A Phase 3 interventional study of Rufinamide in Lennox-Gastaut Syndrome, sponsored by Eisai Co., Ltd.. Completed at 23 sites in Japan. Open to participants aged 4 Years to 30 Years. Per ClinicalTrials.gov, last updated 2019-03-11.
Sponsored by Eisai Co., Ltd. · Phase 3, Interventional, and Treatment
To investigate the safety of long term administration of E2080 in the patients with Lennox-Gastaut syndrome who completed the E2080-J081-304 Study.
64 studies on the registry are indexed under Lennox Gastaut Syndrome; 14 are open to participants now.
This study's enrollment of 54 is above the median of 41 across 46 interventional studies indexed under Lennox Gastaut Syndrome.
Browse Lennox Gastaut Syndrome studies →Eisai Co., Ltd. is the lead sponsor of 149 studies on the registry; 5 are open to participants now.
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Ralfinamide was administered orally twice daily after breakfast and dinner. Participants on placebo in Study 304 were titrated over to rufinamide within 2 weeks during the Conversion Period. As a general rule, the dose of rufinamide at the end of the Conversion Period was maintained throughout the Maintenance Period.
Drug: Rufinamide
The target dosage is approximately 45 mg/kg/day, taken orally twice a day.
Also known as: E2080, BANZEL
Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Rufinamide
Safety was assessed by monitoring and recording all adverse events (AEs), serious adverse events (SAEs), clinical laboratory tests, blood pressure, pulse rate, physical examination, and 12-lead electrocardiogram (ECG). Treatment-emergent adverse events (TEAEs) were defined as AEs that started on or after the date and time of administration of first dose of test drug, but not later than 30 days after discontinuation from the study, or if the AE was present prior to the administration of the first dose of test drug and increased in National Cancer Institute Common Toxicity Criteria (NCI CTC version 3.0) grade during the study or 30 days after discontinuation from the study. AEs were considered serious if it resulted in; death, was life-threatening, hospitalization/prolonged hospitalization, persistent or significant disability/incapacity, or a congenital anomaly/birth defect.
Time frame: From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 years 10 months
Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days)
The sum of the frequencies of tonic seizures and atonic seizures was defined as the "tonic-atonic seizure frequency". The percent change in tonic-atonic seizure frequency was calculated using the tonic-atonic seizure frequency per 28 days of the Observation Period in Study 304 as the baseline and the tonic-atonic seizure frequency at Weeks 12, 24, 32, 40, 52 and Week 52 Last Observation Carried Forward (LOCF) as the post-treatment value. Percentage change in tonic - atonic seizure frequency was calculated as follows: \[100 x (post-treatment value - baseline)/ baseline\]. The frequency of epileptic seizures was recorded in the seizure diary by the recorder. Seizure frequency was counted based on the classification established by the International League Against Epilepsy (ILAE). The diary recorder monitored the participant and recorded the seizure diary in a consistent manner, and continued these practices throughout the study period.
Time frame: Baseline (Observation period in Study 304), Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF
Percent Change in the Total Seizure Frequency From Baseline (Per 28 Days)
Percent change in the total seizure frequency (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period of Study 304 as the baseline and the total seizure frequency per 28 days at Weeks 12, 24, 32, 40, 52 and Week 52 LOCF as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: \[100 x (post-treatment value - baseline)/ baseline\].
Time frame: Baseline (Observation period in Study 304), Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF
Percent Change in the Frequency of Seizures Other Than Tonic-Atonic Seizures
Percent change in the frequency of seizures other than tonic-atonic seizures (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period as the baseline and the total seizure frequency per 28 days of the Weeks, 12, 24, 32, 40, 52 and 52 LOCF as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: \[100 x (post-treatment value - baseline)/ baseline\]. Seizures analyzed other than tonic-atonic seizures included: Partial seizure frequency, Absence seizure, Atypical absence seizure, Myoclonic seizure, Tonic seizure, Tonic-clonic seizure, Atonic seizure, and Unclassified epileptic seizure. This data was based on the diary data collected for 7 days after each visit. Seizure frequency was counted based on the classification established by the ILAE. The diary recorder monitored the participant and recorded the seizure diary in a consistent manner.
Time frame: Baseline (Observation period in Study 304), Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF
Percentage of Participants Who Achieved 100%, 75%, 50% or 25% Reduction in Tonic-Atonic Seizure Frequency (Responders)
Categorized percent change in Tonic-atonic seizure frequency per 28 Days by visit relative to the baseline (Observation Phase in Study 304) was determined based on the diary data collected for 7 days after each visit. The Efficacy Analysis Set was used.
Time frame: Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF
Percentage of Participants With An Increase In Tonic-Atonic Seizure Frequency
Number of participants with an increase in Tonic-atonic seizure frequency per 28 Days by visit relative to the baseline (Observation Phase in Study 304) was determined based on the diary data collected for 7 days after each visit. The Efficacy Analysis Set was used.
Time frame: Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF
| Milestone | Rufinamide |
|---|---|
| Started | 54 |
| Completed | 41 |
| Not completed | 13 |
| Withdrew: Other | 2 |
| Withdrew: Adverse event, non-fatal | 4 |
| Withdrew: Withdrawal by subject | 7 |
Safety was assessed by monitoring and recording all adverse events (AEs), serious adverse events (SAEs), clinical laboratory tests, blood pressure, pulse rate, physical examination, and 12-lead electrocardiogram (ECG). Treatment-emergent adverse events (TEAEs) were defined as AEs that started on or after the date and time of administration of first dose of test drug, but not later than 30 days after discontinuation from the study, or if the AE was present prior to the administration of the first dose of test drug and increased in National Cancer Institute Common Toxicity Criteria (NCI CTC version 3.0) grade during the study or 30 days after discontinuation from the study. AEs were considered serious if it resulted in; death, was life-threatening, hospitalization/prolonged hospitalization, persistent or significant disability/incapacity, or a congenital anomaly/birth defect.
| Participants | Rufinamide |
|---|---|
| TEAEs | 54 |
| Treatment-related TEAEs | 38 |
| SAEs | 9 |
| Treatment-related SAEs | 2 |
| AEs leading to study drug withdrawal | 3 |
| AEs leading to study drug dose reduction | 12 |
The sum of the frequencies of tonic seizures and atonic seizures was defined as the "tonic-atonic seizure frequency". The percent change in tonic-atonic seizure frequency was calculated using the tonic-atonic seizure frequency per 28 days of the Observation Period in Study 304 as the baseline and the tonic-atonic seizure frequency at Weeks 12, 24, 32, 40, 52 and Week 52 Last Observation Carried Forward (LOCF) as the post-treatment value. Percentage change in tonic - atonic seizure frequency was calculated as follows: \[100 x (post-treatment value - baseline)/ baseline\]. The frequency of epileptic seizures was recorded in the seizure diary by the recorder. Seizure frequency was counted based on the classification established by the International League Against Epilepsy (ILAE). The diary recorder monitored the participant and recorded the seizure diary in a consistent manner, and continued these practices throughout the study period.
| Percent Change in Seizure Frequency | Rufinamide |
|---|---|
| Percent Change in Week 12 | -39.3 (-100 to 125.2) |
| Percent Change in Week 24 | -40.6 (-100 to 85.7) |
| Percent Change in Week 32 | -46.8 (-100 to 75) |
| Percent Change in Week 40 | -47.6 (-100 to 833.2) |
| Percent Change in Week 52 | -36.05 (-100 to 101.7) |
| Percent Change in Week 52 LOCF | -39.25 (-100 to 101.7) |
Percent change in the total seizure frequency (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period of Study 304 as the baseline and the total seizure frequency per 28 days at Weeks 12, 24, 32, 40, 52 and Week 52 LOCF as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: \[100 x (post-treatment value - baseline)/ baseline\].
| Percent Change in Seizure Frequency | Rufinamide |
|---|---|
| Percent Change in Week 12 | -47.7 (-100 to 101.5) |
| Percent Change in Week 24 | -48.9 (-97 to 116.6) |
| Percent Change in Week 32 | -50.6 (-90.8 to 209.2) |
| Percent Change in Week 40 | -52 (-95.5 to 833.2) |
| Percent Change in Week 52 | -47.35 (-94.3 to 340.8) |
| Percent Change in Week 52 LOCF | -46.3 (-100 to 340.8) |
Percent change in the frequency of seizures other than tonic-atonic seizures (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period as the baseline and the total seizure frequency per 28 days of the Weeks, 12, 24, 32, 40, 52 and 52 LOCF as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: \[100 x (post-treatment value - baseline)/ baseline\]. Seizures analyzed other than tonic-atonic seizures included: Partial seizure frequency, Absence seizure, Atypical absence seizure, Myoclonic seizure, Tonic seizure, Tonic-clonic seizure, Atonic seizure, and Unclassified epileptic seizure. This data was based on the diary data collected for 7 days after each visit. Seizure frequency was counted based on the classification established by the ILAE. The diary recorder monitored the participant and recorded the seizure diary in a consistent manner.
| Percent Change in Seizure Frequency | Rufinamide |
|---|---|
| Partial Seizure Week 12 | -95 (-100 to 255.6) |
| Partial Seizure Week 24 | -80.9 (-100 to 303.2) |
| Partial Seizure Week 32 | -70.5 (-100 to 30.2) |
| Partial Seizure Week 40 | -85.7 (-100 to -42.4) |
| Partial Seizure Week 52 | -77.3 (-100 to -61.8) |
| Partial Seizure Week 52 LOCF | -77.3 (-100 to 189.2) |
| Absence Seizure Week 12 | -87.7 (-87.7 to -87.7) |
| Absence Seizure Week 24 | -100 (-100 to -100) |
| Absence Seizure Week 32 | -100 (-100 to -100) |
| Absence Seizure Week 40 | -100 (-100 to -100) |
| Absence Seizure Week 52 | -100 (-100 to -100) |
| Absence Seizure Week 52 LOCF | -100 (-100 to -100) |
| Atypical Absence Seizure Week 12 | -86.7 (-100 to 54.7) |
| Atypical Absence Seizure Week 24 | -92.85 (-100 to 185.7) |
| Atypical Absence Seizure Week 32 | -92.3 (-100 to 209.2) |
| Atypical Absence Seizure Week 40 | -100 (-100 to 219.3) |
| Atypical Absence Seizure Week 52 | -100 (-100 to 737.2) |
| Atypical Absence Seizure Week 52 LOCF | -100 (-100 to 737.2) |
| Myoclonic Seizure Week 12 | -100 (-100 to 228.8) |
| Myoclonic Seizure Week 24 | -100 (-100 to 64.4) |
| Myoclonic Seizure Week 32 | -100 (-100 to 435.6) |
| Myoclonic Seizure Week 40 | -100 (-100 to 117.6) |
| Myoclonic Seizure Week 52 | -100 (-100 to 368.2) |
| Myoclonic Seizure Week 52 LOCF | -100 (-100 to 368.2) |
| Tonic Seizure Week 12 | -35.4 (-100 to 175.2) |
| Tonic Seizure Week 24 | -37.85 (-100 to 138.5) |
| Tonic Seizure Week 32 | -49.4 (-100 to 83.5) |
| Tonic Seizure Week 40 | -47.05 (-100 to 833.2) |
| Tonic Seizure Week 52 | -36.4 (-100 to 110.2) |
| Tonic Seizure Week 52 LOCF | -46.2 (-100 to 110.2) |
| Tonic-clonic Seizure Week 12 | -61.55 (-100 to 300) |
| Tonic-clonic Seizure Week 24 | -44.1 (-100 to 300) |
| Tonic-clonic Seizure Week 32 | -22.6 (-100 to 700) |
| Tonic-clonic Seizure Week 40 | -46.7 (-100 to 1100) |
| Tonic-clonic Seizure Week 52 | -35.5 (-100 to 700) |
| Tonic-clonic Seizure Week 52 LOCF | -38.1 (-100 to 700) |
| Atonic Seizure Week 12 | -60.35 (-100 to 29) |
| Atonic Seizure Week 24 | -84.3 (-100 to 189.2) |
| Atonic Seizure Week 32 | -100 (-100 to 20.5) |
| Atonic Seizure Week 40 | -67.2 (-100 to 261.4) |
| Atonic Seizure Week 52 | -67.55 (-100 to 526.5) |
| Atonic Seizure Week 52 LOCF | -67.55 (-100 to 526.5) |
| Unclassified Seizure Week 12 | -100 (-100 to -100) |
| Unclassified Seizure Week 24 | 6932.3 (6932.3 to 6932.3) |
| Unclassified Seizure Week 32 | -100 (-100 to -100) |
| Unclassified Seizure Week 40 | -100 (-100 to -100) |
| Unclassified Seizure Week 52 | -100 (-100 to -100) |
| Unclassified Seizure Week 52 LOCF | -100 (-100 to -100) |
Categorized percent change in Tonic-atonic seizure frequency per 28 Days by visit relative to the baseline (Observation Phase in Study 304) was determined based on the diary data collected for 7 days after each visit. The Efficacy Analysis Set was used.
| Percentage of participants | Rufinamide |
|---|---|
| Week 12 100% Reduction - Yes | 6.5 |
| Week 12 100% Reduction - No | 93.5 |
| Week 12 75% Reduction - Yes | 17.4 |
| Week 12 75% Reduction - No | 82.6 |
| Week 12 50% Reduction - Yes | 43.5 |
| Week 12 50% Reduction - No | 56.5 |
| Week 12 25% Reduction - Yes | 71.7 |
| Week 12 25% Reduction - No | 28.3 |
| Week 24 100% Reduction - Yes | 2.3 |
| Week 24 100% Reduction - No | 97.7 |
| Week 24 75% Reduction - Yes | 11.6 |
| Week 24 75% Reduction - No | 88.4 |
| Week 24 50% Reduction - Yes | 39.5 |
| Week 24 50% Reduction -No | 60.5 |
| Week 24 25% Reduction - Yes | 65.1 |
| Week 24 25% Reduction - No | 34.9 |
| Week 32 100% Reduction - Yes | 2.4 |
| Week 32 100% Reduction - No | 97.6 |
| Week 32 75% Reduction - Yes | 19 |
| Week 32 75% Reduction - No | 81 |
| Week 32 50% Reduction - Yes | 47.6 |
| Week 32 50% Reduction - No | 52.4 |
| Week 32 25% Reduction - Yes | 66.7 |
| Week 32 25% Reduction - No | 33.3 |
| Week 40 100% Reduction - Yes | 4.9 |
| Week 40 100% Reduction - No | 95.1 |
| Week 40 75% Reduction - Yes | 17.1 |
| Week 40 75% Reduction - No | 82.9 |
| Week 40 50% Reduction - Yes | 48.8 |
| Week 40 50% Reduction - No | 51.2 |
| Week 40 25% Reduction - Yes | 61 |
| Week 40 25% Reduction - No | 39 |
| Week 52 100% Reduction - Yes | 5 |
| Week 52 100% Reduction - No | 95 |
| Week 52 75% Reduction - Yes | 20 |
| Week 52 75% Reduction -No | 80 |
| Week 52 50% Reduction - Yes | 37.5 |
| Week 52 50% Reduction - No | 62.5 |
| Week 52 25% Reduction - Yes | 60 |
| Week 52 25% Reduction - No | 40 |
| Week 52 (LOCF) 100% Reduction - Yes | 8.7 |
| Week 52 (LOCF) 100% Reduction - No | 91.3 |
| Week 52 (LOCF) 75% Reduction - Yes | 21.7 |
| Week 52 (LOCF) 75% Reduction -No | 78.3 |
| Week 52 (LOCF) 50% Reduction - Yes | 39.1 |
| Week 52 (LOCF) 50% Reduction - No | 60.9 |
| Week 52 (LOCF) 25% Reduction - Yes | 63 |
| Week 52 (LOCF) 25% Reduction - No | 37 |
Number of participants with an increase in Tonic-atonic seizure frequency per 28 Days by visit relative to the baseline (Observation Phase in Study 304) was determined based on the diary data collected for 7 days after each visit. The Efficacy Analysis Set was used.
| Percentage of participants | Rufinamide |
|---|---|
| Week 12 Increase - Yes | 21.7 |
| Week 12 Increase - No | 78.3 |
| Week 24 Increase - Yes | 23.3 |
| Week 24 Increase - No | 76.7 |
| Week 32 Increase - Yes | 16.7 |
| Week 32 Increase - No | 83.3 |
| Week 40 Increase - Yes | 9.8 |
| Week 40 Increase - No | 90.2 |
| Week 52 Increase - Yes | 22.5 |
| Week 52 Increase -No | 77.5 |
| Week 52 LOCF Increase - Yes | 19.6 |
| Week 52 LOCF Increase - No | 80.4 |
Collected over From date of first dose up to 15 days after the last dose of study treatment, up to approximately 2 years and 10 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rufinamide | 0/54 (0%) | 9/54 (16.7%) | 54/54 (100%) |
| Event | Rufinamide |
|---|---|
| PneumoniaInfections and infestations | 4/54 |
| Status epilepticusNervous system disorders | 2/54 |
| ContusionInjury, poisoning and procedural complications | 1/54 |
| Dental cariesGastrointestinal disorders | 1/54 |
| Upper respiratory tract infectionInfections and infestations | 1/54 |
| InfluenzaInfections and infestations | 1/54 |
| Gastroenteritis viralInfections and infestations | 1/54 |
| Event | Rufinamide |
|---|---|
| NasopharyngitisInfections and infestations | 26/54 |
| Status epilepticusNervous system disorders | 22/54 |
| SomnolenceNervous system disorders | 14/54 |
| VomitingGastrointestinal disorders | 13/54 |
| ContusionInjury, poisoning and procedural complications | 12/54 |
| InfluenzaInfections and infestations | 11/54 |
| ConstipationGastrointestinal disorders | 9/54 |
| Dental cariesGastrointestinal disorders | 7/54 |
| Decreased appetiteMetabolism and nutrition disorders | 7/54 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 6/54 |
Safety analysis set included all treated participants.
| Age, Continuous(Years) | Rufinamide |
|---|---|
| Mean | 15 ± 6.8 |
| Age, Customized(Participants) | Rufinamide |
|---|---|
| ≥4 to <12 years | 22 |
| ≥12 to <17 years | 11 |
| ≥17 years | 21 |
| Sex: Female, Male(Participants) | Rufinamide |
|---|---|
| Female | 21 |
| Male | 33 |
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Eisai Co., Ltd.