Trial · NCT02834793
Study of Perampanel as Adjunctive Treatment for Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome
NCT02834793, Phase 3, Terminated, Eisai Inc.; results first posted 2022-03-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Perampanel as Adjunctive Treatment for Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome. Trials, record NCT02834793. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02834793
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Perampanel as Adjunctive Treatment for Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome
- NCT number
- NCT02834793
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 101 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Lennox-Gastaut Syndrome (LGS)
- Interventions
- Placebo, Perampanel
- First posted
- 2016-07-15
- Last updated
- 2022-03-09
- Other registries' IDs
- eudract:2014-002321-35
- Results first posted
- 2022-03-09
- Limitations and caveats
Study was terminated early by sponsor due to recruitment challenge, further impacted by COVID19, resulting in reduced sample size and variability in treatment response. Population PK analysis and PK/PD modeling planned for this study were not conducted and hence data was not collected and analyzed.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Core Study Phase: Median Percent Change in Drop Seizure Frequency Per 28 Days During Double-blind Treatment Relative to the Prerandomization Phase (Baseline) | Baseline up to 18 weeks | Drop seizure was defined as a drop attack or spell involving the entire body, trunk, or head that led to a fall, injury, slumping in a chair, or the participant's head hitting a surface or that could have led to a fall or injury, depending on the participant's position at the time of the attack or spell. Seizure frequency was based on the number of drop seizures per 28 days, calculated as the number of drop seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. |
| Secondary | Core Study Phase: Median Percent Change in Total Seizure Frequency Per 28 Days During Double-blind Treatment Relative to the Prerandomization Phase (Baseline) | Baseline up to 18 weeks | Total seizure was the number of seizures assessed and recorded by the participant's parent/caregiver in the participant seizure diary. Seizure diaries were used to collect seizure counts and types. Seizure frequency was based on the number of drop seizures per 28 days, calculated as the number of drop seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. |
| Secondary | Core Study Phase: Percentage of Participants With 50% Response in the Maintenance Period of the Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) for Drop Seizures | Baseline up to 18 weeks | Drop seizure was defined as a drop attack or spell involving the entire body, trunk, or head that led to a fall, injury, slumping in a chair, or the participant's head hitting a surface or that could have led to a fall or injury, depending on the participant's position at the time of the attack or spell. A responder was a participant who experienced a 50% or greater reduction in drop seizure frequency per 28 days during Maintenance from prerandomization. |
| Secondary | Core Study Phase: Percentage of Participants With 50% Response in the Maintenance Period of the Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) for Total Seizures | Baseline up to 18 weeks | Total seizure was the number of seizures assessed and recorded by the participant's parent/caregiver in the participant seizure diary. Seizure diaries was used to collect seizure counts and types. A responder was a participant who experienced a 50% or greater reduction in drop seizure frequency per 28 days during Maintenance from prerandomization. |
| Secondary | Core Study Phase: Median Percent Change in Non-drop Seizure Frequency Per 28 Days During Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) | Baseline up to 18 weeks | Non-drop seizures were defined as non-drop attacks or spells. Drop attacks and spells involved the entire body, trunk, or head and lead to a fall, injury, slumping in a chair, or the participant's head hitting a surface, or could lead to a fall or injury, depending on the participant's position at the time of the attack or spell. Seizure frequency was based on the number of drop seizures per 28 days, calculated as the number of drop seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. |
| Secondary | Core Study Phase: Percentage of Participants With 75% Response in the Maintenance Period of the Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) for Drop Seizures, Non-drop Seizures and Total Seizures | Baseline up to 18 weeks | Drop seizure was defined as a drop attack or spell involving the entire body, trunk, or head that led to a fall, injury, slumping in a chair, or the participant's head hitting a surface or that could have led to a fall or injury, depending on the participant's position at the time of the attack or spell. Non-drop seizures were defined as non-drop attacks or spells. Total seizure was the number of seizures assessed and recorded by the participant's parent/caregiver in the participant seizure diary. Seizure diaries were used to collect seizure counts and types. A responder was a participant who experienced a 75% or greater reduction in drop seizure/non-drop seizure/ frequency per 28 days during Maintenance from prerandomization. |
| Secondary | Core Study Phase: Percentage of Participants With 100% Response in the Maintenance Period of the Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) for Drop Seizures, Non-drop Seizures and Total Seizures | Baseline up to 18 weeks | Drop seizure was defined as a drop attack or spell involving the entire body, trunk, or head that led to a fall, injury, slumping in a chair, or the participant's head hitting a surface or that could have led to a fall or injury, depending on the participant's position at the time of the attack or spell. Non-drop seizures were defined as non-drop attacks or spells. Total seizure was the number of seizures assessed and recorded by the participant's parent/caregiver in the participant seizure diary. Seizure diaries was used to collect seizure counts and types. A responder was a participant who experienced a 100% or greater reduction in drop seizure/non-drop seizure/ frequency per 28 days during Maintenance from prerandomization. |
| Secondary | Core Study Phase: Percentage of Participants With 50% Response in the Maintenance Period of the Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) for Non-drop Seizures | Baseline up to 18 weeks | Non-drop seizures were defined as non-drop attacks or spells. Drop attacks and spells involved the entire body, trunk, or head and lead to a fall, injury, slumping in a chair, or the participant's head hitting a surface, or could lead to a fall or injury, depending on the participant's position at the time of the attack or spell. A responder was a participant who experienced a 50% or greater reduction in non-drop seizure frequency per 28 days during Maintenance from prerandomization. |
| Secondary | Core Study Phase: Percentage of Participants With Clinical Global Impression of Change Scores (CGIC) in the Double-blind Treatment Phase | Baseline up to 18 weeks | Assessment of disease severity utilized the CGIC scale at end of treatment to evaluate participants change in disease status from baseline. The CGIC is a 7-point likert scale that measures a physician's global impression of a participants clinical condition. Scale ranged from 1 to 7 with lower score indicated improvement (1=very much improved, 2=much improved, 3=minimally improved), higher score indicated worsening (5=minimally worse, 6= much worse, 7=very much worse), and a score of 4 indicated no change. |
| Secondary | Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From the date of the first administration of the study drug up to 28 days after the last dose of the study drug (up to 192 weeks) | A TEAE was defined as an adverse event with an onset date, or a worsening in severity from baseline (pre-treatment), on or after the first dose of study drug up to 28 days following study drug discontinuation. An AE was defined as any untoward medical occurrence in a participant or clinical investigation in a participant administered an investigational product. An AE does not necessarily have a causal relationship with a medicinal product. A serious adverse event (SAE) was defined as any AE if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Core Study Phase: Median Percent Change in Drop Seizure Frequency Per 28 Days During Double-blind Treatment Relative to the Prerandomization Phase (Baseline) | Baseline up to 18 weeks | The full analysis set (FAS) was the group of randomized participants who received at least one dose of the study drug and had at least one post-dose seizure measurement. | percent change | MEDIAN |
| SECONDARY | Core Study Phase: Median Percent Change in Total Seizure Frequency Per 28 Days During Double-blind Treatment Relative to the Prerandomization Phase (Baseline) | Baseline up to 18 weeks | The FAS was the group of randomized participants who received at least one dose of the study drug and had at least one post-dose seizure measurement. | percent change | MEDIAN |
| SECONDARY | Core Study Phase: Percentage of Participants With 50% Response in the Maintenance Period of the Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) for Drop Seizures | Baseline up to 18 weeks | The FAS was the group of randomized participants who received at least one dose of the study drug and had at least one post-dose seizure measurement. | percentage of participants | NUMBER |
| SECONDARY | Core Study Phase: Percentage of Participants With 50% Response in the Maintenance Period of the Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) for Total Seizures | Baseline up to 18 weeks | The FAS was the group of randomized participants who received at least one dose of study drug and had at least one post-dose seizure measurement. | percentage of participants | NUMBER |
| SECONDARY | Core Study Phase: Median Percent Change in Non-drop Seizure Frequency Per 28 Days During Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) | Baseline up to 18 weeks | The FAS was the group of randomized participants who received at least one dose of study drug and had at least one post-dose seizure measurement. Here overall number of participants analyzed were participants who were evaluable for this outcome measure. | percent change | MEDIAN |
| SECONDARY | Core Study Phase: Percentage of Participants With 75% Response in the Maintenance Period of the Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) for Drop Seizures, Non-drop Seizures and Total Seizures | Baseline up to 18 weeks | The FAS was the group of randomized participants who received at least one dose of the study drug and had at least one post-dose seizure measurement. Here number analyzed were participants who were evaluable for the outcome measure at given categories. | percentage of participants | NUMBER |
| SECONDARY | Core Study Phase: Percentage of Participants With 100% Response in the Maintenance Period of the Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) for Drop Seizures, Non-drop Seizures and Total Seizures | Baseline up to 18 weeks | The FAS was the group of randomized participants who received at least one dose of the study drug and had at least one post-dose seizure measurement. Here number analyzed were participants who were evaluable for the outcome measure at given categories. | percentage of participants | NUMBER |
| SECONDARY | Core Study Phase: Percentage of Participants With 50% Response in the Maintenance Period of the Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) for Non-drop Seizures | Baseline up to 18 weeks | The FAS was the group of randomized participants who received at least one dose of the study drug and had at least one post-dose seizure measurement. Here overall number of participants analyzed were participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Core Study Phase: Percentage of Participants With Clinical Global Impression of Change Scores (CGIC) in the Double-blind Treatment Phase | Baseline up to 18 weeks | The FAS was the group of randomized participants who received at least one dose of study drug and had at least one post-dose seizure measurement. Here overall number of participants analyzed were participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From the date of the first administration of the study drug up to 28 days after the last dose of the study drug (up to 192 weeks) | SAS was group of participants who received at least one dose of study drug and had at least one post-dose safety assessment. As per the planned safety analysis, safety data for Extension A and Extension B was reported together as 'Extension Phase' arm. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group104
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Core Study Phase: Median Percent Change in Drop Seizure Frequency Per 28 Days During Double-blind Treatment Relative to the Prerandomization Phase (Baseline) | Core Study Phase: Placebo | -4.51 | Full Range -86.2 to 201.8 | percent change | |
| Core Study Phase: Median Percent Change in Drop Seizure Frequency Per 28 Days During Double-blind Treatment Relative to the Prerandomization Phase (Baseline) | Core Study Phase: Perampanel | -23.07 | Full Range -96.4 to 371.4 | percent change | |
| Core Study Phase: Median Percent Change in Total Seizure Frequency Per 28 Days During Double-blind Treatment Relative to the Prerandomization Phase (Baseline) | Core Study Phase: Placebo | -6.53 | Full Range -63.6 to 266.8 | percent change | |
| Core Study Phase: Median Percent Change in Total Seizure Frequency Per 28 Days During Double-blind Treatment Relative to the Prerandomization Phase (Baseline) | Core Study Phase: Perampanel | -18.23 | Full Range -96.9 to 103.5 | percent change | |
| Core Study Phase: Percentage of Participants With 50% Response in the Maintenance Period of the Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) for Drop Seizures | Core Study Phase: Placebo | 25.0 | percentage of participants | ||
| Core Study Phase: Percentage of Participants With 50% Response in the Maintenance Period of the Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) for Drop Seizures | Core Study Phase: Perampanel | 44.1 | percentage of participants | ||
| Core Study Phase: Percentage of Participants With 50% Response in the Maintenance Period of the Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) for Total Seizures | Core Study Phase: Placebo | 16.7 | percentage of participants | ||
| Core Study Phase: Percentage of Participants With 50% Response in the Maintenance Period of the Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) for Total Seizures | Core Study Phase: Perampanel | 32.4 | percentage of participants | ||
| Core Study Phase: Median Percent Change in Non-drop Seizure Frequency Per 28 Days During Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) | Core Study Phase: Placebo | -13.21 | Full Range -100.0 to 2288.1 | percent change | |
| Core Study Phase: Median Percent Change in Non-drop Seizure Frequency Per 28 Days During Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) | Core Study Phase: Perampanel | -12.33 | Full Range -98.7 to 63.2 | percent change |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Core Study (Up to 18 Weeks) | STARTED | Core Study Phase: Placebo | 36 | |
| Core Study (Up to 18 Weeks) | STARTED | Core Study Phase: Perampanel | 34 | |
| Core Study (Up to 18 Weeks) | STARTED | Extension Phase A: Perampanel | 0 | |
| Core Study (Up to 18 Weeks) | STARTED | Extension Phase B: Perampanel | 0 | |
| Core Study (Up to 18 Weeks) | COMPLETED | Core Study Phase: Placebo | 32 | |
| Core Study (Up to 18 Weeks) | COMPLETED | Core Study Phase: Perampanel | 29 | |
| Core Study (Up to 18 Weeks) | COMPLETED | Extension Phase A: Perampanel | 0 | |
| Core Study (Up to 18 Weeks) | COMPLETED | Extension Phase B: Perampanel | 0 | |
| Core Study (Up to 18 Weeks) | NOT COMPLETED | Core Study Phase: Placebo | 4 | |
| Core Study (Up to 18 Weeks) | NOT COMPLETED | Core Study Phase: Perampanel | 5 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events180
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 | Constipation | Gastrointestinal disorders | Core Study Phase: Placebo | 0 | 36 | 0 |
| other | Constipation | Gastrointestinal disorders | Core Study Phase: Perampanel | 2 | 34 | 2 |
| other | Constipation | Gastrointestinal disorders | Extension Phase: Perampanel | 6 | 58 | 6 |
| other | Diarrhoea | Gastrointestinal disorders | Core Study Phase: Placebo | 1 | 36 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Core Study Phase: Perampanel | 3 | 34 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Extension Phase: Perampanel | 3 | 58 | 3 |
| other | Nausea | Gastrointestinal disorders | Core Study Phase: Placebo | 0 | 36 | 0 |
| other | Nausea | Gastrointestinal disorders | Core Study Phase: Perampanel | 2 | 34 | 2 |
| other | Nausea | Gastrointestinal disorders | Extension Phase: Perampanel | 3 | 58 | 4 |
| other | Vomiting | Gastrointestinal disorders | Core Study Phase: Placebo | 5 | 36 | 5 |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Core Study Phase: Placebo | 0 | 36 |
| Total, all-cause mortality | Core Study Phase: Perampanel | 0 | 34 |
| Total, all-cause mortality | Extension Phase: Perampanel | 2 | 58 |
| Total, other adverse events | Core Study Phase: Placebo | 26 | 36 |
| Total, other adverse events | Core Study Phase: Perampanel | 29 | 34 |
| Total, other adverse events | Extension Phase: Perampanel | 50 | 58 |
| Total, serious adverse events | Core Study Phase: Placebo | 1 | 36 |
| Total, serious adverse events | Core Study Phase: Perampanel | 6 | 34 |
| Total, serious adverse events | Extension Phase: Perampanel | 11 | 58 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33825230 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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