Refractory Partial Seizures
Conditions
Keywords
Seizure, epilepsy
Brief summary
The purpose of this trial is to investigate the safety and tolerability of perampanel in long- term treatment in the patients with refractory partial epilepsy (uncontrolled with other anti-epileptic drugs) who completed Week 10 of Phase II Study E2007-J081-231 study.
Interventions
DRUGperampanel
Patients will receive the same oral dosage (2 mg up to 12 mg once daily before bedtime) as used in the maintenance period of Study 231.
Sponsors
Eisai Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who consent to the study entry on their free will before starting any trial-related activities. 2. Patients who participated in Study 231 and completed the required evaluation period (10 weeks). 3. Patients who are certainly and voluntarily able to participate in this study and record their seizures by themselves or have family members or caregivers (or nurses, if hospitalized) record the seizures. Patients who wish to continue perampanel treatment and necessitate receiving the long- term administration judged by the investigator or sub-investigator.
Exclusion criteria
1. Pregnant or lactating women, women of child-bearing potential, women willing to become pregnant. 2. Patients who are ineligible judged by the investigator or sub investigator in light of medical history or complication at enrollment in treatment period. 3. Patients who operate heavy equipment or drive should not be recruited into the study. 4. Patients who are ineligible for study entry judged by the investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel | From date of first dose up to 30 days after the last dose of study treatment, up to approximately 7 years 2 months | Safety was assessed by monitoring adverse events (AEs), adverse drug reactions, clinical laboratory parameters, vital signs, 12-lead electrocardiogram, and dependency questionnaire. AEs were graded on a 3-point scale; 1) mild: (Grade 1) discomfort noticed, but no disruption of normal daily activity, 2) moderate: (Grade 2) discomfort reduced or affected normal daily activity, and 3) severe: (Grade 3) incapacitating, with inability to work or to perform normal daily activity. AE severity associated with abnormal changes in laboratory parameters was assessed using the Ministry of Health and Welfare Notification Number 80 Classification of Severity of Adverse Drug Reactions of Medicinal Products. TEAEs were defined as AEs that emerged during treatment (absent at pretreatment \[Baseline\]), reemerged during treatment (were present at pretreatment but stopped before treatment), or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | From Week 1 through Week 316 and Follow-up Period of the Extension Study, up to approximately 7 years 2 months | Seizure frequency was derived from information (seizure count and type) recorded in the participant diary. The seizure frequency per 28 days was calculated as the number of seizures over the time interval multiplied by 28 and divided by the number of days in the interval. The percent change in 28-day seizure frequency from baseline was assessed for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures. Of the 21 participants, 20 participants concomitantly used at least 1 inducer anti-epileptic drug (AED) (carbamazepine, phenytoin, phenobarbital, or primidone), and 1 participant used only non-inducer AEDs. The data is presented as median percent change with full range. |
| Responder Rate During the Treatment Period-LOCF | Week 1 through Week 316 and Follow-up period of the Extension study, up to approximately 7 years 2 months | Responder rate (percentage of participants with greater than or equal to 50% reduction in seizure frequency for 28 days in the Treatment Period relative to that for 28 days in the observation period of Study 231 \[responder\]. If the reduction in seizure frequency is less than 50%, then the participants are considered as non-responders. LOCF = Last Observation Carried Forward. |
| The Patient Global Impression of Change (PGIC) at Week 52 and End of Treatment | Week 52 and End of Treatment; up to approximately 7 years 2 months | Each participant evaluated him/herself for PGIC at Week 52 of the Treatment Period and at the end of treatment (or discontinuation) by comparing seizure conditions during 4 weeks before Week 52 of the Treatment Period and those during 4 weeks before end of treatment (or discontinuation) of the open label extension study with those during 4 weeks before start of the Treatment Period of Study 231. Assessment was implemented based on frequency of seizure, severity of seizures, AEs, and overall conditions using the 7-grade scores. The evaluation used a 7-point scale with the scores 1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse. |
| The Clinical Global Impression of Change (CGIC) at Week 52 and End of Treatment | Week 52 and End of Treatment, up to approximately 7 years 2 months | The investigator evaluated each participant for CGIC at Week 52 of the Treatment Period and at the end of treatment (or discontinuation) by comparing medical conditions during 4 weeks before Week 52 of the Treatment Period and those during 4 weeks before end of treatment (or discontinuation) of the open label extension study with those during 4 weeks before start of the Treatment Period of Study 231. Assessment was implemented based on frequency of seizure, severity of seizures, AEs, and overall conditions using the 7-grade scores. The evaluation used a 7-point scale with the scores 1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Perampanel Participants were treated with the perampanel dose that was administered in maintenance period of Study E2007-J081-231 (Study 231) \[NCT00849212\]. In some instances, a 1-step down-titration from the viewpoint of safety and up-titration to the maintenance dose of Study 231 was allowed. In general, 1 to 6 tablets of perampanel was administered orally as a 2-milligram (mg) tablet (2 mg to 12 mg) once daily before bedtime (under fed conditions as much as possible).
The investigator, or subinvestigator, was allowed to complete the treatment by tapering the study drug after end of treatment or discontinuation (Follow-up Period), as appropriate. The taper period was 4 weeks at the longest. | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 5 |
| Overall Study | Physician Decision | 6 |
| Overall Study | Reason other than lack of efficacy | 4 |
Baseline characteristics
| Characteristic | Perampanel |
|---|---|
| Age, Continuous | 36.5 Years STANDARD_DEVIATION 11.02 |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 21 / 21 |
| serious Total, serious adverse events | 5 / 21 |
Outcome results
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel
Safety was assessed by monitoring adverse events (AEs), adverse drug reactions, clinical laboratory parameters, vital signs, 12-lead electrocardiogram, and dependency questionnaire. AEs were graded on a 3-point scale; 1) mild: (Grade 1) discomfort noticed, but no disruption of normal daily activity, 2) moderate: (Grade 2) discomfort reduced or affected normal daily activity, and 3) severe: (Grade 3) incapacitating, with inability to work or to perform normal daily activity. AE severity associated with abnormal changes in laboratory parameters was assessed using the Ministry of Health and Welfare Notification Number 80 Classification of Severity of Adverse Drug Reactions of Medicinal Products. TEAEs were defined as AEs that emerged during treatment (absent at pretreatment \[Baseline\]), reemerged during treatment (were present at pretreatment but stopped before treatment), or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous.
Time frame: From date of first dose up to 30 days after the last dose of study treatment, up to approximately 7 years 2 months
Population: The Safety Analysis Set (SAS) was defined as all participants who met the inclusion/exclusion criteria regarding indication (inclusion criteria number 5 of Study 231), who received at least one dose of study treatment, and who had at least one evaluable set of safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Perampanel | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel | TEAEs | 21 Participants |
| Perampanel | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel | Treatment-related TEAEs | 11 Participants |
| Perampanel | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel | TEAEs Leading to Study Treatment Dose Reduction | 2 Participants |
| Perampanel | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel | Serious TEAEs | 5 Participants |
Secondary
Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316
Seizure frequency was derived from information (seizure count and type) recorded in the participant diary. The seizure frequency per 28 days was calculated as the number of seizures over the time interval multiplied by 28 and divided by the number of days in the interval. The percent change in 28-day seizure frequency from baseline was assessed for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures. Of the 21 participants, 20 participants concomitantly used at least 1 inducer anti-epileptic drug (AED) (carbamazepine, phenytoin, phenobarbital, or primidone), and 1 participant used only non-inducer AEDs. The data is presented as median percent change with full range.
Time frame: From Week 1 through Week 316 and Follow-up Period of the Extension Study, up to approximately 7 years 2 months
Population: The Efficacy Analysis Population (identical to the SAS for this study) was defined as all participants who met the inclusion/exclusion criteria regarding indication (inclusion criteria number 5 of Study 231), who received at least one dose of study treatment, and who had at least one data on efficacy.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Perampanel | Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | Weeks 9 to 16 | -26.32 Percent change in seizure frequency |
| Perampanel | Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | Weeks 17 to 28 | -36.67 Percent change in seizure frequency |
| Perampanel | Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | Weeks 29 to 40 | -31.10 Percent change in seizure frequency |
| Perampanel | Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | Weeks 41 to 52 | -49.36 Percent change in seizure frequency |
| Perampanel | Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | Weeks 65 to 76 | -36.09 Percent change in seizure frequency |
| Perampanel | Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | Weeks 77 to 88 | -38.82 Percent change in seizure frequency |
| Perampanel | Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | Weeks 113 to 124 | -57.49 Percent change in seizure frequency |
| Perampanel | Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | Weeks 173 to 184 | -34.52 Percent change in seizure frequency |
| Perampanel | Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | Weeks 185 to 196 | -34.12 Percent change in seizure frequency |
| Perampanel | Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | Weeks 197 to 208 | -83.53 Percent change in seizure frequency |
| Perampanel | Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | Weeks 1 to 4 | -33.33 Percent change in seizure frequency |
| Perampanel | Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | Weeks 5 to 8 | -36.36 Percent change in seizure frequency |
| Perampanel | Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | Weeks 53 to 64 | -42.43 Percent change in seizure frequency |
| Perampanel | Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | Weeks 89 to 100 | -57.65 Percent change in seizure frequency |
| Perampanel | Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | Weeks 101 to 112 | -52.45 Percent change in seizure frequency |
| Perampanel | Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | Weeks 125 to 136 | -36.27 Percent change in seizure frequency |
| Perampanel | Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | Weeks 137 to 148 | -41.81 Percent change in seizure frequency |
| Perampanel | Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | Weeks 149 to 160 | -41.13 Percent change in seizure frequency |
| Perampanel | Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | Weeks 161 to 172 | -39.76 Percent change in seizure frequency |
| Perampanel | Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | Weeks 209 to 220 | -58.97 Percent change in seizure frequency |
| Perampanel | Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | Weeks 221 to 232 | -41.83 Percent change in seizure frequency |
| Perampanel | Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | Weeks 233 to 244 | -75.29 Percent change in seizure frequency |
| Perampanel | Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | Weeks 245 to 256 | -83.53 Percent change in seizure frequency |
| Perampanel | Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | Weeks 257 to 268 | -83.53 Percent change in seizure frequency |
| Perampanel | Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | Weeks 269 to 280 | -95.88 Percent change in seizure frequency |
| Perampanel | Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | Weeks 281 to 292 | -83.35 Percent change in seizure frequency |
| Perampanel | Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | Weeks 293 to 304 | -87.65 Percent change in seizure frequency |
| Perampanel | Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | Weeks 305 to 316 | -99.59 Percent change in seizure frequency |
| Perampanel | Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 | Follow-up period | -8.40 Percent change in seizure frequency |
Secondary
Responder Rate During the Treatment Period-LOCF
Responder rate (percentage of participants with greater than or equal to 50% reduction in seizure frequency for 28 days in the Treatment Period relative to that for 28 days in the observation period of Study 231 \[responder\]. If the reduction in seizure frequency is less than 50%, then the participants are considered as non-responders. LOCF = Last Observation Carried Forward.
Time frame: Week 1 through Week 316 and Follow-up period of the Extension study, up to approximately 7 years 2 months
Population: Efficacy Analysis Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 9 to 16; Responder | 28.6 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 9 to 16; Non-Responder | 71.4 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 17 to 28; Responder | 40.0 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 17 to 28; Non-Responder | 60.0 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 29 to 40; Responder | 44.4 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 29 to 40; Non-Responder | 55.6 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 41 to 52; Responder | 47.1 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 41 to 52; Non-Responder | 52.9 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 53 to 64; Responder | 41.2 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 53 to 64; Non-Responder | 58.8 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 65 to 76; Responder | 41.2 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 65 to 76; Non-Responder | 58.8 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 77 to 88; Responder | 31.3 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 77 to 88; Non-Responder | 68.8 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 89 to 100; Responder | 56.3 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 89 to 100; Non-Responder | 43.8 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 101 to 112; Responder | 50.0 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 101 to 112; Non-Responder | 50.0 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 113 to 124; Responder | 56.3 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 113 to 124; Non-Responder | 43.8 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 125 to 136; Responder | 40.0 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 125 to 136; Non-Responder | 60.0 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 137 to 148; Responder | 38.5 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 137 to 148; Non-Responder | 61.5 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 149 to 160; Responder | 50.0 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 149 to 160; Non- Responder | 50.0 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 161 to 172; Responder | 40.0 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 161 to 172; Non-Responder | 60.0 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 173 to 184; Responder | 40.0 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 173 to 184; Non-Responder | 60.0 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 185 to 196; Responder | 44.4 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 185 to 196; Non-Responder | 55.6 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 197 to 208; Responder | 66.7 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 197 to 208; Non-Responder | 33.3 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 221 to 232; Responder | 44.4 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 221 to 232; Non-Responder | 55.6 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 233 to 244; Responder | 57.1 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 233 to 244; Non-Responder | 42.9 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 245 to 256; Responder | 85.7 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 245 to 256; Non-Responder | 14.3 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 257 to 268; Responder | 85.7 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 257 to 268; Non-Responder | 14.3 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 269 to 280; Responder | 83.3 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 269-280; Non-Responder | 16.7 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 281 to 292; Responder | 83.3 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 281 to 292; Non-Responder | 16.7 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 293 to 304; Responder | 83.3 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 293 to 304; Non-Responder | 16.7 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 305 to 316; Responder | 100.0 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 305 to 316; Non-Responder | 0.0 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Follow-up period; Responder | 20.0 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Follow-up period; Non-responder | 80.0 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 1 to 4; Responder | 42.9 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 1 to 4; Non-Responder | 57.1 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 5 to 9; Responder | 42.9 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 5 to 9; Non-Responder | 57.1 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 209 to 220; Responder | 55.6 Percentage of participants |
| Perampanel | Responder Rate During the Treatment Period-LOCF | Weeks 209 to 220; Non-Responder | 44.4 Percentage of participants |
Secondary
The Clinical Global Impression of Change (CGIC) at Week 52 and End of Treatment
The investigator evaluated each participant for CGIC at Week 52 of the Treatment Period and at the end of treatment (or discontinuation) by comparing medical conditions during 4 weeks before Week 52 of the Treatment Period and those during 4 weeks before end of treatment (or discontinuation) of the open label extension study with those during 4 weeks before start of the Treatment Period of Study 231. Assessment was implemented based on frequency of seizure, severity of seizures, AEs, and overall conditions using the 7-grade scores. The evaluation used a 7-point scale with the scores 1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse.
Time frame: Week 52 and End of Treatment, up to approximately 7 years 2 months
Population: Efficacy Analysis Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Perampanel | The Clinical Global Impression of Change (CGIC) at Week 52 and End of Treatment | Very much improved; Week 52 | 11.8 Percentage of participants |
| Perampanel | The Clinical Global Impression of Change (CGIC) at Week 52 and End of Treatment | Much improved; Week 52 | 5.9 Percentage of participants |
| Perampanel | The Clinical Global Impression of Change (CGIC) at Week 52 and End of Treatment | Minimally improved; Week 52 | 64.7 Percentage of participants |
| Perampanel | The Clinical Global Impression of Change (CGIC) at Week 52 and End of Treatment | Much worse; Week 52 | 0.0 Percentage of participants |
| Perampanel | The Clinical Global Impression of Change (CGIC) at Week 52 and End of Treatment | Very much worse; Week 52 | 0.0 Percentage of participants |
| Perampanel | The Clinical Global Impression of Change (CGIC) at Week 52 and End of Treatment | Minimally improved; End of Treatment | 19.0 Percentage of participants |
| Perampanel | The Clinical Global Impression of Change (CGIC) at Week 52 and End of Treatment | No change; End of Treatment | 61.9 Percentage of participants |
| Perampanel | The Clinical Global Impression of Change (CGIC) at Week 52 and End of Treatment | No change; Week 52 | 17.6 Percentage of participants |
| Perampanel | The Clinical Global Impression of Change (CGIC) at Week 52 and End of Treatment | Minimally worse; Week 52 | 0.0 Percentage of participants |
| Perampanel | The Clinical Global Impression of Change (CGIC) at Week 52 and End of Treatment | Very much improved; End of Treatment | 9.5 Percentage of participants |
| Perampanel | The Clinical Global Impression of Change (CGIC) at Week 52 and End of Treatment | Much improved; End of Treatment | 9.5 Percentage of participants |
| Perampanel | The Clinical Global Impression of Change (CGIC) at Week 52 and End of Treatment | Minimally worse; End of Treatment | 0.0 Percentage of participants |
| Perampanel | The Clinical Global Impression of Change (CGIC) at Week 52 and End of Treatment | Much worse; End of Treatment | 0.0 Percentage of participants |
| Perampanel | The Clinical Global Impression of Change (CGIC) at Week 52 and End of Treatment | Very much worse; End of Treatment | 0.0 Percentage of participants |
Secondary
The Patient Global Impression of Change (PGIC) at Week 52 and End of Treatment
Each participant evaluated him/herself for PGIC at Week 52 of the Treatment Period and at the end of treatment (or discontinuation) by comparing seizure conditions during 4 weeks before Week 52 of the Treatment Period and those during 4 weeks before end of treatment (or discontinuation) of the open label extension study with those during 4 weeks before start of the Treatment Period of Study 231. Assessment was implemented based on frequency of seizure, severity of seizures, AEs, and overall conditions using the 7-grade scores. The evaluation used a 7-point scale with the scores 1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse.
Time frame: Week 52 and End of Treatment; up to approximately 7 years 2 months
Population: Efficacy Analysis Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Perampanel | The Patient Global Impression of Change (PGIC) at Week 52 and End of Treatment | Very much improved; Week 52 | 17.6 Percentage of participants |
| Perampanel | The Patient Global Impression of Change (PGIC) at Week 52 and End of Treatment | Much improved; Week 52 | 17.6 Percentage of participants |
| Perampanel | The Patient Global Impression of Change (PGIC) at Week 52 and End of Treatment | No change; Week 52 | 11.8 Percentage of participants |
| Perampanel | The Patient Global Impression of Change (PGIC) at Week 52 and End of Treatment | Much worse; Week 52 | 0.0 Percentage of participants |
| Perampanel | The Patient Global Impression of Change (PGIC) at Week 52 and End of Treatment | Minimally worse; End of Treatment | 4.8 Percentage of participants |
| Perampanel | The Patient Global Impression of Change (PGIC) at Week 52 and End of Treatment | Much worse; End of Treatment | 0.0 Percentage of participants |
| Perampanel | The Patient Global Impression of Change (PGIC) at Week 52 and End of Treatment | Very much worse; End of Treatment | 0.0 Percentage of participants |
| Perampanel | The Patient Global Impression of Change (PGIC) at Week 52 and End of Treatment | Minimally improved; Week 52 | 52.9 Percentage of participants |
| Perampanel | The Patient Global Impression of Change (PGIC) at Week 52 and End of Treatment | Minimally worse; Week 52 | 0.0 Percentage of participants |
| Perampanel | The Patient Global Impression of Change (PGIC) at Week 52 and End of Treatment | Very much worse; Week 52 | 0.0 Percentage of participants |
| Perampanel | The Patient Global Impression of Change (PGIC) at Week 52 and End of Treatment | Very much improved; End of Treatment | 14.3 Percentage of participants |
| Perampanel | The Patient Global Impression of Change (PGIC) at Week 52 and End of Treatment | Much improved; End of Treatment | 14.3 Percentage of participants |
| Perampanel | The Patient Global Impression of Change (PGIC) at Week 52 and End of Treatment | Minimally improved; End of Treatment | 28.6 Percentage of participants |
| Perampanel | The Patient Global Impression of Change (PGIC) at Week 52 and End of Treatment | No change; End of Treatment | 38.1 Percentage of participants |