Central Nervous System
Conditions
Brief summary
This study is designed to evaluate the pharmacokinetics, efficacy, and safety of perampanel oral suspension on seizure frequency in pediatric participants maintained on one to three stable antiepileptic drugs
Detailed description
This is a multicenter, multiple ascending dose, open-label study (Core Study) with an Extension Phase. The Core Study consisted of 2 phases, the Pretreatment Phase and the Treatment Phase. The Pretreatment Phase lasted up to 2 weeks in duration, during which participants were assessed for their eligibility to participate in the study. The Treatment Phase consisted of 3 periods: Titration (7 weeks), Maintenance (4 weeks), and Follow-up (4 weeks; only for those participants not rolling over into the Extension Phase after completing the Treatment Phase and for those participants who discontinued from the study). All subjects who completed all scheduled visits up to and including the final visit of the Treatment Phase (Core Study) were eligible to participate in the Extension Phase of the study. The Extension Phase consisted of 2 periods: Maintenance (41 weeks) and Follow-up (4 weeks).
Interventions
DRUGperampanel
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
Sponsors
Eisai Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
Inclusion: 1. Have a minimum weight of 10 kg (22 lb) 2. Have had brain imaging (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) prior to Visit 1 that ruled out a progressive cause of epilepsy 3. Have a diagnosis of epilepsy with any type of seizure according to the International League Against Epilepsy's (ILAE) Classification of Epileptic Seizures (1981). Diagnosis should have been established at least 6 months prior to Visit 1, by clinical history and an electroencephalogram (EEG) that is consistent with epilepsy; normal interictal EEGs will be allowed provided that the participant meets the other diagnosis criterion (i.e. clinical history) 4. Have had one or more seizure(s) during the 4 weeks prior to Visit 1 5. Are currently being treated with stable doses of one to a maximum of three AEDs for at least 4 weeks prior to Visit 1 and throughout the study duration (Only one perampanel inducing AED \[i.e. carbamazepine, oxcarbazepine, phenytoin\] out of the maximum of 3 AEDs is allowed in at least one third of the participants in each age cohort and not to exceed one half of the population of each age cohort. The remaining participants should not be taking any inducer) 6. Have been on their current concomitant AED regimen for 2 months or more with a stable dose for at least 4 weeks prior to Visit 1 7. Must have discontinued all restricted medications at least 2 weeks or five half-lives (whichever is longer) prior to Visit 1 8. Females aged at least 8 years or of child-bearing potential must have a negative serum beta-hCG at Visit 1 and a negative urine pregnancy test prior to titration at Visit 2. Female participants of childbearing potential must agree for the duration of the study and for a period of at least 60 days following administration of the last dose of study drug to be abstinent or commit to the consistent and correct use of a medically acceptable method of birth control (e.g., a double-barrier method \[condom + spermicide, condom + diaphragm with spermicide\]) Exclusion: 1. Have a history of status epilepticus that required hospitalization during the 6 months prior to Visit 1 2. Have current or a history of pseudo-seizures (psychogenic non-epileptic seizures \[PNES\]) from birth or within approximately 5 years prior to Visit 1 3. Have seizures due to treatable medical conditions, such as those arising due to metabolic disturbances, toxic exposure, or an active infection 4. Have epilepsy secondary to progressive cerebral disease or any other progressive neurodegenerative disease 5. Have had epilepsy surgery within 1 year prior to Visit 1 6. Are scheduled and/or confirmed to have epilepsy surgery within 6 months after Visit 1; however, those who have previously documented failed epilepsy surgery will be allowed 7. Use of intermittent rescue benzodiazepines (i.e. 1-2 doses over a 24-hour period considered one-time rescue) two or more times in a 30-day period prior to Visit 1 8. If felbamate is used as a concomitant AED, participants must be on felbamate for at least 2 years, with a stable dose for 8 weeks prior to Visit 1. They must not have a history of white blood cell (WBC) count below 2500/L (2.50 x 10\^9/L), platelets below 100,000, liver function tests (LFTs) above 3 times the upper limit of normal (ULN), or other indication of hepatic or bone marrow dysfunction while receiving felbamate. If participants received felbamate in the past, it must have been discontinued 8 weeks prior to Visit 1 9. Have concomitant use of vigabatrin: participants who took vigabatrin in the past must be off vigabatrin for approximately 5 months prior to Visit 1 and must have documentation showing no evidence of a vigabatrin-associated clinically significant abnormality in the visual perimetry test 10. If ketogenic diet is used, participants must be on a stable regimen for at least 4 weeks prior to Visit 1 11. Have previously participated in a clinical trial involving perampanel
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apparent Clearance (CL/F) of Perampanel [Core Study] | From Day 8 up to Day 78 | CL/F was defined as the volume of plasma cleared of the drug per unit time. Blood samples were collected at day 8, Day 36, Day 64 , and Day 78. The CL/F values were calculated for each visit and averaged to derive the total CL/F value per arm. Data was analyzed for 2 categories: CYP3A4/5 inducers (carbamazepine, oxcarbazepine and phenytoin) and non-inducers. Data is presented as mean Liter per hour +/-standard deviation. |
| Steady-state Average Concentration (C av,ss) of Perampanel [Core Study] | From Day 8 up to Day 78 | C av,ss was calculated as 'Dose (mg)/Dosing Interval (24 h)/(CL/F \[L/h\]) x 1000'. C av,ss during a dosing interval was dose-normalized to 0.12 mg/kg in participants aged ≥ 2 to less than 12 years (intended to correspond to 8 mg/70 kg in adults/adolescents). Blood samples were collected at day 8, Day 36, Day 64 , and Day 78. C av,ss values were calculated for each visit and averaged to derive the total C av,ss value per arm. Data was analysed for 2 categories: CYP3A4/5 inducers (carbamazepine, oxcarbazepine and phenytoin) and non-inducers. Data is presented as mean Liter per hour +/- standard deviation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Non-Serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel | For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase | An AE was defined as any untoward medical occurrence in a participant administered with the study drug. 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/non-serious) that started/increased in severity on/after the first dose of study drug up to 30 days after the final dose of study drug) were assessed. The details of the adverse events are presented in the safety section of the results. |
| Palatability Questionnaire Assessment - Based on Its Taste, Smell, and How it Felt in the Mouth, How Easy or Difficult Was it for You / Your Child to Take This Medicine Every Day [Core Study] | Week 5 or at the time of early discontinuation | The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the five options (very easy, easy, neither easy or difficult, difficult and very difficult). |
| Palatability Questionnaire Assessment - Would You/Your Child Have Preferred This Medicine to Have Been Flavored, e.g. Fruity [Core Study] | Week 5 or at the time of early discontinuation | The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the three options (yes, no and don't mind). |
| Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Weeks 1-13, Weeks 14-26, Weeks 27-39, and Weeks 40-52 | Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated 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. The data is presented as mean percent change +/- standard deviation. |
| 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Weeks 1-13, Weeks 14-26, Weeks 27-39, and Weeks 40-52 | Responder rate was defined as the proportion of participants with a 50% decrease in 28-day seizure frequency during the overall treatment duration. The percentage of responders was assessed from Week 1 of perampanel treatment through successive 13-week intervals for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures with baseline as Pretreatment Phase (Visit 1) of 2 weeks plus 4 weeks Prior to Pretreatment Phase. The data is presented as percentage of responders. |
| Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Weeks 1-13, Weeks 14-26, Weeks 27-39, and Weeks 40-52 | Seizure-free rate, defined as the percentage of participants who were seizure-free during the Maintenance Period. The percentage of participants who were seizure free was assessed from Week 1 of perampanel treatment through successive 13-week intervals for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures with baseline as Pretreatment Phase (Visit 1) of 2 weeks plus 4 weeks Prior to Pretreatment Phase. The data is presented as the percentage of participants. |
| The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 0 (Baseline), Week 11, Week 28, Week 52 or EOT | The Clinical Global Impression (CGI) evaluated perceived seizure frequency and severity, the occurrence of AEs, and overall functional status of the participant. The investigator performed the Clinical Global Impression of Severity for all participants at Baseline (Week 0). The evaluation used a 7-point scale where 1=normal, not at all ill and 7=extremely ill. The investigator performed the Clinical Global Impression of Change for all participants at planned visit and at EOT (the duration after the day of first study drug dose up to 7 days after the Extension Phase drug dose, inclusive). The evaluation used a 7-point scale where 1=very much improved and 7=very much worse. This tool was used to assess the participant's status over the 4-week period prior to the planned/EOT visits compared to Baseline (Week 0). |
| Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study] | Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Week 0 to Week 15 | Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated 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. The data is presented as mean percent change +/- standard deviation. |
| 50% Responder Rate During the Maintenance Period-LOCF [Core Study] | Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Week 9 to 11 | Responder rate was defined as the proportion of participants with a 50% decrease in 28-day seizure frequency during the Maintenance Period compared to Baseline \[2 weeks Pretreatment Phase (Visit 1) plus 4 Weeks Prior to Pretreatment Phase\] for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures. The data is presented as percent responders. LOCF = Last Observation Carried Forward. |
| Seizure-free Rate During the Maintenance Period [Core Study] | Week 9 to Week 11 | Seizure-free rate, defined as the percentage of participants who were seizure-free during the Maintenance Period. SG = Secondary Generalization. |
| The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | Week 0 (Baseline), Week 11 or EOT | The Clinical Global Impression (CGI) evaluated perceived seizure frequency and severity, the occurrence of AEs, and overall functional status of the participant. The investigator performed the Clinical Global Impression of Severity for all participants at Baseline (Week 0). The evaluation used a 7-point scale where 1=normal, not at all ill and 7=extremely ill. The investigator performed the Clinical Global Impression of Change for all participants at the EOT (the duration after the day of first study drug dose up to 7 days after the last Core Phase drug dose, inclusive). The evaluation used a 7-point scale where 1=very much improved and 7=very much worse. This tool was used to assess the participant's status over the 4-week period prior to its completion compared to Baseline (Week 0). |
| Palatability Questionnaire Assessment - How Does This Medicine Taste [Core Study] | Week 5 or at the time of early discontinuation | The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the five options (very good, good, not good-not bad, bad, very bad). |
| Palatability Questionnaire Assessment - How Does This Medicine Smell [Core Study] | Week 5 or at the time of early discontinuation | The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the five options (very good, good, not good-not bad, bad, very bad). |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Effect of the Most Common Concomitant AEDs on Population PK Parameters: AUC | 11 weeks | This outcome was not assessed in the study. |
| The Effect of the Most Common Concomitant AEDs on Population PK Parameters: Cmax | 11 weeks | This outcome was not assessed in the study. |
| The Effect of the Most Common Concomitant AEDs on Population PK Parameters: Tmax | 11 weeks | This outcome was not assessed in the study. |
| The Effect of Demographics on Population PK Parameters: Cmax | 11 weeks | This outcome was not assessed in the study. |
| The Effect of Demographics on Population PK Parameters: AUC | 11 weeks | This outcome was not assessed in the study. |
| The Effect of Demographics on Population PK Parameters: Tmax | 11 weeks | This outcome was not assessed in the study. |
Countries
United States
Participant flow
Pre-assignment details
Of the 63 participants who were enrolled, 13 participants were screen failures and 50 participants were eligible to continue in the Core Study. Of the 42 subjects who completed the Core Study, 41 subjects continued into the Extension Phase.
Participants by arm
| Arm | Count |
|---|---|
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. | 22 |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. | 28 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Core Study | Adverse Event | 0 | 2 |
| Core Study | Inadequate Therapeutic Effect | 1 | 0 |
| Core Study | Lost to Follow-up | 0 | 1 |
| Core Study | Other | 0 | 2 |
| Core Study | Subject Choice | 1 | 0 |
| Core Study | Withdrawal by Subject | 0 | 1 |
| Extension Phase | Adverse Event | 4 | 2 |
| Extension Phase | Inadequate therapeutic effect | 1 | 1 |
| Extension Phase | Lost to Follow-up | 0 | 1 |
| Extension Phase | Other | 0 | 3 |
| Extension Phase | Subject Choice | 1 | 1 |
Baseline characteristics
| Characteristic | Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Total |
|---|---|---|---|
| Age, Continuous | 5 Years | 9 Years | 7.5 Years |
| Sex: Female, Male Female | 7 Participants | 9 Participants | 16 Participants |
| Sex: Female, Male Male | 15 Participants | 19 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 22 / 22 | 25 / 28 | 19 / 19 | 22 / 22 |
| serious Total, serious adverse events | 3 / 22 | 5 / 28 | 6 / 19 | 7 / 22 |
Outcome results
Primary
Apparent Clearance (CL/F) of Perampanel [Core Study]
CL/F was defined as the volume of plasma cleared of the drug per unit time. Blood samples were collected at day 8, Day 36, Day 64 , and Day 78. The CL/F values were calculated for each visit and averaged to derive the total CL/F value per arm. Data was analyzed for 2 categories: CYP3A4/5 inducers (carbamazepine, oxcarbazepine and phenytoin) and non-inducers. Data is presented as mean Liter per hour +/-standard deviation.
Time frame: From Day 8 up to Day 78
Population: The pharmacokinetic (PK) analysis set, defined as participants with at least 1 pharmacokinetic assessment of perampanel with a documented dosing history.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Apparent Clearance (CL/F) of Perampanel [Core Study] | Non-Inducers (N=14, 12) | 0.732 Liter per hour | Standard Deviation 0.374 |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Apparent Clearance (CL/F) of Perampanel [Core Study] | Inducers (N=6, 10) | 1.73 Liter per hour | Standard Deviation 1.18 |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Apparent Clearance (CL/F) of Perampanel [Core Study] | Non-Inducers (N=14, 12) | 0.956 Liter per hour | Standard Deviation 0.4 |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Apparent Clearance (CL/F) of Perampanel [Core Study] | Inducers (N=6, 10) | 1.92 Liter per hour | Standard Deviation 0.517 |
Primary
Steady-state Average Concentration (C av,ss) of Perampanel [Core Study]
C av,ss was calculated as 'Dose (mg)/Dosing Interval (24 h)/(CL/F \[L/h\]) x 1000'. C av,ss during a dosing interval was dose-normalized to 0.12 mg/kg in participants aged ≥ 2 to less than 12 years (intended to correspond to 8 mg/70 kg in adults/adolescents). Blood samples were collected at day 8, Day 36, Day 64 , and Day 78. C av,ss values were calculated for each visit and averaged to derive the total C av,ss value per arm. Data was analysed for 2 categories: CYP3A4/5 inducers (carbamazepine, oxcarbazepine and phenytoin) and non-inducers. Data is presented as mean Liter per hour +/- standard deviation.
Time frame: From Day 8 up to Day 78
Population: The PK analysis set, defined as participants with at least 1 pharmacokinetic assessment of perampanel with a documented dosing history.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Steady-state Average Concentration (C av,ss) of Perampanel [Core Study] | Non-Inducers (N=14, 12) | 179 ng/mL | Standard Deviation 110 |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Steady-state Average Concentration (C av,ss) of Perampanel [Core Study] | Inducers (N=6, 10) | 96.8 ng/mL | Standard Deviation 90.4 |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Steady-state Average Concentration (C av,ss) of Perampanel [Core Study] | Non-Inducers (N=14, 12) | 266 ng/mL | Standard Deviation 220 |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Steady-state Average Concentration (C av,ss) of Perampanel [Core Study] | Inducers (N=6, 10) | 105 ng/mL | Standard Deviation 38.9 |
Secondary
50% Responder Rate During the Maintenance Period-LOCF [Core Study]
Responder rate was defined as the proportion of participants with a 50% decrease in 28-day seizure frequency during the Maintenance Period compared to Baseline \[2 weeks Pretreatment Phase (Visit 1) plus 4 Weeks Prior to Pretreatment Phase\] for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures. The data is presented as percent responders. LOCF = Last Observation Carried Forward.
Time frame: Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Week 9 to 11
Population: The full analysis set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | 50% Responder Rate During the Maintenance Period-LOCF [Core Study] | Overall seizures | 72.7 Percent responders |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | 50% Responder Rate During the Maintenance Period-LOCF [Core Study] | Overall partial seizures | 82.4 Percent responders |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | 50% Responder Rate During the Maintenance Period-LOCF [Core Study] | Overall generalized seizures | 76.9 Percent responders |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | 50% Responder Rate During the Maintenance Period-LOCF [Core Study] | Unclassified Seizures | 66.7 Percent responders |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | 50% Responder Rate During the Maintenance Period-LOCF [Core Study] | Unclassified Seizures | 100 Percent responders |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | 50% Responder Rate During the Maintenance Period-LOCF [Core Study] | Overall seizures | 53.8 Percent responders |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | 50% Responder Rate During the Maintenance Period-LOCF [Core Study] | Overall generalized seizures | 33.3 Percent responders |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | 50% Responder Rate During the Maintenance Period-LOCF [Core Study] | Overall partial seizures | 60.9 Percent responders |
Secondary
50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Responder rate was defined as the proportion of participants with a 50% decrease in 28-day seizure frequency during the overall treatment duration. The percentage of responders was assessed from Week 1 of perampanel treatment through successive 13-week intervals for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures with baseline as Pretreatment Phase (Visit 1) of 2 weeks plus 4 weeks Prior to Pretreatment Phase. The data is presented as percentage of responders.
Time frame: Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Weeks 1-13, Weeks 14-26, Weeks 27-39, and Weeks 40-52
Population: The Full Analysis Set included all subjects who took at least 1 dose of perampanel during the Extension Phase, and had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to Pretreatment Phase (Visit 1) of the Core Study and had any seizure frequency data during the Extension Phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Generalized Seizures- Weeks 1-13; N=11, 6 | 72.7 Percentage of responders |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Partial Seizures- Weeks 1-13; N=14,19 | 64.3 Percentage of responders |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Generalized Seizures- Weeks 14-26; N=11, 6 | 81.8 Percentage of responders |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Seizures- Weeks 27-39; N=18, 20 | 77.8 Percentage of responders |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Generalized Seizures- Weeks 27-39; N=10, 6 | 70.0 Percentage of responders |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Partial Seizures- Weeks 14-26; N=14, 19 | 85.7 Percentage of responders |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Generalized Seizures- Weeks 40-52; N=7, 3 | 71.4 Percentage of responders |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Seizures- Weeks 14-26 | 84.2 Percentage of responders |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Unclassified Epileptic Seizure- Weeks 1-13; N=2, 1 | 100.0 Percentage of responders |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Partial Seizures- Weeks 27-39; N=14, 17 | 92.9 Percentage of responders |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Unclassified Epileptic Seizure- Weeks 14-26; N=2,1 | 100.0 Percentage of responders |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Seizures- Weeks 40-52; N=15, 15 | 80.0 Percentage of responders |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Unclassified Epileptic Seizure- Weeks 27-39; N=2,1 | 50.0 Percentage of responders |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Partial Seizures- Weeks 40-52; N=14, 14 | 71.4 Percentage of responders |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Unclassified Epileptic Seizure- Weeks 40-52; N=2,1 | 100.0 Percentage of responders |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Seizures- Weeks 1-13 | 57.9 Percentage of responders |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Unclassified Epileptic Seizure- Weeks 40-52; N=2,1 | 100.0 Percentage of responders |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Seizures- Weeks 14-26 | 45.5 Percentage of responders |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Seizures- Weeks 27-39; N=18, 20 | 45.0 Percentage of responders |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Seizures- Weeks 40-52; N=15, 15 | 46.7 Percentage of responders |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Partial Seizures- Weeks 1-13; N=14,19 | 57.9 Percentage of responders |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Partial Seizures- Weeks 14-26; N=14, 19 | 57.9 Percentage of responders |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Partial Seizures- Weeks 27-39; N=14, 17 | 52.9 Percentage of responders |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Partial Seizures- Weeks 40-52; N=14, 14 | 42.9 Percentage of responders |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Generalized Seizures- Weeks 1-13; N=11, 6 | 16.7 Percentage of responders |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Generalized Seizures- Weeks 14-26; N=11, 6 | 33.3 Percentage of responders |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Generalized Seizures- Weeks 27-39; N=10, 6 | 16.7 Percentage of responders |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Generalized Seizures- Weeks 40-52; N=7, 3 | 33.3 Percentage of responders |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Unclassified Epileptic Seizure- Weeks 1-13; N=2, 1 | 0.0 Percentage of responders |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Unclassified Epileptic Seizure- Weeks 14-26; N=2,1 | 0.0 Percentage of responders |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Unclassified Epileptic Seizure- Weeks 27-39; N=2,1 | 0.0 Percentage of responders |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Seizures- Weeks 1-13 | 45.5 Percentage of responders |
Secondary
Number of Participants With Treatment Emergent Non-Serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel
An AE was defined as any untoward medical occurrence in a participant administered with the study drug. 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/non-serious) that started/increased in severity on/after the first dose of study drug up to 30 days after the final dose of study drug) were assessed. The details of the adverse events are presented in the safety section of the results.
Time frame: For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Population: The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Number of Participants With Treatment Emergent Non-Serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel | Treatment Emergent Non-Serious AEs | 22 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Number of Participants With Treatment Emergent Non-Serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel | Treatment Emergent SAEs | 3 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Number of Participants With Treatment Emergent Non-Serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel | Treatment Emergent SAEs | 5 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Number of Participants With Treatment Emergent Non-Serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel | Treatment Emergent Non-Serious AEs | 25 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase | Number of Participants With Treatment Emergent Non-Serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel | Treatment Emergent Non-Serious AEs | 19 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase | Number of Participants With Treatment Emergent Non-Serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel | Treatment Emergent SAEs | 6 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase | Number of Participants With Treatment Emergent Non-Serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel | Treatment Emergent Non-Serious AEs | 22 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase | Number of Participants With Treatment Emergent Non-Serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel | Treatment Emergent SAEs | 7 Participants |
Secondary
Palatability Questionnaire Assessment - Based on Its Taste, Smell, and How it Felt in the Mouth, How Easy or Difficult Was it for You / Your Child to Take This Medicine Every Day [Core Study]
The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the five options (very easy, easy, neither easy or difficult, difficult and very difficult).
Time frame: Week 5 or at the time of early discontinuation
Population: The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Palatability Questionnaire Assessment - Based on Its Taste, Smell, and How it Felt in the Mouth, How Easy or Difficult Was it for You / Your Child to Take This Medicine Every Day [Core Study] | Easy | 5 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Palatability Questionnaire Assessment - Based on Its Taste, Smell, and How it Felt in the Mouth, How Easy or Difficult Was it for You / Your Child to Take This Medicine Every Day [Core Study] | Difficult | 0 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Palatability Questionnaire Assessment - Based on Its Taste, Smell, and How it Felt in the Mouth, How Easy or Difficult Was it for You / Your Child to Take This Medicine Every Day [Core Study] | Neither easy or difficult | 3 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Palatability Questionnaire Assessment - Based on Its Taste, Smell, and How it Felt in the Mouth, How Easy or Difficult Was it for You / Your Child to Take This Medicine Every Day [Core Study] | Very Difficult | 0 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Palatability Questionnaire Assessment - Based on Its Taste, Smell, and How it Felt in the Mouth, How Easy or Difficult Was it for You / Your Child to Take This Medicine Every Day [Core Study] | Very easy | 6 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Palatability Questionnaire Assessment - Based on Its Taste, Smell, and How it Felt in the Mouth, How Easy or Difficult Was it for You / Your Child to Take This Medicine Every Day [Core Study] | Very Difficult | 1 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Palatability Questionnaire Assessment - Based on Its Taste, Smell, and How it Felt in the Mouth, How Easy or Difficult Was it for You / Your Child to Take This Medicine Every Day [Core Study] | Very easy | 7 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Palatability Questionnaire Assessment - Based on Its Taste, Smell, and How it Felt in the Mouth, How Easy or Difficult Was it for You / Your Child to Take This Medicine Every Day [Core Study] | Easy | 7 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Palatability Questionnaire Assessment - Based on Its Taste, Smell, and How it Felt in the Mouth, How Easy or Difficult Was it for You / Your Child to Take This Medicine Every Day [Core Study] | Neither easy or difficult | 3 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Palatability Questionnaire Assessment - Based on Its Taste, Smell, and How it Felt in the Mouth, How Easy or Difficult Was it for You / Your Child to Take This Medicine Every Day [Core Study] | Difficult | 1 Participants |
Secondary
Palatability Questionnaire Assessment - How Does This Medicine Smell [Core Study]
The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the five options (very good, good, not good-not bad, bad, very bad).
Time frame: Week 5 or at the time of early discontinuation
Population: The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Palatability Questionnaire Assessment - How Does This Medicine Smell [Core Study] | Good | 5 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Palatability Questionnaire Assessment - How Does This Medicine Smell [Core Study] | Bad | 1 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Palatability Questionnaire Assessment - How Does This Medicine Smell [Core Study] | Very good | 0 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Palatability Questionnaire Assessment - How Does This Medicine Smell [Core Study] | Very bad | 0 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Palatability Questionnaire Assessment - How Does This Medicine Smell [Core Study] | Not good, not bad | 7 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Palatability Questionnaire Assessment - How Does This Medicine Smell [Core Study] | Very bad | 1 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Palatability Questionnaire Assessment - How Does This Medicine Smell [Core Study] | Good | 3 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Palatability Questionnaire Assessment - How Does This Medicine Smell [Core Study] | Not good, not bad | 13 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Palatability Questionnaire Assessment - How Does This Medicine Smell [Core Study] | Bad | 0 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Palatability Questionnaire Assessment - How Does This Medicine Smell [Core Study] | Very good | 2 Participants |
Secondary
Palatability Questionnaire Assessment - How Does This Medicine Taste [Core Study]
The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the five options (very good, good, not good-not bad, bad, very bad).
Time frame: Week 5 or at the time of early discontinuation
Population: The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Palatability Questionnaire Assessment - How Does This Medicine Taste [Core Study] | Good | 6 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Palatability Questionnaire Assessment - How Does This Medicine Taste [Core Study] | Bad | 2 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Palatability Questionnaire Assessment - How Does This Medicine Taste [Core Study] | Not good, not bad | 2 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Palatability Questionnaire Assessment - How Does This Medicine Taste [Core Study] | Very bad | 0 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Palatability Questionnaire Assessment - How Does This Medicine Taste [Core Study] | Very good | 3 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Palatability Questionnaire Assessment - How Does This Medicine Taste [Core Study] | Very bad | 3 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Palatability Questionnaire Assessment - How Does This Medicine Taste [Core Study] | Very good | 3 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Palatability Questionnaire Assessment - How Does This Medicine Taste [Core Study] | Good | 7 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Palatability Questionnaire Assessment - How Does This Medicine Taste [Core Study] | Not good, not bad | 3 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Palatability Questionnaire Assessment - How Does This Medicine Taste [Core Study] | Bad | 3 Participants |
Secondary
Palatability Questionnaire Assessment - Would You/Your Child Have Preferred This Medicine to Have Been Flavored, e.g. Fruity [Core Study]
The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the three options (yes, no and don't mind).
Time frame: Week 5 or at the time of early discontinuation
Population: The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Palatability Questionnaire Assessment - Would You/Your Child Have Preferred This Medicine to Have Been Flavored, e.g. Fruity [Core Study] | Yes | 4 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Palatability Questionnaire Assessment - Would You/Your Child Have Preferred This Medicine to Have Been Flavored, e.g. Fruity [Core Study] | No | 2 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Palatability Questionnaire Assessment - Would You/Your Child Have Preferred This Medicine to Have Been Flavored, e.g. Fruity [Core Study] | Don't mind | 9 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Palatability Questionnaire Assessment - Would You/Your Child Have Preferred This Medicine to Have Been Flavored, e.g. Fruity [Core Study] | Don't mind | 5 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Palatability Questionnaire Assessment - Would You/Your Child Have Preferred This Medicine to Have Been Flavored, e.g. Fruity [Core Study] | Yes | 9 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Palatability Questionnaire Assessment - Would You/Your Child Have Preferred This Medicine to Have Been Flavored, e.g. Fruity [Core Study] | No | 5 Participants |
Secondary
Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated 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. The data is presented as mean percent change +/- standard deviation.
Time frame: Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Weeks 1-13, Weeks 14-26, Weeks 27-39, and Weeks 40-52
Population: The Full Analysis Set included all subjects who took at least 1 dose of perampanel during the Extension Phase, and had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to Pretreatment Phase (Visit 1) of the Core Study and had any seizure frequency data during the Extension Phase.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Seizures- Weeks 1-13 | -58.74 Percent change |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Seizures- Weeks 14-26 | -76.89 Percent change |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Seizures- Weeks 27-39; N=18, 20 | -80.93 Percent change |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Seizures- Weeks 40-52; N=15, 15 | -77.58 Percent change |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Partial Seizures- Weeks 1-13; N=14,19 | -79.62 Percent change |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Partial Seizures- Weeks 14-26; N=14, 19 | -78.69 Percent change |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Partial Seizures- Weeks 27-39; N=14, 17 | -89.49 Percent change |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Partial Seizures- Weeks 40-52; N=14, 14 | -89.89 Percent change |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Generalized Seizures- Weeks 1-13; N=11, 6 | -63.96 Percent change |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Generalized Seizures- Weeks 14-26; N=11, 6 | -79.08 Percent change |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Generalized Seizures- Weeks 27-39; N=10, 6 | -73.93 Percent change |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Generalized Seizures- Weeks 40-52; N=7, 3 | -76.91 Percent change |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Unclassified Epileptic Seizure- Weeks 1-13; N=2, 1 | -88.74 Percent change |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Unclassified Epileptic Seizure- Weeks 14-26; N=2,1 | -100.0 Percent change |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Unclassified Epileptic Seizure- Weeks 27-39; N=2,1 | -58.24 Percent change |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Unclassified Epileptic Seizure- Weeks 40-52; N=2,1 | -100.0 Percent change |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Unclassified Epileptic Seizure- Weeks 40-52; N=2,1 | -73.21 Percent change |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Seizures- Weeks 1-13 | -39.59 Percent change |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Generalized Seizures- Weeks 1-13; N=11, 6 | 177.58 Percent change |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Seizures- Weeks 14-26 | -39.19 Percent change |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Unclassified Epileptic Seizure- Weeks 1-13; N=2, 1 | -41.61 Percent change |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Seizures- Weeks 27-39; N=18, 20 | -45.60 Percent change |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Generalized Seizures- Weeks 14-26; N=11, 6 | -14.13 Percent change |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Seizures- Weeks 40-52; N=15, 15 | -47.25 Percent change |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Unclassified Epileptic Seizure- Weeks 27-39; N=2,1 | 6.81 Percent change |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Partial Seizures- Weeks 1-13; N=14,19 | -56.04 Percent change |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Generalized Seizures- Weeks 27-39; N=10, 6 | -4.77 Percent change |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Partial Seizures- Weeks 14-26; N=14, 19 | -67.30 Percent change |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Unclassified Epileptic Seizure- Weeks 14-26; N=2,1 | -21.07 Percent change |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Partial Seizures- Weeks 27-39; N=14, 17 | -53.57 Percent change |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Generalized Seizures- Weeks 40-52; N=7, 3 | -5.86 Percent change |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Overall Partial Seizures- Weeks 40-52; N=14, 14 | -39.46 Percent change |
Secondary
Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study]
Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated 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. The data is presented as mean percent change +/- standard deviation.
Time frame: Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Week 0 to Week 15
Population: The full analysis set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study] | Overall seizures | -43.6 Percent change |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study] | Overall partial seizures | -82.5 Percent change |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study] | Overall generalized seizures | -53.1 Percent change |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study] | Unclassified Seizures | -73.7 Percent change |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study] | Unclassified Seizures | -67.3 Percent change |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study] | Overall seizures | -33.9 Percent change |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study] | Overall generalized seizures | 305.4 Percent change |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study] | Overall partial seizures | -46.8 Percent change |
Secondary
Seizure-free Rate During the Maintenance Period [Core Study]
Seizure-free rate, defined as the percentage of participants who were seizure-free during the Maintenance Period. SG = Secondary Generalization.
Time frame: Week 9 to Week 11
Population: The full analysis set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Maintenance Period [Core Study] | Complex Partial | 80 Percentage of participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Maintenance Period [Core Study] | Myoclonic Generalized | 80 Percentage of participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Maintenance Period [Core Study] | Overall Seizures | 15 Percentage of participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Maintenance Period [Core Study] | Clonic Generalized | 100 Percentage of participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Maintenance Period [Core Study] | Partial Seizures with SG | 75 Percentage of participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Maintenance Period [Core Study] | Tonic Generalized | 85 Percentage of participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Maintenance Period [Core Study] | Simple Partial with Motor signs | 80 Percentage of participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Maintenance Period [Core Study] | Tonic Clonic Generalized | 80 Percentage of participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Maintenance Period [Core Study] | Overall Partial Seizures | 50 Percentage of participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Maintenance Period [Core Study] | Atonic Generalized | 95 Percentage of participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Maintenance Period [Core Study] | Simple Partial without Motor Signs | 100 Percentage of participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Maintenance Period [Core Study] | Absence Generalized | 95 Percentage of participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Maintenance Period [Core Study] | Unclassified Seizures | 100 Percentage of participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Maintenance Period [Core Study] | Overall Generalized seizures | 55 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Maintenance Period [Core Study] | Unclassified Seizures | 95.5 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Maintenance Period [Core Study] | Overall Seizures | 27.3 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Maintenance Period [Core Study] | Simple Partial without Motor Signs | 100 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Maintenance Period [Core Study] | Simple Partial with Motor signs | 95.5 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Maintenance Period [Core Study] | Complex Partial | 50 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Maintenance Period [Core Study] | Partial Seizures with SG | 90.9 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Maintenance Period [Core Study] | Overall Partial Seizures | 45.5 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Maintenance Period [Core Study] | Absence Generalized | 90.9 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Maintenance Period [Core Study] | Myoclonic Generalized | 86.4 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Maintenance Period [Core Study] | Clonic Generalized | 100 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Maintenance Period [Core Study] | Tonic Generalized | 90.9 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Maintenance Period [Core Study] | Tonic Clonic Generalized | 90.9 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Maintenance Period [Core Study] | Atonic Generalized | 95.5 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Maintenance Period [Core Study] | Overall Generalized seizures | 77.3 Percentage of participants |
Secondary
Seizure-free Rate During the Overall Treatment Duration [Extension Phase]
Seizure-free rate, defined as the percentage of participants who were seizure-free during the Maintenance Period. The percentage of participants who were seizure free was assessed from Week 1 of perampanel treatment through successive 13-week intervals for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures with baseline as Pretreatment Phase (Visit 1) of 2 weeks plus 4 weeks Prior to Pretreatment Phase. The data is presented as the percentage of participants.
Time frame: Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Weeks 1-13, Weeks 14-26, Weeks 27-39, and Weeks 40-52
Population: The Full Analysis Set included all subjects who took at least 1 dose of perampanel during the Extension Phase, and had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to Pretreatment Phase (Visit 1) of the Core Study and had any seizure frequency data during the Extension Phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Overall Seizures- Weeks 1-13 | 21.1 Percentage of participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Overall Seizures- Weeks 14-26;N=18, 20 | 22.2 Percentage of participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Overall Seizures- Weeks 27-39; N=15, 15 | 13.3 Percentage of participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Overall Seizures- Weeks 40-52; N=11, 11 | 27.3 Percentage of participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Overall Partial Seizures- Weeks 1-13 | 52.6 Percentage of participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Overall Partial Seizures- Weeks 14-26; N=18, 20 | 55.6 Percentage of participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Overall Partial Seizures- Weeks 27-39; N=15, 15 | 33.3 Percentage of participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Overall Partial Seizures- Weeks 40-52; N=11, 11 | 36.4 Percentage of participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Overall Generalized Seizures- Weeks 1-13 | 57.9 Percentage of participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Overall Generalized Seizures- Weeks 14-26; N=18,20 | 55.6 Percentage of participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Overall Generalized Seizures- Weeks 27-39; N=15,15 | 66.7 Percentage of participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Overall Generalized Seizures- Weeks 40-52; N=11,11 | 63.6 Percentage of participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Unclassified Epileptic Seizure- Weeks 1-13 | 100.0 Percentage of participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Unclassified Epileptic Seizure-Weeks 14-26;N=18,20 | 100.0 Percentage of participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Unclassified Epileptic Seizure-Weeks 27-39;N=15,15 | 93.3 Percentage of participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Unclassified Epileptic Seizure-Weeks 40-52;N=11,11 | 100.0 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Unclassified Epileptic Seizure-Weeks 40-52;N=11,11 | 90.9 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Overall Seizures- Weeks 1-13 | 22.7 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Overall Generalized Seizures- Weeks 1-13 | 72.7 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Overall Seizures- Weeks 14-26;N=18, 20 | 30.0 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Unclassified Epileptic Seizure- Weeks 1-13 | 90.9 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Overall Seizures- Weeks 27-39; N=15, 15 | 33.3 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Overall Generalized Seizures- Weeks 14-26; N=18,20 | 75.0 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Overall Seizures- Weeks 40-52; N=11, 11 | 36.4 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Unclassified Epileptic Seizure-Weeks 27-39;N=15,15 | 93.3 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Overall Partial Seizures- Weeks 1-13 | 40.9 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Overall Generalized Seizures- Weeks 27-39; N=15,15 | 80.0 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Overall Partial Seizures- Weeks 14-26; N=18, 20 | 45.0 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Unclassified Epileptic Seizure-Weeks 14-26;N=18,20 | 95.0 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Overall Partial Seizures- Weeks 27-39; N=15, 15 | 40.0 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Overall Generalized Seizures- Weeks 40-52; N=11,11 | 90.9 Percentage of participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Overall Partial Seizures- Weeks 40-52; N=11, 11 | 45.5 Percentage of participants |
Secondary
The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study]
The Clinical Global Impression (CGI) evaluated perceived seizure frequency and severity, the occurrence of AEs, and overall functional status of the participant. The investigator performed the Clinical Global Impression of Severity for all participants at Baseline (Week 0). The evaluation used a 7-point scale where 1=normal, not at all ill and 7=extremely ill. The investigator performed the Clinical Global Impression of Change for all participants at the EOT (the duration after the day of first study drug dose up to 7 days after the last Core Phase drug dose, inclusive). The evaluation used a 7-point scale where 1=very much improved and 7=very much worse. This tool was used to assess the participant's status over the 4-week period prior to its completion compared to Baseline (Week 0).
Time frame: Week 0 (Baseline), Week 11 or EOT
Population: The Full Analysis Set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | Baseline - Moderately ill (N=22,27) | 10 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | EOT - Very much improved (N=22, 25) | 6 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | Baseline - Normal, not at all ill (N=22, 27) | 6 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | EOT - Much improved (N=22, 25) | 8 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | Baseline - Markedly ill (N=22, 27) | 3 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | EOT - Minimally improved (N=22, 25) | 5 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | Baseline - Mildly ill (N=22, 27) | 3 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | EOT - No Change (N=22, 25) | 2 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | Baseline - Severely ill (N=22, 27) | 0 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | EOT - Minimally worse (N=22, 25) | 0 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | Baseline - Borderline mentally ill (N=22, 27) | 0 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | Baseline - Extremely ill (N=22, 27) | 0 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | EOT - Very much worse (N=22, 25) | 1 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | EOT - Much worse (N=22, 25) | 0 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | EOT - Very much worse (N=22, 25) | 0 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | Baseline - Normal, not at all ill (N=22, 27) | 5 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | Baseline - Borderline mentally ill (N=22, 27) | 0 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | Baseline - Mildly ill (N=22, 27) | 4 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | Baseline - Moderately ill (N=22,27) | 11 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | Baseline - Markedly ill (N=22, 27) | 4 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | Baseline - Severely ill (N=22, 27) | 3 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | Baseline - Extremely ill (N=22, 27) | 0 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | EOT - Very much improved (N=22, 25) | 7 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | EOT - Much improved (N=22, 25) | 8 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | EOT - Minimally improved (N=22, 25) | 5 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | EOT - No Change (N=22, 25) | 3 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | EOT - Minimally worse (N=22, 25) | 1 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | EOT - Much worse (N=22, 25) | 1 Participants |
Secondary
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
The Clinical Global Impression (CGI) evaluated perceived seizure frequency and severity, the occurrence of AEs, and overall functional status of the participant. The investigator performed the Clinical Global Impression of Severity for all participants at Baseline (Week 0). The evaluation used a 7-point scale where 1=normal, not at all ill and 7=extremely ill. The investigator performed the Clinical Global Impression of Change for all participants at planned visit and at EOT (the duration after the day of first study drug dose up to 7 days after the Extension Phase drug dose, inclusive). The evaluation used a 7-point scale where 1=very much improved and 7=very much worse. This tool was used to assess the participant's status over the 4-week period prior to the planned/EOT visits compared to Baseline (Week 0).
Time frame: Week 0 (Baseline), Week 11, Week 28, Week 52 or EOT
Population: The Full Analysis Set included all subjects who took at least 1 dose of perampanel during the Extension Phase, and had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to Pretreatment Phase (Visit 1) of the Core Study and had any seizure frequency data during the Extension Phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 11- Minimally improved; N=19, 21 | 3 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 28- Minimally worse; N=18, 19 | 0 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Baseline- Severely ill | 0 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 28- Much worse; N=18, 19 | 0 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 11- No change; N= 19, 21 | 2 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 28- Very much worse; N=18, 19 | 0 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Baseline- Moderately ill | 10 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 52- Very much improved; N=14, 12 | 1 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 11- Minimally worse; N=19, 21 | 0 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 52- Much improved; N=14, 12 | 7 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Baseline- Extremely ill | 0 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 52- Minimally worse; N=14, 12 | 0 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 52- Minimally improved; N=14, 12 | 4 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 11- Much worse; N=19, 21 | 0 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 52- No change; N=14, 12 | 1 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Baseline- Mildly ill | 3 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 11- Very much worse; N=19, 21 | 0 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 52- Much worse; N=14, 12 | 1 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 11- Very much improved; N=19, 21 | 6 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 52- Very much worse; N=14, 12 | 0 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 28- Very much improved; N=18, 19 | 5 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | EOT- Very much improved | 1 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Baseline- Markedly ill | 1 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | EOT- Much improved | 8 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 28- Much improved; N=18, 19 | 7 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | EOT- Minimally improved | 5 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 11- Much improved; N=19, 21 | 8 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | EOT- No change | 4 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 28- Minimally improved; N=18, 19 | 2 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | EOT- Minimally worse | 0 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Baseline- Borderline mentally ill | 0 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | EOT- Much worse | 1 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 28- No change; N=18, 19 | 4 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | EOT- Very much worse | 0 Participants |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Baseline- Normal, not at all ill | 5 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | EOT- Very much worse | 0 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Baseline- Normal, not at all ill | 3 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Baseline- Borderline mentally ill | 0 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Baseline- Mildly ill | 4 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Baseline- Moderately ill | 10 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Baseline- Markedly ill | 4 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Baseline- Severely ill | 1 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Baseline- Extremely ill | 0 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 11- Very much improved; N=19, 21 | 7 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 11- Much improved; N=19, 21 | 7 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 11- Minimally improved; N=19, 21 | 5 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 11- No change; N= 19, 21 | 2 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 11- Minimally worse; N=19, 21 | 0 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 11- Much worse; N=19, 21 | 0 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 11- Very much worse; N=19, 21 | 0 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 28- Very much improved; N=18, 19 | 4 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 28- Much improved; N=18, 19 | 8 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 28- Minimally improved; N=18, 19 | 3 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 28- No change; N=18, 19 | 3 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 28- Minimally worse; N=18, 19 | 1 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 28- Much worse; N=18, 19 | 0 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 28- Very much worse; N=18, 19 | 0 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 52- Very much improved; N=14, 12 | 3 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 52- Much improved; N=14, 12 | 5 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 52- Minimally improved; N=14, 12 | 4 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 52- No change; N=14, 12 | 0 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 52- Minimally worse; N=14, 12 | 0 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 52- Much worse; N=14, 12 | 0 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | Week 52- Very much worse; N=14, 12 | 0 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | EOT- Very much improved | 4 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | EOT- Much improved | 9 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | EOT- Minimally improved | 6 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | EOT- No change | 2 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | EOT- Minimally worse | 1 Participants |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase] | EOT- Much worse | 0 Participants |
Other Pre-specified
The Effect of Demographics on Population PK Parameters: AUC
This outcome was not assessed in the study.
Time frame: 11 weeks
Population: This outcome was not assessed in the study.
Other Pre-specified
The Effect of Demographics on Population PK Parameters: Cmax
This outcome was not assessed in the study.
Time frame: 11 weeks
Population: This outcome was not assessed in the study.
Other Pre-specified
The Effect of Demographics on Population PK Parameters: Tmax
This outcome was not assessed in the study.
Time frame: 11 weeks
Population: This outcome was not assessed in the study.
Other Pre-specified
The Effect of the Most Common Concomitant AEDs on Population PK Parameters: AUC
This outcome was not assessed in the study.
Time frame: 11 weeks
Population: This outcome was not assessed in the study.
Other Pre-specified
The Effect of the Most Common Concomitant AEDs on Population PK Parameters: Cmax
This outcome was not assessed in the study.
Time frame: 11 weeks
Population: This outcome was not assessed in the study.
Other Pre-specified
The Effect of the Most Common Concomitant AEDs on Population PK Parameters: Tmax
This outcome was not assessed in the study.
Time frame: 11 weeks
Population: This outcome was not assessed in the study.