Epilepsy
Conditions
Keywords
Partial onset seizures
Brief summary
The purpose of this study was to evaluate the safety and tolerability of perampanel (up to 12 mg/day) given as adjunctive treatment in subjects with refractory partial seizures and to evaluate the maintenance of effect of perampanel for the control of refractory partial seizures.
Detailed description
This was an open-label extension (OLE) study for subjects who completed one of the following double-blind, placebo-controlled, Phase 3 studies: E2007-G000-304 (NCT00699972), E2007-G000-305 (NCT00699582), and E2007-G000-306 (NCT00700310). This OLE study consisted of 2 phases: an Open-label Treatment Phase (comprised of a 16-week blinded Conversion Period and a 256-week Maintenance Period) and a Follow-up Phase (4 weeks). During the Conversion Period, subjects and investigators remained blinded to the treatment received in the previous DB study. To achieve this, all subjects continued to take 6 tablets of study medication (2 mg perampanel or matching placebo) or fewer as they were instructed during the core Double-Blind (DB) study. During the open-label Maintenance Period, subjects were treated with the perampanel dose that provided the best combination of individual efficacy and tolerability.
Interventions
DRUGperampanel
Perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study up to approximately 5 years
Sponsors
Eisai Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Each participant who met the following criteria were enrolled in this study: 1. Who completed Visit 8 of study E2007-G000-304, E2007-G000-305, or E2007-G000-306 and complied with the inclusion and
Exclusion criteria
for that study (excluding criteria that are related to seizure occurrences). 2. Provided written informed consent signed by participant or legal guardian prior to entering the study or undergoing any study procedures (If the written informed consent was provided by the legal guardian because the participant was unable to do so, a written or verbal assent from the participant was obtained). 3. Who was considered reliable and willing to be available for the study period and record seizures and report adverse events them self or have a caregiver who can record and report the events for them. 4. Females who were either of non-childbearing potential (defined as having undergone surgical sterilization, or postmenopausal \[\>age 50 and amenorrheic for 12 months\]) or of childbearing potential. Females of childbearing potential were enrolled only if they agreed to be abstinent or continue using at least 1 medically acceptable method of contraception (eg, a double-barrier method \[eg, condom + spermicide, condom + diaphragm with spermicide\], IUD, or have a vasectomised partner) throughout the study period and for 2 months after the last dose of study drug. Women using hormonal contraceptives were required to use an additional approved method of contraception (as described previously) continuously throughout the entire study period and for 2 months after the last dose of study drug. (It was not required for male subjects to use contraceptive measures based on preclinical toxicology data). 5. Continued to be treated with a stable dose of 1 or a maximum of 3 approved anti-epileptic drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, China, Czechia, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Philippines, Poland, Portugal, Romania, Russia, Serbia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
This was an open-label Extension (OLE) study for participants who completed one of the following double-blind (DB), placebo-controlled, Phase 3 studies: E2007-G000-304 (NCT00699972), E2007-G000-305(NCT00699582), and E2007-G000-306 (NCT00700310).
Pre-assignment details
From a total of 1218 participants who provided informed consent, 2 participants were lost to follow-up and did not have any postbaseline safety data after the first OLE dose.
Participants by arm
| Arm | Count |
|---|---|
| Perampanel Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years. | 1,218 |
| Total | 1,218 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative/Other | 502 |
| Overall Study | Adverse Event | 194 |
| Overall Study | Inadequate therapeutic effect | 202 |
| Overall Study | Lost to Follow-up | 33 |
| Overall Study | Participant choice | 252 |
Baseline characteristics
| Characteristic | Perampanel |
|---|---|
| Age, Continuous | 33 years |
| Sex: Female, Male Female | 607 Participants |
| Sex: Female, Male Male | 611 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1,018 / 1,216 |
| serious Total, serious adverse events | 288 / 1,216 |
Outcome results
Primary
Number of Participants With Treatment-emergent Non-Serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs)
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.
Time frame: From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years.
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Perampanel | Number of Participants With Treatment-emergent Non-Serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs) | Treatment-emergent non serious AEs | 1018 participants |
| Perampanel | Number of Participants With Treatment-emergent Non-Serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs) | Treatment-emergent SAEs | 288 participants |
Secondary
Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Perampanel | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 222-234, n = 37, 36, 11 | -81.36 Percent change |
| Perampanel | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 183-195, n = 210, 193, 89 | -66.63 Percent change |
| Perampanel | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 79-91, n = 762, 703, 329 | -53.06 Percent change |
| Perampanel | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 248-260, n = 5, 5, 1 | -97.16 Percent change |
| Perampanel | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 53-65, n = 882, 819, 381 | -49.34 Percent change |
| Perampanel | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 66-78, n = 822, 762, 357 | -51.65 Percent change |
| Perampanel | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 1-13 | -29.14 Percent change |
| Perampanel | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Wekks 27-39, n = 1088, 1011, 458 | -42.81 Percent change |
| Perampanel | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 14-26, n = 1159, 1073, 482 | -38.54 Percent change |
| Perampanel | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 170-182, n = 323, 297, 137 | -64.29 Percent change |
| Perampanel | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 157-169, n = 429, 396, 187 | -65.46 Percent change |
| Perampanel | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 235-247, n = 14, 13, 2 | -78.10 Percent change |
| Perampanel | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 144-156, n = 517, 478, 231 | -61.45 Percent change |
| Perampanel | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 118-130, n = 642, 590, 279 | -60.89 Percent change |
| Perampanel | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 131-143, n = 583, 535, 258 | -60.67 Percent change |
| Perampanel | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 196-208, n = 119, 111, 47 | -73.30 Percent change |
| Perampanel | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 40-52, n = 969, 903, 416 | -46.22 Percent change |
| Perampanel | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 105-117, n = 676, 624, 295 | -59.07 Percent change |
| Perampanel | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 209-221, n = 59, 57, 22 | -72.47 Percent change |
| Perampanel | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 92-104, n = 720, 664, 313 | -56.59 Percent change |
| Complex Partial Plus Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 1-13 | -32.42 Percent change |
| Complex Partial Plus Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 14-26, n = 1159, 1073, 482 | -43.19 Percent change |
| Complex Partial Plus Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 79-91, n = 762, 703, 329 | -55.38 Percent change |
| Complex Partial Plus Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 105-117, n = 676, 624, 295 | -63.62 Percent change |
| Complex Partial Plus Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 183-195, n = 210, 193, 89 | -74.78 Percent change |
| Complex Partial Plus Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 196-208, n = 119, 111, 47 | -80.77 Percent change |
| Complex Partial Plus Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 222-234, n = 37, 36, 11 | -89.02 Percent change |
| Complex Partial Plus Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 248-260, n = 5, 5, 1 | -98.39 Percent change |
| Complex Partial Plus Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Wekks 27-39, n = 1088, 1011, 458 | -46.22 Percent change |
| Complex Partial Plus Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 40-52, n = 969, 903, 416 | -49.39 Percent change |
| Complex Partial Plus Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 53-65, n = 882, 819, 381 | -54.95 Percent change |
| Complex Partial Plus Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 66-78, n = 822, 762, 357 | -56.25 Percent change |
| Complex Partial Plus Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 92-104, n = 720, 664, 313 | -62.11 Percent change |
| Complex Partial Plus Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 118-130, n = 642, 590, 279 | -66.75 Percent change |
| Complex Partial Plus Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 131-143, n = 583, 535, 258 | -65.46 Percent change |
| Complex Partial Plus Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 144-156, n = 517, 478, 231 | -67.95 Percent change |
| Complex Partial Plus Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 157-169, n = 429, 396, 187 | -72.21 Percent change |
| Complex Partial Plus Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 170-182, n = 323, 297, 137 | -76.37 Percent change |
| Complex Partial Plus Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 209-221, n = 59, 57, 22 | -80.69 Percent change |
| Complex Partial Plus Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 235-247, n = 14, 13, 2 | -100.0 Percent change |
| Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 40-52, n = 969, 903, 416 | -81.15 Percent change |
| Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 118-130, n = 642, 590, 279 | -100.00 Percent change |
| Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 183-195, n = 210, 193, 89 | -100.00 Percent change |
| Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 131-143, n = 583, 535, 258 | -99.70 Percent change |
| Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 105-117, n = 676, 624, 295 | -84.98 Percent change |
| Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Wekks 27-39, n = 1088, 1011, 458 | -77.47 Percent change |
| Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 144-156, n = 517, 478, 231 | -100.00 Percent change |
| Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 92-104, n = 720, 664, 313 | -90.33 Percent change |
| Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 14-26, n = 1159, 1073, 482 | -65.69 Percent change |
| Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 235-247, n = 14, 13, 2 | -100.00 Percent change |
| Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 157-169, n = 429, 396, 187 | -100.00 Percent change |
| Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 79-91, n = 762, 703, 329 | -90.68 Percent change |
| Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 53-65, n = 882, 819, 381 | -80.69 Percent change |
| Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 248-260, n = 5, 5, 1 | -98.39 Percent change |
| Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 1-13 | -54.95 Percent change |
| Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 66-78, n = 822, 762, 357 | -79.98 Percent change |
| Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 222-234, n = 37, 36, 11 | -99.11 Percent change |
| Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 209-221, n = 59, 57, 22 | -100.00 Percent change |
| Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 170-182, n = 323, 297, 137 | -100.00 Percent change |
| Secondarily Generalized Seizures | Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline. | Weeks 196-208, n = 119, 111, 47 | -100.00 Percent change |
Secondary
Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Perampanel | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 183-195, n = 210, 193, 89 | 62.9 Percent responders |
| Perampanel | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 157-169, n = 429, 396, 187 | 63.2 Percent responders |
| Perampanel | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 40-52, n = 969, 903, 416 | 45.6 Percent responders |
| Perampanel | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 209-221, n = 59, 57, 22 | 67.8 Percent responders |
| Perampanel | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 27-39, n = 1088, 1011, 458 | 44.2 Percent responders |
| Perampanel | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 53-65, n = 882, 819, 381 | 49.5 Percent responders |
| Perampanel | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 131-143, n = 583, 535, 258 | 59.3 Percent responders |
| Perampanel | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 14-26, n = 1159, 1073, 482 | 40.9 Percent responders |
| Perampanel | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 66-78, n = 822, 762, 357 | 51.5 Percent responders |
| Perampanel | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 222-234, n = 37, 36, 11 | 73.0 Percent responders |
| Perampanel | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 105-117, n = 676, 624, 295 | 57.1 Percent responders |
| Perampanel | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 79-91, n = 762, 703, 329 | 52.9 Percent responders |
| Perampanel | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 170-182, n = 323, 297, 137 | 60.1 Percent responders |
| Perampanel | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 235-247, n = 14, 13, 2 | 64.3 Percent responders |
| Perampanel | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 92-104, n = 720, 664, 313 | 57.2 Percent responders |
| Perampanel | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 248-260, n = 5, 5, 1 | 80.0 Percent responders |
| Perampanel | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 118-130, n = 642, 590, 279 | 58.9 Percent responders |
| Perampanel | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 196-208, n = 119, 111, 47 | 64.7 Percent responders |
| Perampanel | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 1-13 | 30.8 Percent responders |
| Perampanel | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 144-156, n = 517, 478, 231 | 60.9 Percent responders |
| Complex Partial Plus Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 14-26, n = 1159, 1073, 482 | 43.4 Percent responders |
| Complex Partial Plus Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 157-169, n = 429, 396, 187 | 65.7 Percent responders |
| Complex Partial Plus Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 170-182, n = 323, 297, 137 | 64.3 Percent responders |
| Complex Partial Plus Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 144-156, n = 517, 478, 231 | 62.6 Percent responders |
| Complex Partial Plus Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 183-195, n = 210, 193, 89 | 68.4 Percent responders |
| Complex Partial Plus Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 1-13 | 34.8 Percent responders |
| Complex Partial Plus Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 196-208, n = 119, 111, 47 | 71.2 Percent responders |
| Complex Partial Plus Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 209-221, n = 59, 57, 22 | 73.7 Percent responders |
| Complex Partial Plus Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 222-234, n = 37, 36, 11 | 75.0 Percent responders |
| Complex Partial Plus Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 248-260, n = 5, 5, 1 | 100.0 Percent responders |
| Complex Partial Plus Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 235-247, n = 14, 13, 2 | 69.2 Percent responders |
| Complex Partial Plus Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 27-39, n = 1088, 1011, 458 | 47.3 Percent responders |
| Complex Partial Plus Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 40-52, n = 969, 903, 416 | 49.4 Percent responders |
| Complex Partial Plus Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 53-65, n = 882, 819, 381 | 53.2 Percent responders |
| Complex Partial Plus Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 66-78, n = 822, 762, 357 | 54.9 Percent responders |
| Complex Partial Plus Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 79-91, n = 762, 703, 329 | 55.6 Percent responders |
| Complex Partial Plus Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 105-117, n = 676, 624, 295 | 59.5 Percent responders |
| Complex Partial Plus Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 92-104, n = 720, 664, 313 | 58.6 Percent responders |
| Complex Partial Plus Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 118-130, n = 642, 590, 279 | 61.9 Percent responders |
| Complex Partial Plus Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 131-143, n = 583, 535, 258 | 61.5 Percent responders |
| Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 248-260, n = 5, 5, 1 | 100.0 Percent responders |
| Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 1-13 | 54.5 Percent responders |
| Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 14-26, n = 1159, 1073, 482 | 58.7 Percent responders |
| Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 27-39, n = 1088, 1011, 458 | 63.3 Percent responders |
| Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 118-130, n = 642, 590, 279 | 71.3 Percent responders |
| Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 144-156, n = 517, 478, 231 | 74.0 Percent responders |
| Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 40-52, n = 969, 903, 416 | 67.8 Percent responders |
| Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 53-65, n = 882, 819, 381 | 65.6 Percent responders |
| Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 66-78, n = 822, 762, 357 | 66.1 Percent responders |
| Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 79-91, n = 762, 703, 329 | 66.0 Percent responders |
| Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 92-104, n = 720, 664, 313 | 69.3 Percent responders |
| Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 105-117, n = 676, 624, 295 | 68.1 Percent responders |
| Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 131-143, n = 583, 535, 258 | 71.3 Percent responders |
| Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 157-169, n = 429, 396, 187 | 76.5 Percent responders |
| Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 170-182, n = 323, 297, 137 | 78.8 Percent responders |
| Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 183-195, n = 210, 193, 89 | 80.9 Percent responders |
| Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 196-208, n = 119, 111, 47 | 85.1 Percent responders |
| Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 209-221, n = 59, 57, 22 | 77.3 Percent responders |
| Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 222-234, n = 37, 36, 11 | 72.7 Percent responders |
| Secondarily Generalized Seizures | Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline. | Weeks 235-247, n = 14, 13, 2 | 100.0 Percent responders |