Trial · NCT01146951
A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304)
NCT01146951, Phase 3, Completed, Eisai Limited; results first posted 2013-11-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304). Trials, record NCT01146951. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01146951
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304)
- NCT number
- NCT01146951
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 66 participants, actual
- Lead sponsor
- Eisai Limited
- Conditions
- Lennox-Gastaut Syndrome
- Interventions
- Rufinamide (E2080), Placebo
- First posted
- 2010-06-22
- Last updated
- 2018-01-24
- Results first posted
- 2013-11-21
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days) | Baseline (28 day observational period) and End of Treatment (28 day treatment period) | The sum of the frequencies of tonic seizures and atonic seizures was defined as the "tonic-atonic seizure frequency" and the percent change in tonic-atonic seizure frequency per 28 days was assessed. The percent change in tonic-atonic seizure frequency was calculated using the tonic-atonic seizure frequency per 28 days of the Observation Period as the baseline and the tonic-atonic seizure frequency per 28 days of the Treatment Period 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. |
| Secondary | Number of Participants Achieving a 50% Reduction in Tonic-atonic Seizure Frequency | 12 weeks | 50% Responder Rate in Tonic-Atonic Seizure Frequency was presented as the number of participants who achieved a 50% reduction in tonic-atonic seizure frequency. |
| Secondary | Percent Change in Total Seizure Frequency (Per 28 Days) | Baseline (28 day observational period) and End of Treatment (28 day treatment period) | Percent change in the total seizure frequency (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 Treatment Period as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: \[100 x (post-treatment value - baseline)/ baseline\]. |
| Secondary | Percentage Change in the Frequency of Seizures Other Than Tonic-atonic Seizures (Per 28 Days) | Baseline (28 day observational period) and End of Treatment (28 day treatment period) | 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 Treatment Period 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 freq. (frequency), Absence seizure, Atyp. (atypical) absence seizure, Myoclonic seizure, Clonic seizure, Tonic seizure, Tonic-clonic seizure, Atonic seizure, \& Uncla. (unclassified) epileptic seizure. The frequency of epileptic seizures was recorded in the 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. |
| Secondary | Clinical Global Impression of Change (CGIC) | Up to Week 12 of the treatment period | CGIC in participants with Lennox-Gastaut Syndrome (LGS) relative to placebo was presented as number of participants in each category at the final assessment (last observation carried forward \[LOCF\]) \& at Week 12 of the Treatment Period. The investigator assessed the CGIC by comparing the participants' condition during the 4 weeks immediately before the completion (or discontinuation \[d/c\]) of the Treatment Period to his/her condition during the 4-week Observation Period (for participants who d/c'd the study during the Treatment Period, the CGIC was assessed by comparing the participant's condition from the start to discontinuation of the study treatment to his/her condition during the 4-week Observation Period). The CGIC was assessed according to the following 7-grade scale based on the frequency \& severity of seizures, AEs, and overall conditions of daily life. Markedly improved, Improved, Slightly improved, Unchanged, Slightly worsened, Worsened, Markedly worsened. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days) | Baseline (28 day observational period) and End of Treatment (28 day treatment period) | Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.~Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment. | Percent Change | MEDIAN |
| SECONDARY | Number of Participants Achieving a 50% Reduction in Tonic-atonic Seizure Frequency | 12 weeks | Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.~Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment. | Participants | NUMBER |
| SECONDARY | Percent Change in Total Seizure Frequency (Per 28 Days) | Baseline (28 day observational period) and End of Treatment (28 day treatment period) | Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.~Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment. | Percent Change | MEDIAN |
| SECONDARY | Percentage Change in the Frequency of Seizures Other Than Tonic-atonic Seizures (Per 28 Days) | Baseline (28 day observational period) and End of Treatment (28 day treatment period) | Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.~Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment. | Percent change | MEDIAN |
| SECONDARY | Clinical Global Impression of Change (CGIC) | Up to Week 12 of the treatment period | Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.~Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days) | Rufinamide (E2080) | -24.20 | Full Range -93.5 to 27.2 | Percent Change | |
| Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days) | Placebo | -3.25 | Full Range -81.6 to 151.9 | Percent Change | |
| Number of Participants Achieving a 50% Reduction in Tonic-atonic Seizure Frequency | Rufinamide (E2080) | Yes (50% Reduction Achieved) | 7 | Participants | |
| Number of Participants Achieving a 50% Reduction in Tonic-atonic Seizure Frequency | Placebo | Yes (50% Reduction Achieved) | 2 | Participants | |
| Number of Participants Achieving a 50% Reduction in Tonic-atonic Seizure Frequency | Rufinamide (E2080) | No | 21 | Participants | |
| Number of Participants Achieving a 50% Reduction in Tonic-atonic Seizure Frequency | Placebo | No | 28 | Participants | |
| Percent Change in Total Seizure Frequency (Per 28 Days) | Rufinamide (E2080) | -32.90 | Full Range -87.3 to 15.4 | Percent Change | |
| Percent Change in Total Seizure Frequency (Per 28 Days) | Placebo | -3.05 | Full Range -52.2 to 133.0 | Percent Change | |
| Percentage Change in the Frequency of Seizures Other Than Tonic-atonic Seizures (Per 28 Days) | Rufinamide (E2080) | Partial Seizure Freq. % Change (n=4,6) | -52.20 | Full Range -96.2 to -26.3 | Percent change |
| Percentage Change in the Frequency of Seizures Other Than Tonic-atonic Seizures (Per 28 Days) | Placebo | Partial Seizure Freq. % Change (n=4,6) | 4.5 | Full Range -28.2 to 35.9 | Percent change |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rufinamide (E2080) | 29 | |
| Overall Study | STARTED | Placebo | 30 | |
| Overall Study | COMPLETED | Rufinamide (E2080) | 25 | |
| Overall Study | COMPLETED | Placebo | 29 | |
| Overall Study | NOT COMPLETED | Rufinamide (E2080) | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events100
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypothyroidism | Endocrine disorders | Rufinamide (E2080) | 1 | 29 | |
| other | Hypothyroidism | Endocrine disorders | Placebo | 0 | 30 | |
| other | Vomiting | Gastrointestinal disorders | Rufinamide (E2080) | 5 | 29 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 1 | 30 | |
| other | Dental Caries | Gastrointestinal disorders | Rufinamide (E2080) | 2 | 29 | |
| other | Dental Caries | Gastrointestinal disorders | Placebo | 0 | 30 | |
| other | Nausea | Gastrointestinal disorders | Rufinamide (E2080) | 2 | 29 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 30 | |
| other | Anal Fissure | Gastrointestinal disorders | Rufinamide (E2080) | 0 | 29 | |
| other | Anal Fissure | Gastrointestinal disorders | Placebo | 1 | 30 |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rufinamide (E2080) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Rufinamide (E2080) | 27 | 29 |
| Total, other adverse events | Placebo | 21 | 30 |
| Total, serious adverse events | Rufinamide (E2080) | 1 | 29 |
| Total, serious adverse events | Placebo | 1 | 30 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Rufinamide (E2080) vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01146951
GET https://conductscience.org/api/trials/v1/NCT01146951/results?page=2