Epilepsy, Partial
Conditions
Keywords
Epilepsy, Partial Onset Seizures, Seletracetam, Levetiracetam
Brief summary
This trial will evaluate the efficacy and safety of UCB44212 as add-on therapy in subjects with focal epilepsy.
Interventions
DRUGSeletracetam (UCB44212)
* Pharmaceutical form: oral capsules * Concentration: 2, 10 and 50 mg * Route of administration: oral administration
Sponsors
UCB Pharma SA
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Males/Females from 18 to 65 years of age (minimum body weight of 40 kg) * Subjects with a confirmed diagnosis of epilepsy suffering from partial onset seizures whether or not secondarily generalized * Subjects who have been treated for epilepsy for \>= 6 months and are currently uncontrolled while being treated with 1-3 concomitant AED(s), inclusive of levetiracetam (LEV) * Female subjects without childbearing potential or those who are using an acceptable contraceptive method
Exclusion criteria
* Seizures occurring in clusters. Status epilepticus within 6 months of Visit 1. History of non-epileptic seizures * Subjects on vigabatrin * Subjects on felbamate, unless treatment has been continuous for \>2 years * Ongoing psychiatric disease other than mild controlled disorders * Subjects with clinically significant organ dysfunction * Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients * Pregnant or lactating women * Use of benzodiazepines (for any indication) taken at a higher frequency than an average of once a week, unless counted as one of the concomitant Antiepileptic Drug (AEDs).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period | During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period | During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4) | 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. |
| Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period | During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4) | 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. |
| Seizure Frequency Per Week (Type I) by Visit Over the Treatment Period and Overall by Period | During the Treatment Period (Week 5 to Week 15) | 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. |
| Percent Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period | During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4) | 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. |
| Percentage of Responder Subjects in Partial Onset Seizures (Type I) Over the Up-titration Period | During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4) | 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. |
| Categorized Percentage Response to Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period | During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4) | 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%. |
| Percent Change From Baseline in Seizure-free Days Per Week Over the Up-titration Period | During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4) | 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). |
| Seizure Frequency Per Week (Type I+II+III) by Visit Over the Treatment Period and Overall by Period | During the Treatment Period (Week 5 to Week 15) | 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. |
Countries
Canada, United States
Participant flow
Recruitment details
The study started to enroll patients in August 2005 and concluded in May 2006.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 59 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
Baseline characteristics
| Characteristic | Seletracetam |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 59 Participants |
| Age, Continuous | 40.34 years STANDARD_DEVIATION 10.49 |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 59 |
| other Total, other adverse events | 44 / 59 |
| serious Total, serious adverse events | 2 / 59 |
Outcome results
Primary
Percent Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
Secondary
Categorized Percentage Response to Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period
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%.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Seletracetam | Categorized Percentage Response to Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period | < -25% | 12.5 percentage of participants |
| Seletracetam | Categorized Percentage Response to Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period | -25% to < 25% | 25.0 percentage of participants |
| Seletracetam | Categorized Percentage Response to Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period | 25% to < 75% | 57.1 percentage of participants |
| Seletracetam | 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
Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
Secondary
Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
Secondary
Percentage of Responder Subjects 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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Seletracetam | Percentage of Responder Subjects in Partial Onset Seizures (Type I) Over the Up-titration Period | 28.6 percentage of participants |
Secondary
Percent 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. A positive value indicates improvement from Baseline (Week 1 to Week 4).
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Seletracetam | Percent Change From Baseline in Seizure-free Days Per Week Over the Up-titration Period | 11.45 percentage of change |
Secondary
Percent Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
Secondary
Seizure Frequency Per Week (Type I) by Visit Over the Treatment Period and Overall by 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
Secondary
Seizure Frequency Per Week (Type I+II+III) by Visit Over the Treatment Period and Overall by 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |