/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Nervous system disorders
Headache
|
12.9%
4/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Nervous system disorders
Hypersomnia
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Nervous system disorders
Migraine
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Nervous system disorders
Nystagmus
|
6.5%
2/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Nervous system disorders
Sensory disturbance
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Nervous system disorders
Sinus headache
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Nervous system disorders
Somnolence
|
32.3%
10/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Nervous system disorders
Tremor
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Psychiatric disorders
Anxiety
|
9.7%
3/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Psychiatric disorders
Confusional state
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Psychiatric disorders
Crying
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Psychiatric disorders
Depressed mood
|
12.9%
4/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Psychiatric disorders
Depression
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Psychiatric disorders
Emotional disorder
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Psychiatric disorders
Insomnia
|
6.5%
2/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Psychiatric disorders
Nervousness
|
6.5%
2/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Psychiatric disorders
Paranoia
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.5%
2/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
6.5%
2/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Skin and subcutaneous tissue disorders
Blister
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.2%
1/31 • Adverse events were collected from Week 1 up to Week 17
|
|
Vascular disorders
Poor venous access
|
6.5%
2/31 • Adverse events were collected from Week 1 up to Week 17
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60