Epilepsy, Partial
Conditions
Keywords
Epilepsy, partial, Keppra, Levetiracetam
Brief summary
The safety and efficacy of L059 was evaluated in patients who completed N165 Clinical Trial of L059. They received L059 at a daily dose from 1,000 mg to 3,000 mg in addition to their standard concomitant AEDs
Interventions
DRUGLevetiracetam
* Pharmaceutical form: Film-coating tablets * Concentration: 250 mg/ 500 mg * Route of administration: oral use
Sponsors
UCB Japan Co. Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study N01020 (NCT00160615) was designed as a single group assignment study and as follow-up study, open for patients from N165 (NCT00600509). The differentiation into placebo and Levetiracetam in the results reporting section is based on the treatment of the previously conducted study N165 (NCT00600509).
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who completed the evaluation period (Week 16) of N165 Clinical Trial of L059 * Patients/the parent or guardian wish to continue treatment with L059 and to enter N165 Follow-up Study, and also the investigator admit the necessity of the repeated intake of the investigational drug for the patients.
Exclusion criteria
* Patients who had not participate in N165 Clinical Trial of L059. * Patients who had participated in N165 Clinical Trial of L059 with no intention of entering the follow-up study taking the same medication. * Patients had not been in compliance with requirements of Protocol for N165 Clinical Trial of L059 in the course of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | From Baseline up to 54 months | Number of Partial (Type IC) seizures over the treatment period standardized to 1 week period. |
| Partial (Type I) Seizure Frequency Per Week by Analysis Visit | From Baseline up to 54 months | Number of Partial (Type I) seizures over the treatment period standardized to 1 week period. |
| Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | From Baseline up to 54 months | Number of Partial (Type IA) seizures over the treatment period standardized to 1 week period. |
| Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | From Baseline up to 54 months | Number of Partial (Type IB) seizures over the treatment period standardized to 1 week period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | From Baseline up to 54 months | Percentage change from baseline of of Partial (Type I) seizure frequency over the treatment period standardized to 1 week period. Negative values indicate improvement from Baseline. |
| Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | From Baseline up to 54 months | Percentage change from baseline of of Partial (Type IA) seizure frequency over the treatment period standardized to 1 week period. Negative values indicate improvement from Baseline. |
| Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | From Baseline up to 54 months | Percentage change from baseline of of Partial (Type IB) seizure frequency over the treatment period standardized to 1 week period. Negative values indicate improvement from Baseline. |
| Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | From Baseline up to 54 months | Percentage change from baseline of of Partial (Type IC) seizure frequency over the treatment period standardized to 1 week period. Negative values indicate improvement from Baseline. |
Participant flow
Recruitment details
The study started to enroll patients in September 2001 and concluded in January 2007.
Pre-assignment details
Participant Flow refers to the Full Analysis Set (FAS). Of the 154 subjects who enrolled in the study, 151 subjects were included in the FAS population and 3 subjects were identified with major protocol deviations leading to exclusion from FAS.
Participants by arm
| Arm | Count |
|---|---|
| N165 Randomized Treatment PBO (FAS) Subjects received Placebo (PBO) in study N165 \[NCT00600509\] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day. | 50 |
| N165 Randomized Treatment LEV (FAS) Subjects received Levetiracetam (LEV) in study N165 \[NCT00600509\] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day. | 101 |
| Total Title | 151 |
| Total | 302 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 12 |
| Overall Study | AE agents had to be discontinued (exam.) | 0 | 1 |
| Overall Study | Investigator decision | 1 | 1 |
| Overall Study | Lack of Efficacy | 11 | 23 |
| Overall Study | Non-compliance was suspected | 0 | 1 |
| Overall Study | Patient decision | 1 | 2 |
| Overall Study | Poor compliance | 0 | 1 |
| Overall Study | Switch to surgical treatment | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | N165 Randomized Treatment PBO (FAS) | N165 Randomized Treatment LEV (FAS) | Total Title |
|---|---|---|---|
| Age, Continuous | 33.19 Years STANDARD_DEVIATION 9.99 | 31.95 Years STANDARD_DEVIATION 10.19 | 32.36 Years STANDARD_DEVIATION 10.11 |
| Age, Customized <=18 years | 2 Participants | 6 Participants | 8 Participants |
| Age, Customized Between 18 and 65 years | 48 Participants | 95 Participants | 143 Participants |
| Sex: Female, Male Female | 27 Participants | 47 Participants | 74 Participants |
| Sex: Female, Male Male | 23 Participants | 54 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 1 / 101 |
| other Total, other adverse events | 48 / 50 | 99 / 101 |
| serious Total, serious adverse events | 12 / 50 | 22 / 101 |
Outcome results
Primary
Partial (Type IA) Seizure Frequency Per Week by Analysis Visit
Number of Partial (Type IA) seizures over the treatment period standardized to 1 week period.
Time frame: From Baseline up to 54 months
Population: Subjects with Type IA seizure count equal to zero during baseline and evaluation periods are excluded. Only subjects with valid data for partial (Type IA) 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) |
|---|---|---|---|
| N165 Randomized Treatment PBO | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 15 m - <= 18 m | 0.27 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment PBO | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 30 m - <= 33 m | 0.24 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment PBO | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 9 m - <= 12 m | 0.26 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment PBO | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 33 m - <= 36 m | 0.17 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment PBO | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 18 m - <= 21 m | 0.10 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment PBO | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 36 m - <= 39 m | 0.14 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment PBO | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 6 m - <= 9 m | 0.24 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment PBO | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 39 m - <= 42 m | 0.17 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment PBO | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 21 m - <= 24 m | 0.17 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment PBO | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 42 m - <= 45 m | 0.09 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment PBO | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 12 m - <= 15 m | 0.57 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment PBO | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 45 m - <= 48 m | 0.20 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment PBO | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 24 m - <= 27 m | 0.29 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment PBO | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 48 m - <= 51 m | 0.44 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment PBO | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 3 m - <= 6 m | 0.32 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment PBO | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 51 m - <= 54 m | 0.62 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment PBO | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 27 m - <= 30 m | 0.44 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment PBO | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 54 m | 0.87 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment PBO | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | >= 1 d - <= 3 m | 0.86 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment LEV | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 54 m | 0.08 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment LEV | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | >= 1 d - <= 3 m | 0.68 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment LEV | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 3 m - <= 6 m | 0.83 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment LEV | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 6 m - <= 9 m | 0.63 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment LEV | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 9 m - <= 12 m | 0.50 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment LEV | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 12 m - <= 15 m | 0.22 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment LEV | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 15 m - <= 18 m | 0.30 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment LEV | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 18 m - <= 21 m | 0.42 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment LEV | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 21 m - <= 24 m | 0.43 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment LEV | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 24 m - <= 27 m | 0.25 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment LEV | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 27 m - <= 30 m | 0.17 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment LEV | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 30 m - <= 33 m | 0.25 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment LEV | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 33 m - <= 36 m | 0.29 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment LEV | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 36 m - <= 39 m | 0.13 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment LEV | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 39 m - <= 42 m | 0.28 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment LEV | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 42 m - <= 45 m | 0.44 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment LEV | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 45 m - <= 48 m | 0.48 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment LEV | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 48 m - <= 51 m | 0.18 Number of Seizures (Type IA) per week |
| N165 Randomized Treatment LEV | Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | > 51 m - <= 54 m | 0.17 Number of Seizures (Type IA) per week |
Primary
Partial (Type IB) Seizure Frequency Per Week by Analysis Visit
Number of Partial (Type IB) seizures over the treatment period standardized to 1 week period.
Time frame: From Baseline up to 54 months
Population: Subjects with Type IB seizure count equal to zero during baseline and evaluation periods are excluded. Only subjects with valid data for partial (Type IB) 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) |
|---|---|---|---|
| N165 Randomized Treatment PBO | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 15 m - <= 18 m | 1.25 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment PBO | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 30 m - <= 33 m | 1.25 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment PBO | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 9 m - <= 12 m | 1.39 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment PBO | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 33 m - <= 36 m | 1.15 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment PBO | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 18 m - <= 21 m | 1.25 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment PBO | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 36 m - <= 39 m | 1.28 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment PBO | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 6 m <= 9 m | 1.30 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment PBO | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 39 m - <= 42 m | 1.40 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment PBO | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 21 m - <= 24 m | 1.26 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment PBO | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 42 m - <= 45 m | 1.22 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment PBO | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 12 m - <= 15 m | 1.34 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment PBO | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 45 m - <= 48 m | 0.87 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment PBO | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 24 m - <= 27 m | 1.21 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment PBO | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 48 m - <= 51 m | 0.74 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment PBO | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 3 m - <= 6 m | 1.51 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment PBO | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 51 m - <= 54 m | 0.80 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment PBO | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 27 m - <= 30 m | 1.21 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment PBO | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 54 m | 0.72 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment PBO | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | >= 1 d - <= 3 m | 1.56 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment LEV | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 54 m | 0.09 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment LEV | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | >= 1 d - <= 3 m | 1.27 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment LEV | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 3 m - <= 6 m | 1.13 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment LEV | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 6 m <= 9 m | 0.92 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment LEV | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 9 m - <= 12 m | 0.72 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment LEV | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 12 m - <= 15 m | 0.81 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment LEV | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 15 m - <= 18 m | 0.81 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment LEV | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 18 m - <= 21 m | 0.58 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment LEV | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 21 m - <= 24 m | 0.73 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment LEV | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 24 m - <= 27 m | 0.85 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment LEV | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 27 m - <= 30 m | 0.98 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment LEV | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 30 m - <= 33 m | 0.79 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment LEV | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 33 m - <= 36 m | 0.96 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment LEV | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 36 m - <= 39 m | 1.04 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment LEV | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 39 m - <= 42 m | 0.77 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment LEV | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 42 m - <= 45 m | 0.89 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment LEV | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 45 m - <= 48 m | 0.27 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment LEV | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 48 m - <= 51 m | 0.22 Number of Seizures (Type IB) per week |
| N165 Randomized Treatment LEV | Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | > 51 m - <= 54 m | 0.19 Number of Seizures (Type IB) per week |
Primary
Partial (Type IC) Seizure Frequency Per Week by Analysis Visit
Number of Partial (Type IC) seizures over the treatment period standardized to 1 week period.
Time frame: From Baseline up to 54 months
Population: Subjects with Type IC seizure count equal to zero during baseline and evaluation periods are excluded. Only subjects with valid data for partial (Type IC) 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) |
|---|---|---|---|
| N165 Randomized Treatment PBO | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 15 m - <= 18 m | 0.00 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment PBO | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 30 m - <= 33 m | 0.09 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment PBO | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 9 m - <= 12 m | 0.06 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment PBO | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 33 m - <= 36 m | 0.06 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment PBO | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 18 m - <= 21 m | 0.00 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment PBO | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 36 m - <= 39 m | 0.04 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment PBO | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 6 m - <= 9 m | 0.05 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment PBO | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 39 m - <= 42 m | 0.08 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment PBO | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 21 m - <= 24 m | 0.05 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment PBO | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 42 m - <= 45 m | 0.04 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment PBO | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 12 m - <= 15 m | 0.06 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment PBO | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 45 m - <= 48 m | 0.02 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment PBO | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 24 m - <= 27 m | 0.02 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment PBO | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 48 m - <= 51 m | 0.00 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment PBO | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 3 m - <= 6 m | 0.00 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment PBO | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 51 m - <= 54 m | 0.00 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment PBO | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 27 m - <= 30 m | 0.04 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment PBO | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 54 m | 0.00 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment PBO | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | >= 1 d - <= 3 m | 0.00 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment LEV | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 54 m | 0.00 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment LEV | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | >= 1 d - <= 3 m | 0.00 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment LEV | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 3 m - <= 6 m | 0.00 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment LEV | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 6 m - <= 9 m | 0.00 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment LEV | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 9 m - <= 12 m | 0.00 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment LEV | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 12 m - <= 15 m | 0.00 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment LEV | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 15 m - <= 18 m | 0.00 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment LEV | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 18 m - <= 21 m | 0.00 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment LEV | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 21 m - <= 24 m | 0.00 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment LEV | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 24 m - <= 27 m | 0.00 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment LEV | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 27 m - <= 30 m | 0.00 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment LEV | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 30 m - <= 33 m | 0.00 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment LEV | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 33 m - <= 36 m | 0.00 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment LEV | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 36 m - <= 39 m | 0.00 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment LEV | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 39 m - <= 42 m | 0.00 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment LEV | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 42 m - <= 45 m | 0.00 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment LEV | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 45 m - <= 48 m | 0.00 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment LEV | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 48 m - <= 51 m | 0.00 Number of Seizures (Type IC) per week |
| N165 Randomized Treatment LEV | Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | > 51 m - <= 54 m | 0.00 Number of Seizures (Type IC) per week |
Primary
Partial (Type I) Seizure Frequency Per Week by Analysis Visit
Number of Partial (Type I) seizures over the treatment period standardized to 1 week period.
Time frame: From Baseline up to 54 months
Population: Full Analysis set included 151 subjects. 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) |
|---|---|---|---|
| N165 Randomized Treatment PBO | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 15 m - <= 18 m | 1.36 Number of Seizures (Type I) per week |
| N165 Randomized Treatment PBO | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 30 m - <= 33 m | 1.21 Number of Seizures (Type I) per week |
| N165 Randomized Treatment PBO | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 9 m - <= 12 m | 1.41 Number of Seizures (Type I) per week |
| N165 Randomized Treatment PBO | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 33 m - <= 36 m | 1.14 Number of Seizures (Type I) per week |
| N165 Randomized Treatment PBO | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 18 m - <= 21 m | 1.35 Number of Seizures (Type I) per week |
| N165 Randomized Treatment PBO | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 36 m - <= 39 m | 1.20 Number of Seizures (Type I) per week |
| N165 Randomized Treatment PBO | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 6 m - <= 9 m | 1.58 Number of Seizures (Type I) per week |
| N165 Randomized Treatment PBO | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 39 m - <= 42 m | 1.25 Number of Seizures (Type I) per week |
| N165 Randomized Treatment PBO | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 21 m - <= 24 m | 1.30 Number of Seizures (Type I) per week |
| N165 Randomized Treatment PBO | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 42 m - <= 45 m | 1.17 Number of Seizures (Type I) per week |
| N165 Randomized Treatment PBO | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 12 m - <= 15 m | 1.58 Number of Seizures (Type I) per week |
| N165 Randomized Treatment PBO | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 45 m - <= 48 m | 0.95 Number of Seizures (Type I) per week |
| N165 Randomized Treatment PBO | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 24 m - <= 27 m | 1.25 Number of Seizures (Type I) per week |
| N165 Randomized Treatment PBO | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 48 m - <= 51 m | 0.90 Number of Seizures (Type I) per week |
| N165 Randomized Treatment PBO | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 3 m - <= 6 m | 1.69 Number of Seizures (Type I) per week |
| N165 Randomized Treatment PBO | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 51 m - <= 54 m | 1.06 Number of Seizures (Type I) per week |
| N165 Randomized Treatment PBO | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 27 m - <= 30 m | 1.30 Number of Seizures (Type I) per week |
| N165 Randomized Treatment PBO | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 54 m | 1.16 Number of Seizures (Type I) per week |
| N165 Randomized Treatment PBO | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | >= 1 day(d) - <= 3 months(m) | 1.68 Number of Seizures (Type I) per week |
| N165 Randomized Treatment LEV | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 54 m | 0.09 Number of Seizures (Type I) per week |
| N165 Randomized Treatment LEV | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | >= 1 day(d) - <= 3 months(m) | 2.19 Number of Seizures (Type I) per week |
| N165 Randomized Treatment LEV | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 3 m - <= 6 m | 2.00 Number of Seizures (Type I) per week |
| N165 Randomized Treatment LEV | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 6 m - <= 9 m | 1.78 Number of Seizures (Type I) per week |
| N165 Randomized Treatment LEV | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 9 m - <= 12 m | 1.60 Number of Seizures (Type I) per week |
| N165 Randomized Treatment LEV | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 12 m - <= 15 m | 1.55 Number of Seizures (Type I) per week |
| N165 Randomized Treatment LEV | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 15 m - <= 18 m | 1.69 Number of Seizures (Type I) per week |
| N165 Randomized Treatment LEV | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 18 m - <= 21 m | 1.51 Number of Seizures (Type I) per week |
| N165 Randomized Treatment LEV | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 21 m - <= 24 m | 1.36 Number of Seizures (Type I) per week |
| N165 Randomized Treatment LEV | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 24 m - <= 27 m | 1.33 Number of Seizures (Type I) per week |
| N165 Randomized Treatment LEV | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 27 m - <= 30 m | 1.28 Number of Seizures (Type I) per week |
| N165 Randomized Treatment LEV | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 30 m - <= 33 m | 1.33 Number of Seizures (Type I) per week |
| N165 Randomized Treatment LEV | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 33 m - <= 36 m | 1.30 Number of Seizures (Type I) per week |
| N165 Randomized Treatment LEV | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 36 m - <= 39 m | 1.28 Number of Seizures (Type I) per week |
| N165 Randomized Treatment LEV | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 39 m - <= 42 m | 1.32 Number of Seizures (Type I) per week |
| N165 Randomized Treatment LEV | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 42 m - <= 45 m | 1.28 Number of Seizures (Type I) per week |
| N165 Randomized Treatment LEV | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 45 m - <= 48 m | 1.09 Number of Seizures (Type I) per week |
| N165 Randomized Treatment LEV | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 48 m - <= 51 m | 0.70 Number of Seizures (Type I) per week |
| N165 Randomized Treatment LEV | Partial (Type I) Seizure Frequency Per Week by Analysis Visit | > 51 m - <= 54 m | 0.78 Number of Seizures (Type I) per week |
Secondary
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit
Percentage change from baseline of of Partial (Type IA) seizure frequency over the treatment period standardized to 1 week period. Negative values indicate improvement from Baseline.
Time frame: From Baseline up to 54 months
Population: Subjects with Type IA seizure count equal to zero during baseline and evaluation periods are excluded. Only subjects with valid data for partial (Type IA) 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) |
|---|---|---|---|
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 15 m - <= 18 m | -79.55 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 30 m - <= 33 m | -80.89 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 9 m - <= 12 m | -66.05 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 33 m - <= 36 m | -84.13 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 18 m - <= 21 m | -83.68 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 36 m - <= 39 m | -90.62 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 6 m - <= 9 m | -71.71 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 39 m - <= 42 m | -92.50 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 21 m - <= 24 m | -82.30 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 42 m - <= 45 m | -77.00 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 12 m - <= 15 m | -37.32 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 45 m - <= 48 m | -71.43 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 24 m - <= 27 m | -72.52 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 48 m - <= 51 m | -54.01 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 3 m - <= 6 m | -77.15 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 51 m - <= 54 m | -64.18 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 27 m - <= 30 m | -74.89 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 54 m | -59.19 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | >= 1 d - <= 3 m | -79.58 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 54 m | -97.55 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | >= 1 d - <= 3 m | -45.93 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 3 m - <= 6 m | -58.81 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 6 m - <= 9 m | -61.62 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 9 m - <= 12 m | -69.01 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 12 m - <= 15 m | -78.44 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 15 m - <= 18 m | -71.42 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 18 m - <= 21 m | -66.07 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 21 m - <= 24 m | -73.18 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 24 m - <= 27 m | -74.85 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 27 m - <= 30 m | -76.45 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 30 m - <= 33 m | -78.24 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 33 m - <= 36 m | -80.40 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 36 m - <= 39 m | -76.79 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 39 m - <= 42 m | -75.66 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 42 m - <= 45 m | -74.09 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 45 m - <= 48 m | -79.25 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 48 m - <= 51 m | -91.41 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | > 51 m - <= 54 m | -83.37 Percent change |
Secondary
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit
Percentage change from baseline of of Partial (Type IB) seizure frequency over the treatment period standardized to 1 week period. Negative values indicate improvement from Baseline.
Time frame: From Baseline up to 54 months
Population: Subjects with Type IB seizure count equal to zero during baseline and evaluation periods are excluded. Only subjects with valid data for partial (Type IB) 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) |
|---|---|---|---|
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 15 m - <= 18 m | -33.18 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 30 m - <= 33 m | -15.85 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 9 m - <= 12 m | -34.97 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 33 m - <= 36 m | -11.73 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 18 m - <= 21 m | -32.78 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 36 m - <= 39 m | -15.06 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 6 m - <= 9 m | -28.30 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 39 m - <= 42 m | -20.13 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 21 m - <= 24 m | -20.12 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 42 m - <= 45 m | -23.76 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 12 m - <= 15 m | -21.12 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 45 m - <= 48 m | -37.52 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 24 m - <= 27 m | -28.75 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 48 m - <= 51 m | -42.17 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | >= 1 d - <= 3 m | -21.41 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 51 m - <= 54 m | 5.38 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 27 m - <= 30 m | -8.84 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 54 m | 3.55 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 3 m - <= 6 m | -21.95 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 54 m | -86.61 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | >= 1 d - <= 3 m | -26.77 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 3 m - <= 6 m | -31.35 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 6 m - <= 9 m | -47.61 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 9 m - <= 12 m | -43.56 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 12 m - <= 15 m | -51.20 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 15 m - <= 18 m | -45.80 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 18 m - <= 21 m | -52.04 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 21 m - <= 24 m | -52.96 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 24 m - <= 27 m | -49.71 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 27 m - <= 30 m | -48.18 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 30 m - <= 33 m | -46.86 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 33 m - <= 36 m | -42.03 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 36 m - <= 39 m | -46.25 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 39 m - <= 42 m | -49.85 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 42 m - <= 45 m | -46.51 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 45 m - <= 48 m | -54.05 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 48 m - <= 51 m | -77.08 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | > 51 m - <= 54 m | -74.58 Percent change |
Secondary
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit
Percentage change from baseline of of Partial (Type IC) seizure frequency over the treatment period standardized to 1 week period. Negative values indicate improvement from Baseline.
Time frame: From Baseline up to 54 months
Population: Subjects with Type IC seizure count equal to zero during baseline and evaluation periods are excluded. Only subjects with valid data for partial (Type IC) 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) |
|---|---|---|---|
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 15 m - <= 18 m | -100.00 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 30 m - <= 33 m | -77.02 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 9 m - <= 12 m | -100.00 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 33 m - <= 36 m | -74.30 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 18 m - <= 21 m | -90.42 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 36 m - <= 39 m | -85.67 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 6 m - <= 9 m | -88.73 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 39 m - <= 42 m | -83.23 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 21 m - <= 24 m | -80.56 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 42 m - <= 45 m | -79.75 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 12 m - <= 15 m | -88.33 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 45 m - <= 48 m | -95.81 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 24 m - <= 27 m | -91.92 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 48 m - <= 51 m | -95.98 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 3 m - <= 6 m | -93.96 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 51 m - <= 54 m | -100.00 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 27 m - <= 30 m | -92.11 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 54 m | -100.00 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | >= 1 d - <= 3 m | -100.00 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 54 m | -100.00 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | >= 1 d - <= 3 m | -100.00 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 3 m - <= 6 m | -100.00 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 6 m - <= 9 m | -100.00 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 9 m - <= 12 m | -100.00 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 12 m - <= 15 m | -100.00 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 15 m - <= 18 m | -100.00 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 18 m - <= 21 m | -100.00 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 21 m - <= 24 m | -100.00 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 24 m - <= 27 m | -100.00 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 27 m - <= 30 m | -100.00 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 30 m - <= 33 m | -100.00 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 33 m - <= 36 m | -100.00 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 36 m - <= 39 m | -100.00 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 39 m - <= 42 m | -100.00 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 42 m - <= 45 m | -100.00 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 45 m - <= 48 m | -100.00 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 48 m - <= 51 m | -100.00 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | > 51 m - <= 54 m | -100.00 Percent change |
Secondary
Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit
Percentage change from baseline of of Partial (Type I) seizure frequency over the treatment period standardized to 1 week period. Negative values indicate improvement from Baseline.
Time frame: From Baseline up to 54 months
Population: Full Analysis set included 151 subjects. 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) |
|---|---|---|---|
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 15 m - <= 18 m | -44.44 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 30 m - <= 33 m | -29.96 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 9 m - <= 12 m | -41.44 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 33 m - <= 36 m | -40.03 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 18 m - <= 21 m | -37.58 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 36 m - <= 39 m | -43.67 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 6 m - <= 9 m | -38.42 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 39 m - <= 42 m | -42.88 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 21 m - <= 24 m | -45.75 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 42 m - <= 45 m | -45.06 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 12 m - <= 15 m | -29.58 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 45 m - <= 48 m | -42.41 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 24 m - <= 27 m | -50.89 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 48 m - <= 51 m | -49.11 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 3 m - <= 6 m | -35.15 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 51 m - <= 54 m | -43.74 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 27 m - <= 30 m | -40.54 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 54 m | -40.72 Percent change |
| N165 Randomized Treatment PBO | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | >= 1 d - <= 3 m | -27.39 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 54 m | -90.00 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | >= 1 d - <= 3 m | -31.24 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 3 m - <= 6 m | -34.74 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 6 m - <= 9 m | -43.03 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 9 m - <= 12 m | -43.11 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 12 m - <= 15 m | -46.38 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 15 m - <= 18 m | -43.17 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 18 m - <= 21 m | -49.61 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 21 m - <= 24 m | -52.96 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 24 m - <= 27 m | -53.78 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 27 m - <= 30 m | -47.71 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 30 m - <= 33 m | -43.09 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 33 m - <= 36 m | -39.01 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 36 m - <= 39 m | -44.42 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 39 m - <= 42 m | -47.69 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 42 m - <= 45 m | -71.96 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 45 m - <= 48 m | -80.02 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 48 m - <= 51 m | -78.28 Percent change |
| N165 Randomized Treatment LEV | Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | > 51 m - <= 54 m | -81.81 Percent change |