Trial Outcomes & Findings for Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam (NCT NCT00152503)
NCT ID: NCT00152503
Last Updated: 2023-09-07
Results Overview
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.
COMPLETED
PHASE2
59 participants
During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)
2023-09-07
Participant Flow
The study started to enroll patients in August 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
|
59
|
|
Overall Study
COMPLETED
|
55
|
|
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 Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam
Baseline characteristics by cohort
| Measure |
Seletracetam
n=59 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
|
59 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
40.34 years
STANDARD_DEVIATION 10.49 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)Population: 59 subjects were included in the ITT-set, who took at least one dose of trial medication. Only subjects with available data for the respective visit/ period are included in the analysis. Number of subjects analyzed is given separately for each visit/ period.
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=59 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.
|
|---|---|
|
Percent Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
Visit 6 (Week 9 and 10)
|
-42.22 percentage of change
Interval -66.67 to -25.0
|
|
Percent Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
Visit 7 (Week 11 and 12)
|
-31.67 percentage of change
Interval -79.0 to 9.02
|
|
Percent Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
Visit 4 (Week 5 and 6)
|
-26.07 percentage of change
Interval -49.29 to -5.88
|
|
Percent Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
Visit 5 (Week 7 and 8)
|
-32.05 percentage of change
Interval -52.6 to -8.46
|
|
Percent Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
Up-titration (Weeks 5 to 12)
|
-34.01 percentage of change
Interval -50.69 to -13.27
|
|
Percent Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
Visit 8 (Week 13)
|
-44.44 percentage of change
Interval -74.6 to -10.0
|
|
Percent Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
Visit 9 (Week 14)
|
-22.22 percentage of change
Interval -55.56 to 12.5
|
|
Percent Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
Visit 10 (Week 15)
|
-33.85 percentage of change
Interval -61.79 to 35.0
|
|
Percent Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
Down-titration (Weeks 13 to 15)
|
-29.29 percentage of change
Interval -51.05 to 6.06
|
|
Percent Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
On Treatment (Weeks 5 to 15)
|
-33.09 percentage of change
Interval -47.38 to -13.2
|
SECONDARY outcome
Timeframe: During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)Population: 59 subjects were included in the ITT-set, who took at least one dose of trial medication. Only subjects with available data for the respective visit/ period are included in the analysis. Number of subjects analyzed is given separately for each visit/ period.
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=59 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.
|
|---|---|
|
Percent Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period
Visit 6 (Week 9 and 10)
|
-42.22 percentage of change
Interval -66.67 to -25.0
|
|
Percent Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period
Visit 4 (Week 5 and 6)
|
-26.07 percentage of change
Interval -49.29 to -5.88
|
|
Percent Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period
Visit 5 (Week 7 and 8)
|
-32.05 percentage of change
Interval -52.6 to -8.46
|
|
Percent Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period
Visit 7 (Week 11 and 12)
|
-31.67 percentage of change
Interval -79.0 to 9.02
|
|
Percent Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period
Up-titration (Weeks 5 to 12)
|
-34.01 percentage of change
Interval -50.69 to -13.27
|
|
Percent Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period
Visit 8 (Week 13)
|
-44.44 percentage of change
Interval -74.6 to -10.0
|
|
Percent Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period
Visit 9 (Week 14)
|
-22.22 percentage of change
Interval -55.56 to 12.5
|
|
Percent Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period
Visit 10 (Week 15)
|
-33.85 percentage of change
Interval -61.79 to 35.0
|
|
Percent Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period
Down-Titration (Weeks 13 to 15)
|
-29.29 percentage of change
Interval -51.05 to 6.06
|
|
Percent Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period
On Treatment (Weeks 5 to 15)
|
-33.09 percentage of change
Interval -47.38 to -13.2
|
SECONDARY outcome
Timeframe: During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)Population: 59 subjects were included in the ITT-set, who took at least one dose of trial medication. Only subjects with available data for the respective visit/ period are included in the analysis. Number of subjects analyzed is given separately for each visit/ period.
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=59 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 and Overall by Period
Visit 7 (Week 11 and 12)
|
-1.31 seizures per week
Interval -3.13 to 0.27
|
|
Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
Up-titration (Weeks 5 to 12)
|
-1.36 seizures per week
Interval -2.77 to -0.56
|
|
Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
Visit 4 (Week 5 and 6)
|
-0.85 seizures per week
Interval -2.92 to -0.17
|
|
Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
Visit 5 (Week 7 and 8)
|
-1.25 seizures per week
Interval -3.22 to -0.39
|
|
Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
Visit 6 (Week 9 and 10)
|
-1.83 seizures per week
Interval -3.13 to -0.68
|
|
Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
Visit 8 (Week 13)
|
-1.68 seizures per week
Interval -3.63 to -0.31
|
|
Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
Visit 9 (Week 14)
|
-1.00 seizures per week
Interval -2.63 to 0.48
|
|
Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
Visit 10 (Week 15)
|
-1.14 seizures per week
Interval -3.11 to 1.38
|
|
Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
Down-Titration (Weeks 13 to 15)
|
-1.09 seizures per week
Interval -2.3 to 0.25
|
|
Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
On Treatment (Weeks 5 to 15)
|
-1.13 seizures per week
Interval -2.62 to -0.49
|
SECONDARY outcome
Timeframe: During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)Population: 59 subjects were included in the ITT-set, who took at least one dose of trial medication. Only subjects with available data for the respective visit/ period are included in the analysis. Number of subjects analyzed is given separately for each visit/ period.
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=59 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 and Overall by Period
Visit 9 (Week 14)
|
-1.00 seizures per week
Interval -2.63 to 0.48
|
|
Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period
Visit 10 (Week 15)
|
-1.14 seizures per week
Interval -3.11 to 1.38
|
|
Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period
On Treatment (Weeks 5 to 15)
|
-1.13 seizures per week
Interval -2.62 to -0.49
|
|
Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period
Visit 4 (Week 5 and 6)
|
-0.85 seizures per week
Interval -2.92 to -0.17
|
|
Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period
Visit 5 (Week 7 and 8)
|
-1.25 seizures per week
Interval -3.22 to -0.39
|
|
Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period
Visit 6 (Week 9 and 10)
|
-1.83 seizures per week
Interval -3.13 to -0.68
|
|
Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period
Visit 7 (Week 11 and 12)
|
-1.31 seizures per week
Interval -3.13 to 0.27
|
|
Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period
Up-titration (Weeks 5 to 12)
|
-1.36 seizures per week
Interval -2.77 to -0.56
|
|
Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period
Visit 8 (Week 13)
|
-1.68 seizures per week
Interval -3.63 to -0.31
|
|
Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period
Down-Titration (Weeks 13 to 15)
|
-1.09 seizures per week
Interval -2.3 to 0.25
|
SECONDARY outcome
Timeframe: During the Treatment Period (Week 5 to Week 15)Population: 59 subjects were included in the ITT-set, who took at least one dose of trial medication. Only subjects with available data for the respective visit/ period are included in the analysis. Number of subjects analyzed is given separately for each visit/ 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.
Outcome measures
| Measure |
Seletracetam
n=59 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 (Type I) by Visit Over the Treatment Period and Overall by Period
Baseline (Week 1 to Week 4)
|
3.63 seizure frequency per week
Interval 2.42 to 7.5
|
|
Seizure Frequency Per Week (Type I) by Visit Over the Treatment Period and Overall by Period
Visit 4 (Week 5 and 6)
|
3.25 seizure frequency per week
Interval 1.57 to 5.96
|
|
Seizure Frequency Per Week (Type I) by Visit Over the Treatment Period and Overall by Period
Visit 5 (Week 7 and 8)
|
2.90 seizure frequency per week
Interval 1.5 to 5.19
|
|
Seizure Frequency Per Week (Type I) by Visit Over the Treatment Period and Overall by Period
Visit 6 (Week 9 and 10)
|
2.15 seizure frequency per week
Interval 1.08 to 8.4
|
|
Seizure Frequency Per Week (Type I) by Visit Over the Treatment Period and Overall by Period
Visit 7 (Week 11 and 12)
|
2.27 seizure frequency per week
Interval 0.74 to 5.67
|
|
Seizure Frequency Per Week (Type I) by Visit Over the Treatment Period and Overall by Period
Up-titration (Weeks 5 to 12)
|
2.71 seizure frequency per week
Interval 1.56 to 6.4
|
|
Seizure Frequency Per Week (Type I) by Visit Over the Treatment Period and Overall by Period
Visit 8 (Week 13)
|
2.63 seizure frequency per week
Interval 1.0 to 5.0
|
|
Seizure Frequency Per Week (Type I) by Visit Over the Treatment Period and Overall by Period
Visit 9 (Week 14)
|
3.00 seizure frequency per week
Interval 1.17 to 9.0
|
|
Seizure Frequency Per Week (Type I) by Visit Over the Treatment Period and Overall by Period
Visit 10 (Week 15)
|
3.50 seizure frequency per week
Interval 1.4 to 8.75
|
|
Seizure Frequency Per Week (Type I) by Visit Over the Treatment Period and Overall by Period
Down-Titration (Weeks 13 to 15)
|
3.18 seizure frequency per week
Interval 1.59 to 7.0
|
|
Seizure Frequency Per Week (Type I) by Visit Over the Treatment Period and Overall by Period
On Treatment (Weeks 5 to 15)
|
3.02 seizure frequency per week
Interval 1.67 to 6.2
|
SECONDARY outcome
Timeframe: During the Treatment Period (Week 5 to Week 15)Population: 59 subjects were included in the ITT-set, who took at least one dose of trial medication. Only subjects with available data for the respective visit/ period are included in the analysis. Number of subjects analyzed is given separately for each visit/ 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.
Outcome measures
| Measure |
Seletracetam
n=59 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 (Type I+II+III) by Visit Over the Treatment Period and Overall by Period
Baseline (Week 1 to Week 4)
|
3.63 seizure frequency per week
Interval 2.42 to 7.5
|
|
Seizure Frequency Per Week (Type I+II+III) by Visit Over the Treatment Period and Overall by Period
Visit 4 (Week 5 and 6)
|
3.25 seizure frequency per week
Interval 1.57 to 5.96
|
|
Seizure Frequency Per Week (Type I+II+III) by Visit Over the Treatment Period and Overall by Period
Visit 5 (Week 7 and 8)
|
2.90 seizure frequency per week
Interval 1.5 to 5.19
|
|
Seizure Frequency Per Week (Type I+II+III) by Visit Over the Treatment Period and Overall by Period
Visit 6 (Week 9 and 10)
|
2.15 seizure frequency per week
Interval 1.08 to 8.4
|
|
Seizure Frequency Per Week (Type I+II+III) by Visit Over the Treatment Period and Overall by Period
Visit 7 (Week 11 and 12)
|
2.27 seizure frequency per week
Interval 0.74 to 5.67
|
|
Seizure Frequency Per Week (Type I+II+III) by Visit Over the Treatment Period and Overall by Period
Up-titration (Weeks 5 to 12)
|
2.71 seizure frequency per week
Interval 1.56 to 6.4
|
|
Seizure Frequency Per Week (Type I+II+III) by Visit Over the Treatment Period and Overall by Period
Visit 8 (Week 13)
|
2.63 seizure frequency per week
Interval 1.0 to 5.0
|
|
Seizure Frequency Per Week (Type I+II+III) by Visit Over the Treatment Period and Overall by Period
Visit 9 (Week 14)
|
3.00 seizure frequency per week
Interval 1.17 to 9.0
|
|
Seizure Frequency Per Week (Type I+II+III) by Visit Over the Treatment Period and Overall by Period
Visit 10 (Week 15)
|
3.50 seizure frequency per week
Interval 1.4 to 8.75
|
|
Seizure Frequency Per Week (Type I+II+III) by Visit Over the Treatment Period and Overall by Period
On Treatment (Weeks 5 to 15)
|
3.02 seizure frequency per week
Interval 1.67 to 6.2
|
|
Seizure Frequency Per Week (Type I+II+III) by Visit Over the Treatment Period and Overall by Period
Down-Titration (Weeks 13 to 15)
|
3.18 seizure frequency per week
Interval 1.59 to 7.0
|
SECONDARY outcome
Timeframe: During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)Population: 59 subjects were included in the ITT-set, who took at least one dose of trial medication. Only subjects with available post-baseline seizure data are included in the analysis.
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=56 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 Responder Subjects in Partial Onset Seizures (Type I) Over the Up-titration Period
|
28.6 percentage of participants
|
SECONDARY outcome
Timeframe: During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)Population: 59 subjects were included in the ITT-set, who took at least one dose of trial medication. Only subjects with available post-baseline seizure data are included in the analysis.
Response to treatment in partial onset seizures (type I) over the up-titration period were analyzed by the percentage change from baseline (Week 1 to Week 4) in partial seizure frequency per week over the up-titration period, grouped in 4 categories: \<-25%, -25% to \<25%, 25% to \<75%, and 75% to 100%.
Outcome measures
| Measure |
Seletracetam
n=56 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.
|
|---|---|
|
Categorized Percentage Response to Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period
< -25%
|
12.5 percentage of participants
|
|
Categorized Percentage Response to Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period
-25% to < 25%
|
25.0 percentage of participants
|
|
Categorized Percentage Response to Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period
25% to < 75%
|
57.1 percentage of participants
|
|
Categorized Percentage Response to Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period
75% to <100%
|
5.4 percentage of participants
|
SECONDARY outcome
Timeframe: During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)Population: 59 subjects were included in the ITT-set, who took at least one dose of trial medication. Only subjects with available post-baseline seizure data are included in the analysis.
A day was considered seizure-free, if no seizure was reported during 24 hours. A positive value indicates improvement from Baseline (Week 1 to Week 4).
Outcome measures
| Measure |
Seletracetam
n=52 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.
|
|---|---|
|
Percent Change From Baseline in Seizure-free Days Per Week Over the Up-titration Period
|
11.45 percentage of change
Interval 1.45 to 28.99
|
Adverse Events
Seletracetam
Serious adverse events
| Measure |
Seletracetam
n=59 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
Angina unstable
|
1.7%
1/59 • Adverse events were collected from Baseline to Follow-Up visit (up to Week 17).
Adverse Events refer to the Intention-To-Treat (ITT) population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
1.7%
1/59 • Adverse events were collected from Baseline to Follow-Up visit (up to Week 17).
Adverse Events refer to the Intention-To-Treat (ITT) population.
|
|
Nervous system disorders
Convulsion
|
1.7%
1/59 • Adverse events were collected from Baseline to Follow-Up visit (up to Week 17).
Adverse Events refer to the Intention-To-Treat (ITT) population.
|
Other adverse events
| Measure |
Seletracetam
n=59 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.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.8%
4/59 • Adverse events were collected from Baseline to Follow-Up visit (up to Week 17).
Adverse Events refer to the Intention-To-Treat (ITT) population.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.8%
4/59 • Adverse events were collected from Baseline to Follow-Up visit (up to Week 17).
Adverse Events refer to the Intention-To-Treat (ITT) population.
|
|
Gastrointestinal disorders
Nausea
|
20.3%
12/59 • Adverse events were collected from Baseline to Follow-Up visit (up to Week 17).
Adverse Events refer to the Intention-To-Treat (ITT) population.
|
|
Gastrointestinal disorders
Vomiting
|
10.2%
6/59 • Adverse events were collected from Baseline to Follow-Up visit (up to Week 17).
Adverse Events refer to the Intention-To-Treat (ITT) population.
|
|
General disorders
Fatigue
|
13.6%
8/59 • Adverse events were collected from Baseline to Follow-Up visit (up to Week 17).
Adverse Events refer to the Intention-To-Treat (ITT) population.
|
|
General disorders
Irritability
|
5.1%
3/59 • Adverse events were collected from Baseline to Follow-Up visit (up to Week 17).
Adverse Events refer to the Intention-To-Treat (ITT) population.
|
|
Infections and infestations
Bronchitis
|
5.1%
3/59 • Adverse events were collected from Baseline to Follow-Up visit (up to Week 17).
Adverse Events refer to the Intention-To-Treat (ITT) population.
|
|
Infections and infestations
Herpes simplex
|
5.1%
3/59 • Adverse events were collected from Baseline to Follow-Up visit (up to Week 17).
Adverse Events refer to the Intention-To-Treat (ITT) population.
|
|
Infections and infestations
Nasopharyngitis
|
11.9%
7/59 • Adverse events were collected from Baseline to Follow-Up visit (up to Week 17).
Adverse Events refer to the Intention-To-Treat (ITT) population.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.2%
6/59 • Adverse events were collected from Baseline to Follow-Up visit (up to Week 17).
Adverse Events refer to the Intention-To-Treat (ITT) population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.1%
3/59 • Adverse events were collected from Baseline to Follow-Up visit (up to Week 17).
Adverse Events refer to the Intention-To-Treat (ITT) population.
|
|
Nervous system disorders
Convulsion
|
5.1%
3/59 • Adverse events were collected from Baseline to Follow-Up visit (up to Week 17).
Adverse Events refer to the Intention-To-Treat (ITT) population.
|
|
Nervous system disorders
Dizziness
|
22.0%
13/59 • Adverse events were collected from Baseline to Follow-Up visit (up to Week 17).
Adverse Events refer to the Intention-To-Treat (ITT) population.
|
|
Nervous system disorders
Headache
|
15.3%
9/59 • Adverse events were collected from Baseline to Follow-Up visit (up to Week 17).
Adverse Events refer to the Intention-To-Treat (ITT) population.
|
|
Nervous system disorders
Nystagmus
|
6.8%
4/59 • Adverse events were collected from Baseline to Follow-Up visit (up to Week 17).
Adverse Events refer to the Intention-To-Treat (ITT) population.
|
|
Nervous system disorders
Somnolence
|
13.6%
8/59 • Adverse events were collected from Baseline to Follow-Up visit (up to Week 17).
Adverse Events refer to the Intention-To-Treat (ITT) population.
|
|
Nervous system disorders
Tremor
|
5.1%
3/59 • Adverse events were collected from Baseline to Follow-Up visit (up to Week 17).
Adverse Events refer to the Intention-To-Treat (ITT) population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.5%
5/59 • Adverse events were collected from Baseline to Follow-Up visit (up to Week 17).
Adverse Events refer to the Intention-To-Treat (ITT) population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.1%
3/59 • Adverse events were collected from Baseline to Follow-Up visit (up to Week 17).
Adverse Events refer to the Intention-To-Treat (ITT) population.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
6.8%
4/59 • Adverse events were collected from Baseline to Follow-Up visit (up to Week 17).
Adverse Events refer to the Intention-To-Treat (ITT) population.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.1%
3/59 • Adverse events were collected from Baseline to Follow-Up visit (up to Week 17).
Adverse Events refer to the Intention-To-Treat (ITT) population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60