Epilepsy, Partial
Conditions
Keywords
Epilepsy, Partial onset seizures, Seletracetam
Brief summary
This trial will evaluate the efficacy and safety of ucb 44212 as add on therapy in subjects with focal epilepsy.
Interventions
* Pharmaceutical form: oral capsules * Concentration: 10 and 50 mg * Route of administration: oral administration
Sponsors
UCB S.A. - Pharma Sector
Study design
Allocation
NA
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 Antiepileptic Drug (AEDs) * Female subjects without childbearing potential; Female subjects with childbearing potential are eligible if they use a medically accepted non-hormonal 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 * Subjects currently taking levetiracetam (LEV) * 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 |
|---|---|---|
| Percentage Change From Baseline in Seizure Frequency Per Week of Partial Onset Seizures (Type I) During the Up-titration Period | During the Up-titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| Percentage Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Overall in the Down-titration Period | During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4) | 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). |
| 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) | 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 Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in the Up-titration Period | During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4) | 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). |
| Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment 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. |
| Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Treatment 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). |
| Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Up-titration Period | During the Up-Titration Period (Week 5 to Week 12) | 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). |
| Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Down-titration Period | During the Down-Titration Period (Week 13 to Week 15) | 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). |
| Seizure Frequency Per Week for All Seizure Types (Type I+II+III) by Visit Over the Treatment 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. |
| Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Treatment 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). |
| Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in the Down-titration Period | During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4) | 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). |
| Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Down-titration Period | During the Down-Titration Period (Week 13 to Week 15) | 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). |
| Responder Rate in Partial Onset Seizures (Type I) Over the Up-titration Period | 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. |
| Percentage of Participants With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period | Week 12, compared to Baseline Period (Week 1 to Week 4) | Categories of percentage change in seizures from Baseline were as following: \< -25%; -25% to \<25%; 25% to \<75%; 75% to \<100%; 100%. |
| Percentage Change From Baseline in Seizure-free Days Per Week Over 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. |
| Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Overall in the Down-titration Period | During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4) | 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). |
| Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) During the Up-titration Period | Week 5 to Week 12, compared to Baseline Period (Week 1 to Week 4) | 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). |
| Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) Overall in the Down-titration Period | Week 13 to Week 15, compared to Baseline Period (Week 1 to Week 4) | 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). |
| Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II +III) Overall in the Up-titration Period | Week 5 to Week 12, compared to Baseline Period (Week 1 to Week 4) | 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). |
| Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period (Up-titration + Down-titration) | Week 5 to Week 15, compared to Baseline Period (Week 1 to Week 4) | 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). |
| 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) | Week 5 to Week 15, compared to Baseline Period (Week 1 to Week 4) | 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). |
| Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Up-titration Period | During the Up-Titration Period (Week 5 to Week 12) | 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). |
Countries
United States
Participant flow
Recruitment details
The study started to enroll patients in May 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. | 31 |
| Total | 31 |
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 | 31 Participants |
| Age, Continuous | 44.41 years STANDARD_DEVIATION 10.15 |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 27 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
Primary
Percentage Change From Baseline in Seizure Frequency Per Week of Partial Onset Seizures (Type I) During the Up-titration Period
Calculated as (7-day seizure frequency during the up-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Seletracetam | 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 |
Secondary
Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) by Visit Over the Treatment Period (Up-titration + Down-titration)
Calculated as (7-day seizure frequency during the treatment period for visit n) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). The treatment period referred to includes the period from the previous visit n-1 up to but not including the specific visit n. A negative value in change from Baseline indicates a decrease in all seizure types frequency from Baseline. The Overall Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15).
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
Secondary
Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) Overall in the Down-titration Period
Calculated as (7-day seizure frequency during the down-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). A negative value in change from Baseline indicates a decrease in all seizure types frequency from Baseline. The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Seletracetam | 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 |
Secondary
Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II +III) Overall in the Up-titration Period
Calculated as (7-day seizure frequency during the up-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). A negative value in change from Baseline indicates a decrease in all seizure types frequency from Baseline. The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Seletracetam | 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 |
Secondary
Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period (Up-titration + Down-titration)
Calculated as (7-day seizure frequency during the treatment period for visit n) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). The treatment period referred to includes the period from the previous visit n-1 up to but not including the specific visit n. A negative value in change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The Overall Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15).
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
Secondary
Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) During the Up-titration Period
Calculated as (7-day seizure frequency during the up-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). A negative value in change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Seletracetam | Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) During the Up-titration Period | -1.14 seizures per week |
Secondary
Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Overall in the Down-titration Period
Calculated as (7-day seizure frequency during the down-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). A negative value in change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Seletracetam | 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 |
Secondary
Percentage Change From Baseline in Seizure-free Days Per Week Over the Up-titration Period
A day was considered seizure-free, if no seizure was reported during 24 hours.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Seletracetam | Percentage Change From Baseline in Seizure-free Days Per Week Over the Up-titration Period | 13.80 percentage of change |
Secondary
Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) by Visit Over the Treatment Period (Up-titration + Down-titration)
Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in seizure frequency from Baseline. The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
Secondary
Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in the Down-titration Period
Calculated as (7-day seizure frequency during the down-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in seizure frequency from Baseline. The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Seletracetam | 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 |
Secondary
Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in the Up-titration Period
Calculated as (7-day seizure frequency during the up-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in seizure frequency from Baseline. The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Seletracetam | 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 |
Secondary
Percentage Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Overall in the Down-titration Period
Calculated as (7-day seizure frequency during the down-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Seletracetam | 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 |
Secondary
Percentage Change From Baseline in Seizure Frequency Per Week of Partial Onset Seizures (Type I) by Visit Over the Treatment Period (Up-titration + Down-titration)
Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
Secondary
Percentage of Participants With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period
Categories of percentage change in seizures from Baseline were as following: \< -25%; -25% to \<25%; 25% to \<75%; 75% to \<100%; 100%.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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
Responder Rate in Partial Onset Seizures (Type I) Over the Up-titration Period
A responder was defined as a subject with a \>= 50% reduction in seizure frequency per week from the Baseline Period (Week 1 to Week 4) to the end of the Up-Titration Period.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Seletracetam | Responder Rate in Partial Onset Seizures (Type I) Over the Up-titration Period | 25.8 percentage of participants |
Secondary
Seizure Frequency Per Week for All Seizure Types (Type I+II+III) by Visit Over the Treatment Period
Calculated as 7-day seizure frequency for all seizure types (type I+II+III). The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
Secondary
Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Down-titration Period
Calculated as 7-day seizure frequency for all seizure types (type I+II+III). The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Seletracetam | Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Down-titration Period | 3.50 seizures per week |
Secondary
Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Treatment Period
Calculated as 7-day seizure frequency for all seizure types (type I+II+III). The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15).
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Seletracetam | Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Treatment Period | 2.74 seizures per week |
Secondary
Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Up-titration Period
Calculated as 7-day seizure frequency for all seizure types (type I+II+III). The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Seletracetam | Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Up-titration Period | 2.25 seizures per week |
Secondary
Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period
Calculated as 7-day partial onset seizure (type I) frequency; The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
| Seletracetam | 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 |
Secondary
Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Down-titration Period
Calculated as 7-day partial onset seizure (type I) frequency. The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Seletracetam | Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Down-titration Period | 3.50 seizures per week |
Secondary
Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Treatment Period
Calculated as 7-day partial onset seizure (type I) frequency. The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15).
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Seletracetam | Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Treatment Period | 2.74 seizures per week |
Secondary
Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Up-titration Period
Calculated as 7-day partial onset seizure (type I) frequency. The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Seletracetam | Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Up-titration Period | 2.25 seizures per week |