Lennox-Gastaut Syndrome
Conditions
Keywords
Central Nervous System
Brief summary
This study was designed to evaluate the cognitive effect, safety, and pharmacokinetics (PK) of rufinamide on Lennox-Gastaut Syndrome (LGS) inadequately controlled in pediatric participants already taking other anti-epileptic drugs.
Interventions
DRUGRufinamide
Rufinamide up to 45 mg/kg/day, in 2 divided doses, administered as oral suspension (40 mg/mL) as an add-on to the subject's existing regimen of 1-3 antiepileptic drugs (AEDs)
DRUGAny other approved Antiepileptic Drug
Any other approved AED: any other approved AED of the investigator's choice as an add-on to the subject's existing regimen of 1-3 anti-epileptic drugs (AEDs)
Sponsors
Eisai Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 3 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion: 1. Clinical diagnosis of LGS, which might include the presence of a slow background electroencephalogram (EEG) rhythm, slow spikes-waves pattern (less than 3 Hz), the presence of polyspikes; care should be taken not to include benign myoclonic epilepsy of infancy, atypical benign partial epilepsy (pseudo-Lennox syndrome), or continuous spike-waves of slow sleep (CSWS). 2. On a fixed and documented dose of one to three concomitant regionally approved antiepileptic drugs (AEDs) for a minimum of 4 weeks prior to randomization with an inadequate response to treatment. 3. Consistent seizure documentation (i.e., no uncertainty of the presence of seizures) during the pre-randomization phase. Key Exclusion: 1. Familial short QT syndrome 2. Prior treatment with rufinamide within 30 days of baseline visit or discontinuation of rufinamide treatment due to safety issues related to rufinamide
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child Behavior Checklist (CBCL) Total Problem T-scores at the End of 2-year Treatment Period | End of Treatment Period (up to approximately Week 106) | CBCL: 99-item questionnaire measures specific behavioral problems or developmental delays, answered by a parent/legal guardian or suitable caregiver. Each item were rated using 3-point scale (0=Not True, 1=Somewhat/Sometimes True, 2=Very True/ Often True) to indicate how often or typical the behavior was. The 99 items were combined to yield scores for 8 problem area scales (emotionally reactive, anxious/depressed, somatic complaints, withdrawn, sleep problems, attention problems, aggressive behavior, and other problems) and 3 summary scores (internalizing, externalizing, and total problems). Total Problem score was sum of all the problem areas plus 1 additional item, ranging from 0 to 198. Total raw scores are converted to t-scores with mean of 50 and standard deviation (SD) of 10. T-scores were standardized test scores that indicate same degree of elevation in problems relative to the normative sample of peers. Higher scores were indicative of more problems. |
| Change From Baseline in CBCL Total Problem T-Scores at End of 2-year Treatment Period | Baseline and End of Treatment Period (up to approximately Week 106) | CBCL: 99-item questionnaire measures specific behavioral problems or developmental delays, answered by a parent/legal guardian or suitable caregiver. Each item were rated using 3-point scale (0=Not True, 1=Somewhat/Sometimes True, 2=Very True/ Often True) to indicate how often or typical the behavior was. The 99 items were combined to yield scores for 8 problem area scales (emotionally reactive, anxious/depressed, somatic complaints, withdrawn, sleep problems, attention problems, aggressive behavior, and other problems) and 3 summary scores (internalizing, externalizing, and total problems). Total Problem score was sum of all the problem areas plus 1 additional item, ranging from 0 to 198. Total raw scores are converted to t-scores with mean of 50 and standard deviation (SD) of 10. T-scores were standardized test scores that indicate same degree of elevation in problems relative to the normative sample of peers. Higher scores were indicative of more problems. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to Withdrawal From Treatment Due to an Adverse Event or Lack of Efficacy | Baseline up to the End of the Treatment Period (up to approximately Week 106) | Withdrawal from either rufinamide or other AED was due to the occurrence of an adverse event or for lack of efficacy. Data was obtained till Week 106 and was extrapolated using Kaplan-Meier method to determine the overall survival time (in weeks) to withdrawal from treatment (excluding taper) due to an adverse event or lack efficacy. |
| Percent Change in Total Seizure Frequency Per 28 Days | Baseline up to End of the Treatment Period (up to approximately Week 106) | The frequency per 28 days was defined as (S/D)\*28 where, S was equal to the sum of the seizures reported in the participant seizure diary during the specified time interval and D was equal to the number of days with non-missing data in the participant seizure diary for the specified study phase. The number of seizures was assessed and recorded by the participant's parent(s)/caregiver(s) in the participant seizure diary. |
| Percent Change in Seizure Frequency by Individual Seizure Type Per 28 Days | Baseline up to End of Treatment Period (up to approximately Week 106) | The frequency per 28 days was defined as (S/D)\*28 where, S was equal to the sum of the seizures reported in the participant seizure diary during the specified time interval and D was equal to the number of days with non-missing data in the participant seizure diary for the specified study phase. The number of seizures was assessed and recorded by the participant's parent(s)/caregiver(s) in the participant seizure diary. |
| Incidence of Worsening of Seizures | Baseline up to End of Treatment Period (up to approximately Week 106) | Worsening of seizures was summarized by the incidence of participants with doubling in total seizure frequency, doubling in frequency of major seizures (generalized tonic-clonic, drop attacks), or occurrence of new seizure type during each successive 3 to 4 month visit interval of the Maintenance Period relative to baseline. |
| Change From Baseline in CBCL Sub Scores at Week 106 | Baseline and Week 106 | CBCL: 99-item questionnaire, measures behavioral problems/developmental delays, answered by parent/guardian/caregiver. Each item rated on 3-point scale (0=Not True,1=Somewhat/Sometimes True, 2=Very/Often True). 99 items were combined to give scores for 8 problem area scales, where 1 for each 8 syndrome (emotionally reactive, anxious/depressed, somatic, withdrawn, sleep, attention, aggressive behavior, and other problems) were calculated, range: 0 (normal) to 16 (clinical behavior) and 3 summary scores (internalizing, externalizing, and total problems). All 3 summary scores reported scaled to T-scores. Total Problem score was sum of all the problem areas plus 1 additional item, ranging from 0 to 198. Total raw score were converted to t-scores with mean of 50 and SD of 10. T-scores were standardized test scores that indicate same degree of elevation in problems relative to normative sample of peers. Higher scores were indicative of more problems. |
| Change From Baseline in Sub-scores in QoLCE | Baseline and Week 106 | The QoLCE was a 76-item questionnaire designed specifically to measure quality of life in children with epilepsy. QOLCE consists of 16 quality of life subscales (14 multi-item and 2 single item). Each subscales had number of items or questions with responses as excellent, very good, good, fair, and poor. They were changed to 1, 2, 3, 4, and 5 as per instructions. Then changed on a scale of 100, where 1=0, 2=25, 3=50, 4=75, and 5=100. Items corresponding to each subscale were marked and there mean score was score of that subscale. The form was completed by a parent or caregiver who interacted with the child on a consistent, daily basis and took about 20 to 30 minutes to complete. The higher the score, the better the child's quality of life. |
| Change From Baseline in Language Development Survey (LDS) Scores During Maintenance Period | Baseline, Weeks 24, 56, 88, and 106 | LDS, a caregiver-administered survey consisted of 8-item questionnaire and vocabulary list of 310 words organized within 14 semantic categories. List contained high frequency words (e.g. more), less common words (e.g. hamburger), and lexical chunks (e.g. Sesame Street). Average LDS score, calculated by dividing total number of words across all valid phrases by number of phrases with greater than (\>) 0words; for participants with no words, average was 0. This value was compared to standardized chart to obtain percentile rating. LDS provided 2 scores: average phrase length (number of words/phrase) and number of endorsed vocabulary words. LDS phrase length was categorized into delay (less than or equal to \[\<=\] 20th percentile) and no delay (\>20th percentile). LDS vocabulary was categorized into delay(\<=15th percentile)and no delay(\>15th percentile). Both raw scores were used to provide 2 normative scores based on child's age in months. Higher scores indicated better language development. |
| Change From Baseline in Total Score of Quality of Life in Childhood Epilepsy (QoLCE) Scale | Baseline and Week 106 | The QoLCE was a 76-item questionnaire designed specifically to measure quality of life in children with epilepsy. QOLCE consists of 16 quality of life subscales (14 multi-item and 2 single item). Each subscales had number of items or questions with responses as excellent, very good, good, fair, and poor. They were changed to 1, 2, 3, 4, and 5 as per instructions. Then changed on a scale of 100, where 1 is equal to (=) 0, 2=25, 3=50, 4=75, and 5=100. Items corresponding to each subscale were marked and there mean score was score of that subscale. The form was completed by a parent or caregiver who interacted with the child on a consistent, daily basis and took about 20 to 30 minutes to complete. The higher the score, the better the child's quality of life. |
Countries
Canada, France, Greece, Italy, Poland, South Africa, United States
Participant flow
Recruitment details
Participants took part in the study at 19 investigative sites in the United States, Canada, France, Greece, Italy, and Poland from 16 June 2011 to 02 November 2015.
Pre-assignment details
A total of 43 participants were screened, out of which 37 participants were randomized and treated in the study.
Participants by arm
| Arm | Count |
|---|---|
| Rufinamide Participants received rufinamide oral suspension as an add-on therapy to the participant's existing regimen of 1 to 3 AEDs. Participants underwent a 2 week Titration Period during which rufinamide dose was increased from 10 mg/kg/day in increments of 10 mg/kg/day every 3 days to 40 mg/kg/day and thereafter in increments of 5 mg/kg/day to the target maintenance dose of 45 mg/kg/day (all daily treatments were to be administered in 2 equally divided doses). Rufinamide dose reached at the end of the Titration period were to be maintained the same throughout the 104-week Maintenance Period. At the end of Maintenance Period, rufinamide dose should be tapered (as needed) over a period of 2 weeks. | 25 |
| Any Other Approved Antiepileptic Drug Participants received any other approved AEDs of the investigator's choice, dosed according to the investigator's usual practice, added to the participant's existing regimen of 1 to 3 AEDs. At the end of Maintenance Period, the AED comparator would be discontinued according to the investigator's usual practice. | 12 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 |
| Overall Study | Inadequate therapeutic effect | 2 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Other | 0 | 1 |
| Overall Study | Participant choice | 2 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 4 |
Baseline characteristics
| Characteristic | Rufinamide | Any Other Approved Antiepileptic Drug | Total |
|---|---|---|---|
| Age, Continuous | 28.3 months STANDARD_DEVIATION 9.99 | 29.8 months STANDARD_DEVIATION 9.85 | 28.8 months STANDARD_DEVIATION 9.83 |
| Sex: Female, Male Female | 11 Participants | 2 Participants | 13 Participants |
| Sex: Female, Male Male | 14 Participants | 10 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 25 | 0 / 12 |
| other Total, other adverse events | 21 / 25 | 10 / 12 |
| serious Total, serious adverse events | 10 / 25 | 5 / 12 |
Outcome results
Primary
Change From Baseline in CBCL Total Problem T-Scores at End of 2-year Treatment Period
CBCL: 99-item questionnaire measures specific behavioral problems or developmental delays, answered by a parent/legal guardian or suitable caregiver. Each item were rated using 3-point scale (0=Not True, 1=Somewhat/Sometimes True, 2=Very True/ Often True) to indicate how often or typical the behavior was. The 99 items were combined to yield scores for 8 problem area scales (emotionally reactive, anxious/depressed, somatic complaints, withdrawn, sleep problems, attention problems, aggressive behavior, and other problems) and 3 summary scores (internalizing, externalizing, and total problems). Total Problem score was sum of all the problem areas plus 1 additional item, ranging from 0 to 198. Total raw scores are converted to t-scores with mean of 50 and standard deviation (SD) of 10. T-scores were standardized test scores that indicate same degree of elevation in problems relative to the normative sample of peers. Higher scores were indicative of more problems.
Time frame: Baseline and End of Treatment Period (up to approximately Week 106)
Population: The full analysis set for primary efficacy variable included randomized participants who received rufinamide or any other approved add-on AED of the investigator's choice and had baseline and at least 1 postdose cognition measurement. Participants who were evaluable for this outcome measure at given time period were included for assessment.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Rufinamide | Change From Baseline in CBCL Total Problem T-Scores at End of 2-year Treatment Period | Baseline | 56.6 score on a scale | Standard Deviation 11.27 |
| Rufinamide | Change From Baseline in CBCL Total Problem T-Scores at End of 2-year Treatment Period | Change at Week 106 | -0.3 score on a scale | Standard Deviation 15.72 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in CBCL Total Problem T-Scores at End of 2-year Treatment Period | Baseline | 62.8 score on a scale | Standard Deviation 13.07 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in CBCL Total Problem T-Scores at End of 2-year Treatment Period | Change at Week 106 | -6.7 score on a scale | Standard Deviation 0.58 |
Primary
Child Behavior Checklist (CBCL) Total Problem T-scores at the End of 2-year Treatment Period
CBCL: 99-item questionnaire measures specific behavioral problems or developmental delays, answered by a parent/legal guardian or suitable caregiver. Each item were rated using 3-point scale (0=Not True, 1=Somewhat/Sometimes True, 2=Very True/ Often True) to indicate how often or typical the behavior was. The 99 items were combined to yield scores for 8 problem area scales (emotionally reactive, anxious/depressed, somatic complaints, withdrawn, sleep problems, attention problems, aggressive behavior, and other problems) and 3 summary scores (internalizing, externalizing, and total problems). Total Problem score was sum of all the problem areas plus 1 additional item, ranging from 0 to 198. Total raw scores are converted to t-scores with mean of 50 and standard deviation (SD) of 10. T-scores were standardized test scores that indicate same degree of elevation in problems relative to the normative sample of peers. Higher scores were indicative of more problems.
Time frame: End of Treatment Period (up to approximately Week 106)
Population: The full analysis set for primary efficacy variable included randomized participants who received rufinamide or any other approved add-on AED of the investigator's choice and had baseline and at least 1 postdose cognition measurement. Participants who were evaluable for this outcome measure at given time period were included for assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rufinamide | Child Behavior Checklist (CBCL) Total Problem T-scores at the End of 2-year Treatment Period | 55.7 score on a scale | Standard Deviation 15.81 |
| Any Other Approved Antiepileptic Drug | Child Behavior Checklist (CBCL) Total Problem T-scores at the End of 2-year Treatment Period | 54.8 score on a scale | Standard Deviation 4.5 |
Comparison: The primary statistical model for comparing the 2 treatment groups was an analysis of covariance (ANCOVA) mixed model for repeated measures with baseline score, age, and sex as covariates, and treatment, week, and treatment by week interaction as factors.p-value: 0.692895% CI: [-10.5, 15.7]ANCOVA
Other Pre-specified
Change From Baseline in CBCL Sub Scores at Week 106
CBCL: 99-item questionnaire, measures behavioral problems/developmental delays, answered by parent/guardian/caregiver. Each item rated on 3-point scale (0=Not True,1=Somewhat/Sometimes True, 2=Very/Often True). 99 items were combined to give scores for 8 problem area scales, where 1 for each 8 syndrome (emotionally reactive, anxious/depressed, somatic, withdrawn, sleep, attention, aggressive behavior, and other problems) were calculated, range: 0 (normal) to 16 (clinical behavior) and 3 summary scores (internalizing, externalizing, and total problems). All 3 summary scores reported scaled to T-scores. Total Problem score was sum of all the problem areas plus 1 additional item, ranging from 0 to 198. Total raw score were converted to t-scores with mean of 50 and SD of 10. T-scores were standardized test scores that indicate same degree of elevation in problems relative to normative sample of peers. Higher scores were indicative of more problems.
Time frame: Baseline and Week 106
Population: The full analysis set for other efficacy variable included randomized participants who received rufinamide or any other approved add-on AED of the investigator's choice and had a baseline efficacy and at least 1 postbaseline efficacy assessment. Participants evaluable for this outcome measure at given time period were included for assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rufinamide | Change From Baseline in CBCL Sub Scores at Week 106 | Baseline: Total emotional reactive scores | 59.0 score on a scale | Standard Deviation 8.13 |
| Rufinamide | Change From Baseline in CBCL Sub Scores at Week 106 | Change at Week 106:Total emotional reactive scores | -1.1 score on a scale | Standard Deviation 9.3 |
| Rufinamide | Change From Baseline in CBCL Sub Scores at Week 106 | Baseline: Total anxious/depression scores | 56.4 score on a scale | Standard Deviation 7.48 |
| Rufinamide | Change From Baseline in CBCL Sub Scores at Week 106 | Change at Week 106:Total anxious/depression scores | 0.5 score on a scale | Standard Deviation 8.87 |
| Rufinamide | Change From Baseline in CBCL Sub Scores at Week 106 | Baseline: Total Somatic Complaints Scores | 59.4 score on a scale | Standard Deviation 8.13 |
| Rufinamide | Change From Baseline in CBCL Sub Scores at Week 106 | Change at Week 106:Total Somatic Complaints Scores | 0.1 score on a scale | Standard Deviation 11.24 |
| Rufinamide | Change From Baseline in CBCL Sub Scores at Week 106 | Baseline: Total withdrawn scores | 71.5 score on a scale | Standard Deviation 11.72 |
| Rufinamide | Change From Baseline in CBCL Sub Scores at Week 106 | Change at Week 106:Total withdrawn scores | -2.2 score on a scale | Standard Deviation 13.22 |
| Rufinamide | Change From Baseline in CBCL Sub Scores at Week 106 | Baseline: Total Sleep Problems Scores | 57.8 score on a scale | Standard Deviation 10.72 |
| Rufinamide | Change From Baseline in CBCL Sub Scores at Week 106 | Change at Week 106:Total sleep problem scores | -1.9 score on a scale | Standard Deviation 12.3 |
| Rufinamide | Change From Baseline in CBCL Sub Scores at Week 106 | Baseline: Total attention problems scores | 59.3 score on a scale | Standard Deviation 9.17 |
| Rufinamide | Change From Baseline in CBCL Sub Scores at Week 106 | Change at Week 106:Total attention problems scores | -1.1 score on a scale | Standard Deviation 4.65 |
| Rufinamide | Change From Baseline in CBCL Sub Scores at Week 106 | Baseline: Total Aggressive Behavior Scores | 52.5 score on a scale | Standard Deviation 5.01 |
| Rufinamide | Change From Baseline in CBCL Sub Scores at Week 106 | Change at Week106:Total aggressive behavior scores | 3.2 score on a scale | Standard Deviation 6.26 |
| Rufinamide | Change From Baseline in CBCL Sub Scores at Week 106 | Baseline: Total internalizing scores | 61.6 score on a scale | Standard Deviation 10.78 |
| Rufinamide | Change From Baseline in CBCL Sub Scores at Week 106 | Change at Week 106:Total internalizing scores | -1.5 score on a scale | Standard Deviation 13.73 |
| Rufinamide | Change From Baseline in CBCL Sub Scores at Week 106 | Baseline: Total externalizing scores | 47.5 score on a scale | Standard Deviation 11.22 |
| Rufinamide | Change From Baseline in CBCL Sub Scores at Week 106 | Change at Week 106:Total externalizing scores | 4.7 score on a scale | Standard Deviation 10.07 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in CBCL Sub Scores at Week 106 | Change at Week106:Total aggressive behavior scores | -0.3 score on a scale | Standard Deviation 2.89 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in CBCL Sub Scores at Week 106 | Baseline: Total emotional reactive scores | 60.9 score on a scale | Standard Deviation 8.64 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in CBCL Sub Scores at Week 106 | Change at Week 106:Total sleep problem scores | -5.7 score on a scale | Standard Deviation 7.57 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in CBCL Sub Scores at Week 106 | Change at Week 106:Total emotional reactive scores | -1.3 score on a scale | Standard Deviation 6.11 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in CBCL Sub Scores at Week 106 | Change at Week 106:Total externalizing scores | -3.7 score on a scale | Standard Deviation 3.51 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in CBCL Sub Scores at Week 106 | Baseline: Total anxious/depression scores | 54.6 score on a scale | Standard Deviation 6.67 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in CBCL Sub Scores at Week 106 | Baseline: Total attention problems scores | 65.9 score on a scale | Standard Deviation 10.72 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in CBCL Sub Scores at Week 106 | Change at Week 106:Total anxious/depression scores | 0.7 score on a scale | Standard Deviation 1.15 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in CBCL Sub Scores at Week 106 | Baseline: Total internalizing scores | 60.6 score on a scale | Standard Deviation 9.71 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in CBCL Sub Scores at Week 106 | Baseline: Total Somatic Complaints Scores | 54.9 score on a scale | Standard Deviation 4.7 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in CBCL Sub Scores at Week 106 | Change at Week 106:Total attention problems scores | -7.7 score on a scale | Standard Deviation 2.52 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in CBCL Sub Scores at Week 106 | Change at Week 106:Total Somatic Complaints Scores | -1.7 score on a scale | Standard Deviation 2.89 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in CBCL Sub Scores at Week 106 | Baseline: Total externalizing scores | 58.1 score on a scale | Standard Deviation 15.92 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in CBCL Sub Scores at Week 106 | Baseline: Total withdrawn scores | 72.1 score on a scale | Standard Deviation 11.03 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in CBCL Sub Scores at Week 106 | Baseline: Total Aggressive Behavior Scores | 58.6 score on a scale | Standard Deviation 12.07 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in CBCL Sub Scores at Week 106 | Change at Week 106:Total withdrawn scores | -7.0 score on a scale | Standard Deviation 9.54 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in CBCL Sub Scores at Week 106 | Change at Week 106:Total internalizing scores | -2.7 score on a scale | Standard Deviation 1.53 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in CBCL Sub Scores at Week 106 | Baseline: Total Sleep Problems Scores | 62.4 score on a scale | Standard Deviation 8.57 |
Other Pre-specified
Change From Baseline in Language Development Survey (LDS) Scores During Maintenance Period
LDS, a caregiver-administered survey consisted of 8-item questionnaire and vocabulary list of 310 words organized within 14 semantic categories. List contained high frequency words (e.g. more), less common words (e.g. hamburger), and lexical chunks (e.g. Sesame Street). Average LDS score, calculated by dividing total number of words across all valid phrases by number of phrases with greater than (\>) 0words; for participants with no words, average was 0. This value was compared to standardized chart to obtain percentile rating. LDS provided 2 scores: average phrase length (number of words/phrase) and number of endorsed vocabulary words. LDS phrase length was categorized into delay (less than or equal to \[\<=\] 20th percentile) and no delay (\>20th percentile). LDS vocabulary was categorized into delay(\<=15th percentile)and no delay(\>15th percentile). Both raw scores were used to provide 2 normative scores based on child's age in months. Higher scores indicated better language development.
Time frame: Baseline, Weeks 24, 56, 88, and 106
Population: The full analysis set for other efficacy variable included randomized participants who received rufinamide or any other approved add-on AED of the investigator's choice and had a baseline efficacy and at least 1 postbaseline efficacy assessment. Participants evaluable for this outcome measure at given time period were included for assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rufinamide | Change From Baseline in Language Development Survey (LDS) Scores During Maintenance Period | Baseline: LDS average phrase length | 0.3 words | Standard Deviation 0.87 |
| Rufinamide | Change From Baseline in Language Development Survey (LDS) Scores During Maintenance Period | Change at Week 24: LDS average phrase length | 0.2 words | Standard Deviation 1.11 |
| Rufinamide | Change From Baseline in Language Development Survey (LDS) Scores During Maintenance Period | Change at Week 56: LDS average phrase length | 0.1 words | Standard Deviation 1.02 |
| Rufinamide | Change From Baseline in Language Development Survey (LDS) Scores During Maintenance Period | Change at Week 88: LDS average phrase length | 0.1 words | Standard Deviation 1.03 |
| Rufinamide | Change From Baseline in Language Development Survey (LDS) Scores During Maintenance Period | Change at Week 106: LDS average phrase length | 0.4 words | Standard Deviation 1.12 |
| Rufinamide | Change From Baseline in Language Development Survey (LDS) Scores During Maintenance Period | Baseline:LDS Vocabulary Score | 10.4 words | Standard Deviation 37.72 |
| Rufinamide | Change From Baseline in Language Development Survey (LDS) Scores During Maintenance Period | Change at Week 24:LDS Vocabulary Score | 7.1 words | Standard Deviation 21.55 |
| Rufinamide | Change From Baseline in Language Development Survey (LDS) Scores During Maintenance Period | Change at Week 56:LDS Vocabulary Score | 17.9 words | Standard Deviation 39.24 |
| Rufinamide | Change From Baseline in Language Development Survey (LDS) Scores During Maintenance Period | Change at Week 88:LDS Vocabulary Score | 25.4 words | Standard Deviation 49.87 |
| Rufinamide | Change From Baseline in Language Development Survey (LDS) Scores During Maintenance Period | Change at Week 106:LDS Vocabulary Score | 39.6 words | Standard Deviation 75.62 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Language Development Survey (LDS) Scores During Maintenance Period | Change at Week 56:LDS Vocabulary Score | -0.40 words | Standard Deviation 2.15 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Language Development Survey (LDS) Scores During Maintenance Period | Baseline: LDS average phrase length | 0 words | Standard Deviation 0 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Language Development Survey (LDS) Scores During Maintenance Period | Baseline:LDS Vocabulary Score | 0.6 words | Standard Deviation 1.67 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Language Development Survey (LDS) Scores During Maintenance Period | Change at Week 24: LDS average phrase length | 0.7 words | Standard Deviation 1.28 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Language Development Survey (LDS) Scores During Maintenance Period | Change at Week 106:LDS Vocabulary Score | 1.0 words | Standard Deviation 2 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Language Development Survey (LDS) Scores During Maintenance Period | Change at Week 56: LDS average phrase length | 0.0 words | Standard Deviation 0 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Language Development Survey (LDS) Scores During Maintenance Period | Change at Week 24:LDS Vocabulary Score | 4.8 words | Standard Deviation 8.22 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Language Development Survey (LDS) Scores During Maintenance Period | Change at Week 88: LDS average phrase length | 0.0 words | Standard Deviation 0 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Language Development Survey (LDS) Scores During Maintenance Period | Change at Week 88:LDS Vocabulary Score | 0.0 words | Standard Deviation 0 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Language Development Survey (LDS) Scores During Maintenance Period | Change at Week 106: LDS average phrase length | 0.0 words | Standard Deviation 0 |
Other Pre-specified
Change From Baseline in Sub-scores in QoLCE
The QoLCE was a 76-item questionnaire designed specifically to measure quality of life in children with epilepsy. QOLCE consists of 16 quality of life subscales (14 multi-item and 2 single item). Each subscales had number of items or questions with responses as excellent, very good, good, fair, and poor. They were changed to 1, 2, 3, 4, and 5 as per instructions. Then changed on a scale of 100, where 1=0, 2=25, 3=50, 4=75, and 5=100. Items corresponding to each subscale were marked and there mean score was score of that subscale. The form was completed by a parent or caregiver who interacted with the child on a consistent, daily basis and took about 20 to 30 minutes to complete. The higher the score, the better the child's quality of life.
Time frame: Baseline and Week 106
Population: The full analysis set for other efficacy variable included randomized participants who received rufinamide or any other approved add-on AED of the investigator's choice and had a baseline efficacy and at least 1 postbaseline efficacy assessment. Participants evaluable for this outcome measure at given time period were included for assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Baseline: Language | 49.8 score on a scale | Standard Deviation 10.42 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: Physical restriction | -1.0 score on a scale | Standard Deviation 7.51 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Baseline: Energy/Fatigue | 51.6 score on a scale | Standard Deviation 10.48 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: Energy/Fatigue | -3.1 score on a scale | Standard Deviation 12.22 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Baseline: Attention/Concentration | 49.9 score on a scale | Standard Deviation 10.14 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Change at Week 106:Attention/Concentration | -2.1 score on a scale | Standard Deviation 7.31 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Baseline: Memory | 50.2 score on a scale | Standard Deviation 9.54 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: Memory | -0.5 score on a scale | Standard Deviation 12.18 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Baseline: Physical restriction | 50.1 score on a scale | Standard Deviation 10.33 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: Language | -0.5 score on a scale | Standard Deviation 9.63 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Baseline: Other cognitive | 48.6 score on a scale | Standard Deviation 10.32 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: Other cognitive | 0.3 score on a scale | Standard Deviation 6.19 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Baseline: Depression | 51.2 score on a scale | Standard Deviation 9.27 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: Depression | -2.6 score on a scale | Standard Deviation 11.64 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Baseline: Anxiety | 50.1 score on a scale | Standard Deviation 10.27 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: Anxiety | -0.1 score on a scale | Standard Deviation 12.12 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Baseline: Control/Helplessness | 50.7 score on a scale | Standard Deviation 9.31 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: Control/Helplessness | 0.2 score on a scale | Standard Deviation 10.9 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Baseline: Self-esteem | 50.1 score on a scale | Standard Deviation 10.18 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: Self-esteem | -1.3 score on a scale | Standard Deviation 9.48 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Baseline: Social interactions | 49.9 score on a scale | Standard Deviation 10.56 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: Social interactions | -1.5 score on a scale | Standard Deviation 11.64 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Baseline: Social activities | 50.5 score on a scale | Standard Deviation 10.5 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: Social activities | 0.9 score on a scale | Standard Deviation 11.3 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Baseline: Stigma | 48.9 score on a scale | Standard Deviation 11.06 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: Stigma | -0.1 score on a scale | Standard Deviation 12.67 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Baseline: Behavior | 51.4 score on a scale | Standard Deviation 10.39 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: Behavior | 0.2 score on a scale | Standard Deviation 5.92 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Baseline: General-health | 50.5 score on a scale | Standard Deviation 10.02 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: General health | -1.3 score on a scale | Standard Deviation 10.98 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Baseline: Quality-of-life | 49.5 score on a scale | Standard Deviation 9.71 |
| Rufinamide | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: Quality-of-life | 1.1 score on a scale | Standard Deviation 9.46 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: Quality-of-life | 3.3 score on a scale | Standard Deviation 12.28 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Baseline: Physical restriction | 49.9 score on a scale | Standard Deviation 8.23 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Baseline: Control/Helplessness | 47.8 score on a scale | Standard Deviation 12.27 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: Physical restriction | -6.8 score on a scale | Standard Deviation 7.32 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Baseline: Stigma | 50.7 score on a scale | Standard Deviation 8.07 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Baseline: Energy/Fatigue | 44.3 score on a scale | Standard Deviation 4.55 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: Control/Helplessness | 3.0 score on a scale | Standard Deviation 11.52 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: Energy/Fatigue | 2.8 score on a scale | Standard Deviation 4.11 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Baseline: General-health | 49.0 score on a scale | Standard Deviation 8.4 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Baseline: Attention/Concentration | 51.1 score on a scale | Standard Deviation 9.05 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Baseline: Self-esteem | 50.5 score on a scale | Standard Deviation 10.98 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Change at Week 106:Attention/Concentration | 2.5 score on a scale | Standard Deviation 6.24 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: Stigma | 4.5 score on a scale | Standard Deviation 10.25 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Baseline: Memory | 52.6 score on a scale | Standard Deviation 6.57 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: Self-esteem | -6.0 score on a scale | Standard Deviation 8.08 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: Memory | 0.5 score on a scale | Standard Deviation 1 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Baseline: Quality-of-life | 50.7 score on a scale | Standard Deviation 9.98 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Baseline: Language | 53.1 score on a scale | Standard Deviation 4.43 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Baseline: Social interactions | 50.5 score on a scale | Standard Deviation 8.48 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: Language | -0.5 score on a scale | Standard Deviation 11.56 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Baseline: Behavior | 45.8 score on a scale | Standard Deviation 9.33 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Baseline: Other cognitive | 53.1 score on a scale | Standard Deviation 7.54 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: Social interactions | 4.0 score on a scale | Standard Deviation 5.89 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: Other cognitive | -1.0 score on a scale | Standard Deviation 4 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: General health | -2.0 score on a scale | Standard Deviation 10.86 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Baseline: Depression | 45.3 score on a scale | Standard Deviation 10.59 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Baseline: Social activities | 46.6 score on a scale | Standard Deviation 3.96 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: Depression | 2.3 score on a scale | Standard Deviation 8.62 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: Behavior | 7.3 score on a scale | Standard Deviation 6.55 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Baseline: Anxiety | 48.5 score on a scale | Standard Deviation 12.29 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: Social activities | 3.5 score on a scale | Standard Deviation 3.7 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Sub-scores in QoLCE | Change at Week 106: Anxiety | 1.3 score on a scale | Standard Deviation 6.9 |
Other Pre-specified
Change From Baseline in Total Score of Quality of Life in Childhood Epilepsy (QoLCE) Scale
The QoLCE was a 76-item questionnaire designed specifically to measure quality of life in children with epilepsy. QOLCE consists of 16 quality of life subscales (14 multi-item and 2 single item). Each subscales had number of items or questions with responses as excellent, very good, good, fair, and poor. They were changed to 1, 2, 3, 4, and 5 as per instructions. Then changed on a scale of 100, where 1 is equal to (=) 0, 2=25, 3=50, 4=75, and 5=100. Items corresponding to each subscale were marked and there mean score was score of that subscale. The form was completed by a parent or caregiver who interacted with the child on a consistent, daily basis and took about 20 to 30 minutes to complete. The higher the score, the better the child's quality of life.
Time frame: Baseline and Week 106
Population: The full analysis set for other efficacy variable included randomized participants who received rufinamide or any other add-on AED of the investigator's choice and had a baseline efficacy assessment and at least 1 postbaseline efficacy assessment. Participants evaluable for this outcome measure at given time period were included for assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rufinamide | Change From Baseline in Total Score of Quality of Life in Childhood Epilepsy (QoLCE) Scale | Baseline | 50.4 score on a scale | Standard Deviation 10.05 |
| Rufinamide | Change From Baseline in Total Score of Quality of Life in Childhood Epilepsy (QoLCE) Scale | Week 106 | -1.3 score on a scale | Standard Deviation 8.49 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Total Score of Quality of Life in Childhood Epilepsy (QoLCE) Scale | Baseline | 49.6 score on a scale | Standard Deviation 7.88 |
| Any Other Approved Antiepileptic Drug | Change From Baseline in Total Score of Quality of Life in Childhood Epilepsy (QoLCE) Scale | Week 106 | 1.5 score on a scale | Standard Deviation 1 |
Other Pre-specified
Incidence of Worsening of Seizures
Worsening of seizures was summarized by the incidence of participants with doubling in total seizure frequency, doubling in frequency of major seizures (generalized tonic-clonic, drop attacks), or occurrence of new seizure type during each successive 3 to 4 month visit interval of the Maintenance Period relative to baseline.
Time frame: Baseline up to End of Treatment Period (up to approximately Week 106)
Population: The full analysis set for other efficacy variable included randomized participants who received rufinamide or any other add-on AED of the investigator's choice and had a baseline efficacy assessment and at least 1 postbaseline efficacy assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rufinamide | Incidence of Worsening of Seizures | Doubling in total seizure frequency | 4 Participants |
| Rufinamide | Incidence of Worsening of Seizures | Doubling in frequency of major seizures | 5 Participants |
| Rufinamide | Incidence of Worsening of Seizures | Occurrence of a new seizure type | 0 Participants |
| Any Other Approved Antiepileptic Drug | Incidence of Worsening of Seizures | Doubling in total seizure frequency | 1 Participants |
| Any Other Approved Antiepileptic Drug | Incidence of Worsening of Seizures | Doubling in frequency of major seizures | 1 Participants |
| Any Other Approved Antiepileptic Drug | Incidence of Worsening of Seizures | Occurrence of a new seizure type | 0 Participants |
Other Pre-specified
Percent Change in Seizure Frequency by Individual Seizure Type Per 28 Days
The frequency per 28 days was defined as (S/D)\*28 where, S was equal to the sum of the seizures reported in the participant seizure diary during the specified time interval and D was equal to the number of days with non-missing data in the participant seizure diary for the specified study phase. The number of seizures was assessed and recorded by the participant's parent(s)/caregiver(s) in the participant seizure diary.
Time frame: Baseline up to End of Treatment Period (up to approximately Week 106)
Population: The full analysis set for other efficacy variable included randomized participants who received rufinamide or any other add-on AED of the investigator's choice and had a baseline efficacy assessment and at least 1 postbaseline efficacy assessment. Participants evaluable for this outcome measure at given time period were included for assessment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Rufinamide | Percent Change in Seizure Frequency by Individual Seizure Type Per 28 Days | Partial seizures | -39.8 percent change in seizure frequency |
| Rufinamide | Percent Change in Seizure Frequency by Individual Seizure Type Per 28 Days | Absence seizures | -23.6 percent change in seizure frequency |
| Rufinamide | Percent Change in Seizure Frequency by Individual Seizure Type Per 28 Days | Atypical absence seizures | -70.95 percent change in seizure frequency |
| Rufinamide | Percent Change in Seizure Frequency by Individual Seizure Type Per 28 Days | Myoclonic seizures | -24.60 percent change in seizure frequency |
| Rufinamide | Percent Change in Seizure Frequency by Individual Seizure Type Per 28 Days | Clonic seizures | -60.85 percent change in seizure frequency |
| Rufinamide | Percent Change in Seizure Frequency by Individual Seizure Type Per 28 Days | Tonic-atonic seizures | -35.20 percent change in seizure frequency |
| Rufinamide | Percent Change in Seizure Frequency by Individual Seizure Type Per 28 Days | Primary generalized tonic-clonic seizures | -97.80 percent change in seizure frequency |
| Rufinamide | Percent Change in Seizure Frequency by Individual Seizure Type Per 28 Days | Other seizures | -90.65 percent change in seizure frequency |
| Any Other Approved Antiepileptic Drug | Percent Change in Seizure Frequency by Individual Seizure Type Per 28 Days | Other seizures | -100.00 percent change in seizure frequency |
| Any Other Approved Antiepileptic Drug | Percent Change in Seizure Frequency by Individual Seizure Type Per 28 Days | Partial seizures | -57.65 percent change in seizure frequency |
| Any Other Approved Antiepileptic Drug | Percent Change in Seizure Frequency by Individual Seizure Type Per 28 Days | Clonic seizures | -48.35 percent change in seizure frequency |
| Any Other Approved Antiepileptic Drug | Percent Change in Seizure Frequency by Individual Seizure Type Per 28 Days | Absence seizures | -49.70 percent change in seizure frequency |
| Any Other Approved Antiepileptic Drug | Percent Change in Seizure Frequency by Individual Seizure Type Per 28 Days | Primary generalized tonic-clonic seizures | -96.60 percent change in seizure frequency |
| Any Other Approved Antiepileptic Drug | Percent Change in Seizure Frequency by Individual Seizure Type Per 28 Days | Atypical absence seizures | 4.90 percent change in seizure frequency |
| Any Other Approved Antiepileptic Drug | Percent Change in Seizure Frequency by Individual Seizure Type Per 28 Days | Tonic-atonic seizures | -31.80 percent change in seizure frequency |
| Any Other Approved Antiepileptic Drug | Percent Change in Seizure Frequency by Individual Seizure Type Per 28 Days | Myoclonic seizures | -27.90 percent change in seizure frequency |
Other Pre-specified
Percent Change in Total Seizure Frequency Per 28 Days
The frequency per 28 days was defined as (S/D)\*28 where, S was equal to the sum of the seizures reported in the participant seizure diary during the specified time interval and D was equal to the number of days with non-missing data in the participant seizure diary for the specified study phase. The number of seizures was assessed and recorded by the participant's parent(s)/caregiver(s) in the participant seizure diary.
Time frame: Baseline up to End of the Treatment Period (up to approximately Week 106)
Population: The full analysis set for other efficacy variable included randomized participants who received rufinamide or any other add-on AED of the investigator's choice and had a baseline efficacy assessment and at least 1 postbaseline efficacy assessment. Participants evaluable for this outcome measure at given time period were included for assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rufinamide | Percent Change in Total Seizure Frequency Per 28 Days | -7.05 percent change in seizure frequency |
| Any Other Approved Antiepileptic Drug | Percent Change in Total Seizure Frequency Per 28 Days | -20.15 percent change in seizure frequency |
Other Pre-specified
Time to Withdrawal From Treatment Due to an Adverse Event or Lack of Efficacy
Withdrawal from either rufinamide or other AED was due to the occurrence of an adverse event or for lack of efficacy. Data was obtained till Week 106 and was extrapolated using Kaplan-Meier method to determine the overall survival time (in weeks) to withdrawal from treatment (excluding taper) due to an adverse event or lack efficacy.
Time frame: Baseline up to the End of the Treatment Period (up to approximately Week 106)
Population: The full analysis set for other efficacy variable included randomized participants who received rufinamide or any other add-on AED of the investigator's choice and had a baseline efficacy assessment and at least 1 post baseline efficacy assessment. Participants who were evaluable at a given time point were included for this assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rufinamide | Time to Withdrawal From Treatment Due to an Adverse Event or Lack of Efficacy | 142.0 weeks |
| Any Other Approved Antiepileptic Drug | Time to Withdrawal From Treatment Due to an Adverse Event or Lack of Efficacy | 28.0 weeks |