Trial · NCT00735397
Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
NCT00735397, Phase 3, Completed, Eisai Inc.; results first posted 2016-01-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures. Trials, record NCT00735397. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00735397
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
- NCT number
- NCT00735397
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,218 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Epilepsy
- Interventions
- perampanel
- First posted
- 2008-08-14
- Last updated
- 2016-03-14
- Results first posted
- 2016-01-26
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Non-Serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs) | From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years. | An AE was defined as any untoward medical occurrence in a clinical investigation participant administered with an investigational product. A SAE was defined as any untoward medical occurrence that at any dose; resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious or non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed. |
| Secondary | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Pre-perampanel Baseline and Weeks (1-13, 14-26, 27-39, 40-52, 53-65, 66-78, 79-91, 92-104, 105-117, 118-130, 131-143, 144-156, 157-169, 170-182, 183-195, 196-208, 209-221, 222-234, 235-247, and 248-260) | Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated as the number of seizures divided by the number of days in the interval and multiplied by 28. The percent change in 28-day seizure frequency from pre-perampanel baseline was assessed for all partial-onset seizure types. The pre-perampanel baseline was defined as: (1) for participants who had been assigned to placebo treatment in the core DB study, the pre-perampanel baseline was computed from all data during the core DB study, and (2) for participants who had been assigned to perampanel in the core DB study, the pre-perampanel baseline was computed from the pre-randomization phase of the core DB study. |
| Secondary | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Pre-perampanel Baseline and Weeks (1-13, 14-26, 27-39, 40-52, 53-65, 66-78, 79-91, 92-104, 105-117, 118-130, 131-143, 144-156, 157-169, 170-182, 183-195, 196-208, 209-221, 222-234, 235-247, 248-260) | Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The percentage of participants who experienced a 50% or greater reduction in seizure frequency per 28 days relative to the pre-perampanel Baseline(responders) was assessed. The pre-perampanel baseline was defined as: (1) for participants who had been assigned to placebo treatment in the core DB study, the Pre-perampanel baseline was computed from all data during the core Double-Blind (DB) study, and (2) for participants who had been assigned to perampanel in the core DB study, the pre-perampanel baseline was computed from the pre-randomization phase of the core DB study. The data is presented as percent responders. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Non-Serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs) | From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years. | The safety analysis set (SAS) was defined as participants who provided informed consent for the OLE study, received at least 1 dose of perampanel in the OLE study, and had at least 1 postdose safety assessment in the OLE study. | participants | NUMBER |
| SECONDARY | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Pre-perampanel Baseline and Weeks (1-13, 14-26, 27-39, 40-52, 53-65, 66-78, 79-91, 92-104, 105-117, 118-130, 131-143, 144-156, 157-169, 170-182, 183-195, 196-208, 209-221, 222-234, 235-247, and 248-260) | Full Intent-to-treat population (ITT), defined as participants who provided informed consent for the OLE, received at least 1 dose of perampanel in the OLE, and had valid seizure data for overall, Complex Partial Plus Secondarily Generalized Seizures and Secondarily Generalized Seizures arm, respectively during the perampanel treatment duration. | Percent change | MEDIAN |
| SECONDARY | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Pre-perampanel Baseline and Weeks (1-13, 14-26, 27-39, 40-52, 53-65, 66-78, 79-91, 92-104, 105-117, 118-130, 131-143, 144-156, 157-169, 170-182, 183-195, 196-208, 209-221, 222-234, 235-247, 248-260) | Full Intent-to-treat population (ITT), defined as participants who provided informed consent for the OLE, received at least 1 dose of perampanel in the OLE, and had valid seizure data for overall, Complex Partial Plus Secondarily Generalized Seizures and Secondarily Generalized Seizures arm, respectively during the perampanel treatment duration. | Percent responders | NUMBER |
Source ClinicalTrials.gov
Results by group122
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Non-Serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs) | Perampanel | Treatment-emergent non serious AEs | 1018 | participants | |
| Number of Participants With Treatment-emergent Non-Serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs) | Perampanel | Treatment-emergent SAEs | 288 | participants | |
| Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Overall | Weeks 1-13 | -29.14 | Full Range -100.0 to 737.1 | Percent change |
| Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Complex Partial Plus Secondarily Generalized Seizures | Weeks 1-13 | -32.42 | Full Range -100.0 to 14858.2 | Percent change |
| Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Secondarily Generalized Seizures | Weeks 1-13 | -54.95 | Full Range -100.0 to 530.8 | Percent change |
| Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Overall | Weeks 14-26, n = 1159, 1073, 482 | -38.54 | Full Range -100.0 to 866.6 | Percent change |
| Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Complex Partial Plus Secondarily Generalized Seizures | Weeks 14-26, n = 1159, 1073, 482 | -43.19 | Full Range -100.0 to 12965.9 | Percent change |
| Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Secondarily Generalized Seizures | Weeks 14-26, n = 1159, 1073, 482 | -65.69 | Full Range -100.0 to 628.6 | Percent change |
| Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Overall | Wekks 27-39, n = 1088, 1011, 458 | -42.81 | Full Range -100.0 to 780.6 | Percent change |
| Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Complex Partial Plus Secondarily Generalized Seizures | Wekks 27-39, n = 1088, 1011, 458 | -46.22 | Full Range -100.0 to 14092.3 | Percent change |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Perampanel | 1,218 | |
| Overall Study | COMPLETED | Perampanel | 35 | |
| Overall Study | NOT COMPLETED | Perampanel | 1,183 |
Source ClinicalTrials.gov
Adverse events286
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 | Fall | Injury, poisoning and procedural complications | Perampanel | 116 | 1,216 | |
| other | Laceration | Injury, poisoning and procedural complications | Perampanel | 67 | 1,216 | |
| other | Weight increased | Investigations | Perampanel | 161 | 1,216 | |
| other | Ataxia | Nervous system disorders | Perampanel | 84 | 1,216 | |
| other | Balance disorder | Nervous system disorders | Perampanel | 74 | 1,216 | |
| other | Convulsion | Nervous system disorders | Perampanel | 78 | 1,216 | |
| other | Dizziness | Nervous system disorders | Perampanel | 591 | 1,216 | |
| other | Dysarthria | Nervous system disorders | Perampanel | 61 | 1,216 | |
| other | Headache | Nervous system disorders | Perampanel | 246 | 1,216 | |
| other | Somnolence | Nervous system disorders | Perampanel | 266 | 1,216 |
1 to 10 of 286Source ClinicalTrials.gov
See all 286 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Perampanel | ||
| Total, other adverse events | Perampanel | 1,018 | 1,216 |
| Total, serious adverse events | Perampanel | 288 | 1,216 |
Source ClinicalTrials.gov
Papers4
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 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.
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/NCT00735397
GET https://conductscience.org/api/trials/v1/NCT00735397/results?page=2