A Phase 3 interventional study of Rufinamide and Any other approved Antiepileptic Drug in Lennox-Gastaut Syndrome, sponsored by Eisai Inc.. Completed at 47 sites in 7 countries. Open to participants aged 1 Year to 3 Years. Per ClinicalTrials.gov, last updated 2019-08-06.
Sponsored by Eisai Inc. · Phase 3, Interventional, and Treatment
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.
64 studies on the registry are indexed under Lennox Gastaut Syndrome; 14 are open to participants now.
This study's enrollment of 37 is close to the median of 41 across 46 interventional studies indexed under Lennox Gastaut Syndrome.
Browse Lennox Gastaut Syndrome studies →Eisai Inc. is the lead sponsor of 360 studies on the registry; 7 are open to participants now.
Of its 81 completed or terminated interventional studies of FDA-regulated products, 54 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion:
Key Exclusion:
Drug: Rufinamide
Drug: Any other approved Antiepileptic Drug
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)
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)
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were combined to yield scores for 8 problem area scales (emotionally reactive, anxious/depressed, somatic complaints, withdrawn, sleep problems, attention problems, aggressive behavior, and other problems) and 3 summary scores (internalizing, externalizing, and total problems).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)
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)
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)
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)
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)
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)
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
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
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
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
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.
| Milestone | Rufinamide | Any Other Approved Antiepileptic Drug |
|---|---|---|
| Started | 25 | 12 |
| Completed | 15 | 4 |
| Not completed | 10 | 8 |
| Withdrew: Adverse event | 3 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Participant choice | 2 | 1 |
| Withdrew: Inadequate therapeutic effect | 2 | 1 |
| Withdrew: Withdrawal by subject | 3 | 4 |
| Withdrew: Other | 0 | 1 |
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.
| score on a scale | Rufinamide | Any Other Approved Antiepileptic Drug |
|---|---|---|
| Child Behavior Checklist (CBCL) Total Problem T-scores at the End of 2-year Treatment Period | 55.7 ± 15.81 | 54.8 ± 4.50 |
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.
| score on a scale | Rufinamide | Any Other Approved Antiepileptic Drug |
|---|---|---|
| Baseline | 56.6 ± 11.27 | 62.8 ± 13.07 |
| Change at Week 106 | -0.3 ± 15.72 | -6.7 ± 0.58 |
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.
| weeks | Rufinamide | Any Other Approved Antiepileptic Drug |
|---|---|---|
| Time to Withdrawal From Treatment Due to an Adverse Event or Lack of Efficacy | 142.0 (NA to NA) | 28.0 (17.7 to NA) |
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 | Rufinamide | Any Other Approved Antiepileptic Drug |
|---|---|---|
| Percent Change in Total Seizure Frequency Per 28 Days | -7.05 (-79.2 to 3644.1) | -20.15 (-83.3 to 143.1) |
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 | Rufinamide | Any Other Approved Antiepileptic Drug |
|---|---|---|
| Partial seizures | -39.8 (-100.0 to 52281.9) | -57.65 (-98.1 to -17.2) |
| Absence seizures | -23.6 (-100.0 to 86.8) | -49.70 (-98.9 to 1846.7) |
| Atypical absence seizures | -70.95 (-100.0 to 16825.4) | 4.90 (-90.9 to 1189.7) |
| Myoclonic seizures | -24.60 (-73.3 to 11462.4) | -27.90 (-60.9 to 130.2) |
| Clonic seizures | -60.85 (-100.0 to 140.4) | -48.35 (-54.2 to -42.5) |
| Tonic-atonic seizures | -35.20 (-100.0 to 1250.6) | -31.80 (-81.9 to -4.0) |
| Primary generalized tonic-clonic seizures | -97.80 (-100.0 to 37.6) | -96.60 (-96.6 to -96.6) |
| Other seizures | -90.65 (-100.0 to 183.8) | -100.00 (-100.0 to -54.0) |
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.
| Participants | Rufinamide | Any Other Approved Antiepileptic Drug |
|---|---|---|
| Doubling in total seizure frequency | 4 | 1 |
| Doubling in frequency of major seizures | 5 | 1 |
| Occurrence of a new seizure type | 0 | 0 |
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.
| score on a scale | Rufinamide | Any Other Approved Antiepileptic Drug |
|---|---|---|
| Baseline: Total emotional reactive scores | 59.0 ± 8.13 | 60.9 ± 8.64 |
| Change at Week 106:Total emotional reactive scores | -1.1 ± 9.30 | -1.3 ± 6.11 |
| Baseline: Total anxious/depression scores | 56.4 ± 7.48 | 54.6 ± 6.67 |
| Change at Week 106:Total anxious/depression scores | 0.5 ± 8.87 | 0.7 ± 1.15 |
| Baseline: Total Somatic Complaints Scores | 59.4 ± 8.13 | 54.9 ± 4.70 |
| Change at Week 106:Total Somatic Complaints Scores | 0.1 ± 11.24 | -1.7 ± 2.89 |
| Baseline: Total withdrawn scores | 71.5 ± 11.72 | 72.1 ± 11.03 |
| Change at Week 106:Total withdrawn scores | -2.2 ± 13.22 | -7.0 ± 9.54 |
| Baseline: Total Sleep Problems Scores | 57.8 ± 10.72 | 62.4 ± 8.57 |
| Change at Week 106:Total sleep problem scores | -1.9 ± 12.30 | -5.7 ± 7.57 |
| Baseline: Total attention problems scores | 59.3 ± 9.17 | 65.9 ± 10.72 |
| Change at Week 106:Total attention problems scores | -1.1 ± 4.65 | -7.7 ± 2.52 |
| Baseline: Total Aggressive Behavior Scores | 52.5 ± 5.01 | 58.6 ± 12.07 |
| Change at Week106:Total aggressive behavior scores | 3.2 ± 6.26 | -0.3 ± 2.89 |
| Baseline: Total internalizing scores | 61.6 ± 10.78 | 60.6 ± 9.71 |
| Change at Week 106:Total internalizing scores | -1.5 ± 13.73 | -2.7 ± 1.53 |
| Baseline: Total externalizing scores | 47.5 ± 11.22 | 58.1 ± 15.92 |
| Change at Week 106:Total externalizing scores | 4.7 ± 10.07 | -3.7 ± 3.51 |
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.
| words | Rufinamide | Any Other Approved Antiepileptic Drug |
|---|---|---|
| Baseline: LDS average phrase length | 0.3 ± 0.87 | 0 ± 0.00 |
| Change at Week 24: LDS average phrase length | 0.2 ± 1.11 | 0.7 ± 1.28 |
| Change at Week 56: LDS average phrase length | 0.1 ± 1.02 | 0.0 ± 0.00 |
| Change at Week 88: LDS average phrase length | 0.1 ± 1.03 | 0.0 ± 0.00 |
| Change at Week 106: LDS average phrase length | 0.4 ± 1.12 | 0.0 ± 0.00 |
| Baseline:LDS Vocabulary Score | 10.4 ± 37.72 | 0.6 ± 1.67 |
| Change at Week 24:LDS Vocabulary Score | 7.1 ± 21.55 | 4.8 ± 8.22 |
| Change at Week 56:LDS Vocabulary Score | 17.9 ± 39.24 | -0.40 ± 2.15 |
| Change at Week 88:LDS Vocabulary Score | 25.4 ± 49.87 | 0.0 ± 0.00 |
| Change at Week 106:LDS Vocabulary Score | 39.6 ± 75.62 | 1.0 ± 2.00 |
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.
| score on a scale | Rufinamide | Any Other Approved Antiepileptic Drug |
|---|---|---|
| Baseline | 50.4 ± 10.05 | 49.6 ± 7.88 |
| Week 106 | -1.3 ± 8.49 | 1.5 ± 1.00 |
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.
| score on a scale | Rufinamide | Any Other Approved Antiepileptic Drug |
|---|---|---|
| Baseline: Physical restriction | 50.1 ± 10.33 | 49.9 ± 8.23 |
| Change at Week 106: Physical restriction | -1.0 ± 7.51 | -6.8 ± 7.32 |
| Baseline: Energy/Fatigue | 51.6 ± 10.48 | 44.3 ± 4.55 |
| Change at Week 106: Energy/Fatigue | -3.1 ± 12.22 | 2.8 ± 4.11 |
| Baseline: Attention/Concentration | 49.9 ± 10.14 | 51.1 ± 9.05 |
| Change at Week 106:Attention/Concentration | -2.1 ± 7.31 | 2.5 ± 6.24 |
| Baseline: Memory | 50.2 ± 9.54 | 52.6 ± 6.57 |
| Change at Week 106: Memory | -0.5 ± 12.18 | 0.5 ± 1.00 |
| Baseline: Language | 49.8 ± 10.42 | 53.1 ± 4.43 |
| Change at Week 106: Language | -0.5 ± 9.63 | -0.5 ± 11.56 |
| Baseline: Other cognitive | 48.6 ± 10.32 | 53.1 ± 7.54 |
| Change at Week 106: Other cognitive | 0.3 ± 6.19 | -1.0 ± 4.00 |
| Baseline: Depression | 51.2 ± 9.27 | 45.3 ± 10.59 |
| Change at Week 106: Depression | -2.6 ± 11.64 | 2.3 ± 8.62 |
| Baseline: Anxiety | 50.1 ± 10.27 | 48.5 ± 12.29 |
| Change at Week 106: Anxiety | -0.1 ± 12.12 | 1.3 ± 6.90 |
| Baseline: Control/Helplessness | 50.7 ± 9.31 | 47.8 ± 12.27 |
| Change at Week 106: Control/Helplessness | 0.2 ± 10.90 | 3.0 ± 11.52 |
| Baseline: Self-esteem | 50.1 ± 10.18 | 50.5 ± 10.98 |
| Change at Week 106: Self-esteem | -1.3 ± 9.48 | -6.0 ± 8.08 |
| Baseline: Social interactions | 49.9 ± 10.56 | 50.5 ± 8.48 |
| Change at Week 106: Social interactions | -1.5 ± 11.64 | 4.0 ± 5.89 |
| Baseline: Social activities | 50.5 ± 10.50 | 46.6 ± 3.96 |
| Change at Week 106: Social activities | 0.9 ± 11.30 | 3.5 ± 3.70 |
| Baseline: Stigma | 48.9 ± 11.06 | 50.7 ± 8.07 |
| Change at Week 106: Stigma | -0.1 ± 12.67 | 4.5 ± 10.25 |
| Baseline: Behavior | 51.4 ± 10.39 | 45.8 ± 9.33 |
| Change at Week 106: Behavior | 0.2 ± 5.92 | 7.3 ± 6.55 |
| Baseline: General-health | 50.5 ± 10.02 | 49.0 ± 8.40 |
| Change at Week 106: General health | -1.3 ± 10.98 | -2.0 ± 10.86 |
| Baseline: Quality-of-life | 49.5 ± 9.71 | 50.7 ± 9.98 |
| Change at Week 106: Quality-of-life | 1.1 ± 9.46 | 3.3 ± 12.28 |
Collected over From Visit 1 up to 30 days after the last study visit, or until resolution, whichever came first (up to approximately Week 106). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rufinamide | 1/25 (4%) | 10/25 (40%) | 21/25 (84%) |
| Any Other Approved Antiepileptic Drug | 0/12 (0%) | 5/12 (41.7%) | 10/12 (83.3%) |
| Event | Rufinamide | Any Other Approved Antiepileptic Drug |
|---|---|---|
| SeizureNervous system disorders | 1/25 | 3/12 |
| BronchopneumoniaInfections and infestations | 1/25 | 1/12 |
| Joint dislocationInjury, poisoning and procedural complications | 0/25 | 1/12 |
| DehydrationMetabolism and nutrition disorders | 0/25 | 1/12 |
| Muscular weaknessMusculoskeletal and connective tissue disorders | 0/25 | 1/12 |
| LethargyNervous system disorders | 0/25 | 1/12 |
| Respiratory distressRespiratory, thoracic and mediastinal disorders | 2/25 | 1/12 |
| Status epilepticusNervous system disorders | 2/25 | 0/12 |
| BlindnessEye disorders | 1/25 | 0/12 |
| BronchitisInfections and infestations | 1/25 | 0/12 |
| Event | Rufinamide | Any Other Approved Antiepileptic Drug |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 7/25 | 4/12 |
| VomitingGastrointestinal disorders | 7/25 | 1/12 |
| DiarrhoeaGastrointestinal disorders | 4/25 | 3/12 |
| PyrexiaGeneral disorders | 4/25 | 3/12 |
| SomnolenceNervous system disorders | 5/25 | 0/12 |
| CoughRespiratory, thoracic and mediastinal disorders | 4/25 | 2/12 |
| Otitis mediaInfections and infestations | 4/25 | 0/12 |
| PneumoniaInfections and infestations | 4/25 | 0/12 |
| SinusitisInfections and infestations | 4/25 | 1/12 |
| ConstipationGastrointestinal disorders | 3/25 | 1/12 |
The safety analysis set included all enrolled participants who received at least 1 dose of rufinamide or any other approved add-on AED of the investigator's choice and had at least 1 postdose safety assessment.
| Age, Continuous(months) | Rufinamide | Any Other Approved Antiepileptic Drug | Total |
|---|---|---|---|
| Mean | 28.3 ± 9.99 | 29.8 ± 9.85 | 28.8 ± 9.83 |
| Sex: Female, Male(Participants) | Rufinamide | Any Other Approved Antiepileptic Drug | Total |
|---|---|---|---|
| Female | 11 | 2 | 13 |
| Male | 14 | 10 | 24 |
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