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Pharmacokinetics, Efficacy, and Safety of Perampanel Oral Suspension on Seizure Frequency in Pediatric Subjects Maintained on One to Three Stable Antiepileptic Drugs

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ClinicalTrials.gov Identifier: NCT01527006
Recruitment Status : Completed
First Posted : February 6, 2012
Results First Posted : August 28, 2015
Last Update Posted : July 12, 2016
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Central Nervous System
Intervention Drug: perampanel
Enrollment 63
Recruitment Details  
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.
Arm/Group Title Cohort ( ≥ 2 to < 7 Years of Age) Cohort ( ≥ 7 to < 12 Years of Age)
Hide Arm/Group Description 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. 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.
Period Title: Core Study
Started 22 28
Completed 20 22
Not Completed 2 6
Reason Not Completed
Adverse Event             0             2
Lost to Follow-up             0             1
Subject Choice             1             0
Inadequate Therapeutic Effect             1             0
Withdrawal by Subject             0             1
Not Specified             0             2
Period Title: Extension Phase
Started 19 [1] 22
Completed 13 14
Not Completed 6 8
Reason Not Completed
Adverse Event             4             2
Lost to Follow-up             0             1
Subject Choice             1             1
Inadequate therapeutic effect             1             1
Not Specified             0             3
[1]
Of the 20 subjects who completed the Core Study, 19 subjects continued into the Extension Phase.
Arm/Group Title Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study Total
Hide Arm/Group Description 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 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. Total of all reporting groups
Overall Number of Baseline Participants 22 28 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 22 participants 28 participants 50 participants
5
(2 to 6)
9
(7 to 11)
7.5
(2 to 11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 28 participants 50 participants
Female
7
  31.8%
9
  32.1%
16
  32.0%
Male
15
  68.2%
19
  67.9%
34
  68.0%
1.Primary Outcome
Title Apparent Clearance (CL/F) of Perampanel [Core Study]
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) analysis set, defined as participants with at least 1 pharmacokinetic assessment of perampanel with a documented dosing history.
Arm/Group Title Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 20 22
Mean (Standard Deviation)
Unit of Measure: Liter per hour
Non-Inducers (N=14, 12) 0.732  (0.374) 0.956  (0.4)
Inducers (N=6, 10) 1.73  (1.18) 1.92  (0.517)
2.Primary Outcome
Title Steady-state Average Concentration (C av,ss) of Perampanel [Core Study]
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set, defined as participants with at least 1 pharmacokinetic assessment of perampanel with a documented dosing history.
Arm/Group Title Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 20 22
Mean (Standard Deviation)
Unit of Measure: ng/mL
Non-Inducers (N=14, 12) 179  (110) 266  (220)
Inducers (N=6, 10) 96.8  (90.4) 105  (38.9)
3.Secondary Outcome
Title Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study]
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 22 28
Median (Full Range)
Unit of Measure: Percent change
Overall seizures
-43.6
(-100 to 95.4)
-33.9
(-100 to 1038.9)
Overall partial seizures
-82.5
(-100 to 95.4)
-46.8
(-100 to 1722.2)
Overall generalized seizures
-53.1
(-100 to 188.7)
305.4
(-62.9 to 1277.3)
Unclassified Seizures
-73.7
(-100 to 217.3)
-67.3
(-100 to -34.6)
4.Secondary Outcome
Title 50% Responder Rate During the Maintenance Period-LOCF [Core Study]
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 22 28
Measure Type: Number
Unit of Measure: Percent responders
Overall seizures 72.7 53.8
Overall partial seizures 82.4 60.9
Overall generalized seizures 76.9 33.3
Unclassified Seizures 66.7 100
5.Secondary Outcome
Title Seizure-free Rate During the Maintenance Period [Core Study]
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 20 22
Measure Type: Number
Unit of Measure: Percentage of participants
Overall Seizures 15 27.3
Simple Partial without Motor Signs 100 100
Simple Partial with Motor signs 80 95.5
Complex Partial 80 50
Partial Seizures with SG 75 90.9
Overall Partial Seizures 50 45.5
Absence Generalized 95 90.9
Myoclonic Generalized 80 86.4
Clonic Generalized 100 100
Tonic Generalized 85 90.9
Tonic Clonic Generalized 80 90.9
Atonic Generalized 95 95.5
Overall Generalized seizures 55 77.3
Unclassified Seizures 100 95.5
6.Secondary Outcome
Title The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study]
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 22 27
Measure Type: Number
Unit of Measure: Participants
Baseline - Normal, not at all ill (N=22, 27) 6 5
Baseline - Borderline mentally ill (N=22, 27) 0 0
Baseline - Mildly ill (N=22, 27) 3 4
Baseline - Moderately ill (N=22,27) 10 11
Baseline - Markedly ill (N=22, 27) 3 4
Baseline - Severely ill (N=22, 27) 0 3
Baseline - Extremely ill (N=22, 27) 0 0
EOT - Very much improved (N=22, 25) 6 7
EOT - Much improved (N=22, 25) 8 8
EOT - Minimally improved (N=22, 25) 5 5
EOT - No Change (N=22, 25) 2 3
EOT - Minimally worse (N=22, 25) 0 1
EOT - Much worse (N=22, 25) 0 1
EOT - Very much worse (N=22, 25) 1 0
7.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 22 28 19 22
Measure Type: Number
Unit of Measure: Participants
Treatment Emergent Non-Serious AEs 22 25 19 22
Treatment Emergent SAEs 3 5 6 7
8.Secondary Outcome
Title Palatability Questionnaire Assessment - How Does This Medicine Taste [Core Study]
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment.
Arm/Group Title Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 13 19
Measure Type: Number
Unit of Measure: Participants
Very good 3 3
Good 6 7
Not good, not bad 2 3
Bad 2 3
Very bad 0 3
9.Secondary Outcome
Title Palatability Questionnaire Assessment - How Does This Medicine Smell [Core Study]
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment.
Arm/Group Title Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 13 19
Measure Type: Number
Unit of Measure: Participants
Very good 0 2
Good 5 3
Not good, not bad 7 13
Bad 1 0
Very bad 0 1
10.Secondary Outcome
Title 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]
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment.
Arm/Group Title Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 14 19
Measure Type: Number
Unit of Measure: Participants
Very easy 6 7
Easy 5 7
Neither easy or difficult 3 3
Difficult 0 1
Very Difficult 0 1
11.Secondary Outcome
Title Palatability Questionnaire Assessment - Would You/Your Child Have Preferred This Medicine to Have Been Flavored, e.g. Fruity [Core Study]
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment.
Arm/Group Title Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 15 19
Measure Type: Number
Unit of Measure: Participants
Yes 4 9
No 2 5
Don't mind 9 5
12.Secondary Outcome
Title Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 19 22
Median (Full Range)
Unit of Measure: Percent change
Overall Seizures- Weeks 1-13
-58.74
(-100.0 to 75.8)
-39.59
(-100.0 to 759.3)
Overall Seizures- Weeks 14-26
-76.89
(-100.0 to 134.4)
-39.19
(-100.0 to 389.8)
Overall Seizures- Weeks 27-39; N=18, 20
-80.93
(-100.0 to 129.9)
-45.60
(-100.0 to 474.6)
Overall Seizures- Weeks 40-52; N=15, 15
-77.58
(-100.0 to -1.2)
-47.25
(-100.0 to 200.0)
Overall Partial Seizures- Weeks 1-13; N=14,19
-79.62
(-100.0 to 75.8)
-56.04
(-100.0 to 290.5)
Overall Partial Seizures- Weeks 14-26; N=14, 19
-78.69
(-100.0 to 134.4)
-67.30
(-100.0 to 87.9)
Overall Partial Seizures- Weeks 27-39; N=14, 17
-89.49
(-100.0 to 129.9)
-53.57
(-100.0 to 165.2)
Overall Partial Seizures- Weeks 40-52; N=14, 14
-89.89
(-100.0 to -1.2)
-39.46
(-100.0 to 100.0)
Overall Generalized Seizures- Weeks 1-13; N=11, 6
-63.96
(-100.0 to 465.5)
177.58
(-65.0 to 1065.4)
Overall Generalized Seizures- Weeks 14-26; N=11, 6
-79.08
(-100.0 to 440.7)
-14.13
(-87.3 to 389.8)
Overall Generalized Seizures- Weeks 27-39; N=10, 6
-73.93
(-100.0 to -8.9)
-4.77
(-83.6 to 474.6)
Overall Generalized Seizures- Weeks 40-52; N=7, 3
-76.91
(-100.0 to 182.8)
-5.86
(-61.5 to 700.0)
Unclassified Epileptic Seizure- Weeks 1-13; N=2, 1
-88.74
(-100.0 to 77.5)
-41.61
(-41.61 to -41.61)
Unclassified Epileptic Seizure- Weeks 14-26; N=2,1
-100.0
(-100.0 to -100.0)
-21.07
(-21.07 to -21.07)
Unclassified Epileptic Seizure- Weeks 27-39; N=2,1
-58.24
(-100.0 to -16.5)
6.81
(6.81 to 6.81)
Unclassified Epileptic Seizure- Weeks 40-52; N=2,1
-100.0
(-100.0 to -100.0)
-73.21
(-73.21 to -73.21)
13.Secondary Outcome
Title 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 19 22
Measure Type: Number
Unit of Measure: Percentage of responders
Overall Seizures- Weeks 1-13 57.9 45.5
Overall Seizures- Weeks 14-26 84.2 45.5
Overall Seizures- Weeks 27-39; N=18, 20 77.8 45.0
Overall Seizures- Weeks 40-52; N=15, 15 80.0 46.7
Overall Partial Seizures- Weeks 1-13; N=14,19 64.3 57.9
Overall Partial Seizures- Weeks 14-26; N=14, 19 85.7 57.9
Overall Partial Seizures- Weeks 27-39; N=14, 17 92.9 52.9
Overall Partial Seizures- Weeks 40-52; N=14, 14 71.4 42.9
Overall Generalized Seizures- Weeks 1-13; N=11, 6 72.7 16.7
Overall Generalized Seizures- Weeks 14-26; N=11, 6 81.8 33.3
Overall Generalized Seizures- Weeks 27-39; N=10, 6 70.0 16.7
Overall Generalized Seizures- Weeks 40-52; N=7, 3 71.4 33.3
Unclassified Epileptic Seizure- Weeks 1-13; N=2, 1 100.0 0.0
Unclassified Epileptic Seizure- Weeks 14-26; N=2,1 100.0 0.0
Unclassified Epileptic Seizure- Weeks 27-39; N=2,1 50.0 0.0
Unclassified Epileptic Seizure- Weeks 40-52; N=2,1 100.0 100.0
14.Secondary Outcome
Title Seizure-free Rate During the Overall Treatment Duration [Extension Phase]
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 19 22
Measure Type: Number
Unit of Measure: Percentage of participants
Overall Seizures- Weeks 1-13 21.1 22.7
Overall Seizures- Weeks 14-26;N=18, 20 22.2 30.0
Overall Seizures- Weeks 27-39; N=15, 15 13.3 33.3
Overall Seizures- Weeks 40-52; N=11, 11 27.3 36.4
Overall Partial Seizures- Weeks 1-13 52.6 40.9
Overall Partial Seizures- Weeks 14-26; N=18, 20 55.6 45.0
Overall Partial Seizures- Weeks 27-39; N=15, 15 33.3 40.0
Overall Partial Seizures- Weeks 40-52; N=11, 11 36.4 45.5
Overall Generalized Seizures- Weeks 1-13 57.9 72.7
Overall Generalized Seizures- Weeks 14-26; N=18,20 55.6 75.0
Overall Generalized Seizures- Weeks 27-39; N=15,15 66.7 80.0
Overall Generalized Seizures- Weeks 40-52; N=11,11 63.6 90.9
Unclassified Epileptic Seizure- Weeks 1-13 100.0 90.9
Unclassified Epileptic Seizure-Weeks 14-26;N=18,20 100.0 95.0
Unclassified Epileptic Seizure-Weeks 27-39;N=15,15 93.3 93.3
Unclassified Epileptic Seizure-Weeks 40-52;N=11,11 100.0 90.9
15.Secondary Outcome
Title The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 19 22
Measure Type: Number
Unit of Measure: Participants
Baseline- Normal, not at all ill 5 3
Baseline- Borderline mentally ill 0 0
Baseline- Mildly ill 3 4
Baseline- Moderately ill 10 10
Baseline- Markedly ill 1 4
Baseline- Severely ill 0 1
Baseline- Extremely ill 0 0
Week 11- Very much improved; N=19, 21 6 7
Week 11- Much improved; N=19, 21 8 7
Week 11- Minimally improved; N=19, 21 3 5
Week 11- No change; N= 19, 21 2 2
Week 11- Minimally worse; N=19, 21 0 0
Week 11- Much worse; N=19, 21 0 0
Week 11- Very much worse; N=19, 21 0 0
Week 28- Very much improved; N=18, 19 5 4
Week 28- Much improved; N=18, 19 7 8
Week 28- Minimally improved; N=18, 19 2 3
Week 28- No change; N=18, 19 4 3
Week 28- Minimally worse; N=18, 19 0 1
Week 28- Much worse; N=18, 19 0 0
Week 28- Very much worse; N=18, 19 0 0
Week 52- Very much improved; N=14, 12 1 3
Week 52- Much improved; N=14, 12 7 5
Week 52- Minimally improved; N=14, 12 4 4
Week 52- No change; N=14, 12 1 0
Week 52- Minimally worse; N=14, 12 0 0
Week 52- Much worse; N=14, 12 1 0
Week 52- Very much worse; N=14, 12 0 0
EOT- Very much improved 1 4
EOT- Much improved 8 9
EOT- Minimally improved 5 6
EOT- No change 4 2
EOT- Minimally worse 0 1
EOT- Much worse 1 0
EOT- Very much worse 0 0
16.Other Pre-specified Outcome
Title The Effect of Demographics on Population PK Parameters: AUC
Hide Description This outcome was not assessed in the study.
Time Frame 11 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome was not assessed in the study.
Arm/Group Title Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
17.Other Pre-specified Outcome
Title The Effect of Demographics on Population PK Parameters: Cmax
Hide Description This outcome was not assessed in the study.
Time Frame 11 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome was not assessed in the study.
Arm/Group Title Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Other Pre-specified Outcome
Title The Effect of Demographics on Population PK Parameters: Tmax
Hide Description This outcome was not assessed in the study.
Time Frame 11 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome was not assessed in the study.
Arm/Group Title Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
19.Other Pre-specified Outcome
Title The Effect of the Most Common Concomitant AEDs on Population PK Parameters: AUC
Hide Description This outcome was not assessed in the study.
Time Frame 11 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome was not assessed in the study.
Arm/Group Title Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
20.Other Pre-specified Outcome
Title The Effect of the Most Common Concomitant AEDs on Population PK Parameters: Cmax
Hide Description This outcome was not assessed in the study.
Time Frame 11 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome was not assessed in the study.
Arm/Group Title Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
21.Other Pre-specified Outcome
Title The Effect of the Most Common Concomitant AEDs on Population PK Parameters: Tmax
Hide Description This outcome was not assessed in the study.
Time Frame 11 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome was not assessed in the study.
Arm/Group Title Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
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
Adverse Event Reporting Description Treatment emergent AEs are presented in this section. 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/Group Title Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase
Hide Arm/Group Description 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 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. 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.
All-Cause Mortality
Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/22 (13.64%)   5/28 (17.86%)   6/19 (31.58%)   7/22 (31.82%) 
Cardiac disorders         
Cyanosis  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Congenital, familial and genetic disorders         
Developmental Hip Dysplasia  1  1/22 (4.55%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Gastrointestinal disorders         
Constipation  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Cyclic Vomiting Syndrome  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Infections and infestations         
Gastroenteritis  1  0/22 (0.00%)  1/28 (3.57%)  0/19 (0.00%)  1/22 (4.55%) 
Mastoiditis  1  0/22 (0.00%)  1/28 (3.57%)  0/19 (0.00%)  1/22 (4.55%) 
Otitis Externa  1  0/22 (0.00%)  1/28 (3.57%)  0/19 (0.00%)  1/22 (4.55%) 
Otitis Media Acute  1  0/22 (0.00%)  1/28 (3.57%)  0/19 (0.00%)  1/22 (4.55%) 
Pneumonia  1  0/22 (0.00%)  1/28 (3.57%)  0/19 (0.00%)  1/22 (4.55%) 
Respiratory Syncytial Virus Bronchiolitis  1  1/22 (4.55%)  0/28 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Septic Shock  1  0/22 (0.00%)  1/28 (3.57%)  0/19 (0.00%)  1/22 (4.55%) 
Otitis Media  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Investigations         
Anticonvulsant Drug Level Increased  1  0/22 (0.00%)  0/28 (0.00%)  0/19 (0.00%)  1/22 (4.55%) 
Metabolism and nutrition disorders         
Hypoglycaemia  1  0/22 (0.00%)  1/28 (3.57%)  0/19 (0.00%)  1/22 (4.55%) 
Dehydration  1  0/22 (0.00%)  0/28 (0.00%)  0/19 (0.00%)  1/22 (4.55%) 
Musculoskeletal and connective tissue disorders         
Foot Deformity  1  0/22 (0.00%)  0/28 (0.00%)  0/19 (0.00%)  1/22 (4.55%) 
Muscle Contracture  1  0/22 (0.00%)  0/28 (0.00%)  0/19 (0.00%)  1/22 (4.55%) 
Nervous system disorders         
Convulsion  1  0/22 (0.00%)  1/28 (3.57%)  2/19 (10.53%)  1/22 (4.55%) 
Status Epilepticus  1  0/22 (0.00%)  0/28 (0.00%)  0/19 (0.00%)  2/22 (9.09%) 
Psychiatric disorders         
Abnormal Behaviour  1  0/22 (0.00%)  1/28 (3.57%)  0/19 (0.00%)  0/22 (0.00%) 
Mental Status Changes  1  1/22 (4.55%)  0/28 (0.00%)  2/19 (10.53%)  0/22 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pleural Effusion  1  0/22 (0.00%)  1/28 (3.57%)  0/19 (0.00%)  1/22 (4.55%) 
Respiratory Failure  1  0/22 (0.00%)  1/28 (3.57%)  0/19 (0.00%)  1/22 (4.55%) 
Vascular disorders         
Hypotension  1  0/22 (0.00%)  1/28 (3.57%)  0/19 (0.00%)  1/22 (4.55%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   22/22 (100.00%)   25/28 (89.29%)   19/19 (100.00%)   22/22 (100.00%) 
Blood and lymphatic system disorders         
Anaemia  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Neutropenia  1  0/22 (0.00%)  0/28 (0.00%)  0/19 (0.00%)  2/22 (9.09%) 
Thrombocytopenia  1  0/22 (0.00%)  0/28 (0.00%)  2/19 (10.53%)  1/22 (4.55%) 
Cardiac disorders         
Bradycardia  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Congenital, familial and genetic disorders         
Phimosis  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Ear and labyrinth disorders         
Ear Pain  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Eye disorders         
Conjunctivitis  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  1/22 (4.55%) 
Eye Irritation  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Ocular Hyperaemia  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  1/22 (4.55%) 
Photophobia  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Gastrointestinal disorders         
Abdominal Pain Upper  1  0/22 (0.00%)  4/28 (14.29%)  0/19 (0.00%)  5/22 (22.73%) 
Vomiting  1  3/22 (13.64%)  5/28 (17.86%)  4/19 (21.05%)  6/22 (27.27%) 
Abdominal Pain  1  0/22 (0.00%)  0/28 (0.00%)  0/19 (0.00%)  2/22 (9.09%) 
Aphthous Stomatitis  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Constipation  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  1/22 (4.55%) 
Diarrhoea  1  0/22 (0.00%)  0/28 (0.00%)  3/19 (15.79%)  1/22 (4.55%) 
Flatulence  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Gingival Recession  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Nausea  1  0/22 (0.00%)  0/28 (0.00%)  2/19 (10.53%)  2/22 (9.09%) 
Oral Mucosal Discolouration  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
General disorders         
Fatigue  1  1/22 (4.55%)  8/28 (28.57%)  1/19 (5.26%)  6/22 (27.27%) 
Gait Disturbance  1  2/22 (9.09%)  1/28 (3.57%)  2/19 (10.53%)  0/22 (0.00%) 
Irritability  1  3/22 (13.64%)  5/28 (17.86%)  3/19 (15.79%)  5/22 (22.73%) 
Pyrexia  1  8/22 (36.36%)  4/28 (14.29%)  8/19 (42.11%)  7/22 (31.82%) 
Immune system disorders         
Autoimmune Disorder  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Hypersensitivity  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Infections and infestations         
Ear Infection  1  0/22 (0.00%)  2/28 (7.14%)  3/19 (15.79%)  4/22 (18.18%) 
Otitis Media  1  2/22 (9.09%)  2/28 (7.14%)  2/19 (10.53%)  3/22 (13.64%) 
Upper Respiratory Tract Infection  1  3/22 (13.64%)  2/28 (7.14%)  5/19 (26.32%)  6/22 (27.27%) 
Atypical Pneumonia  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Bronchitis  1  0/22 (0.00%)  0/28 (0.00%)  0/19 (0.00%)  2/22 (9.09%) 
Clostridium Difficile Infection  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Fungal Skin Infection  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Gastroenteritis Viral  1  0/22 (0.00%)  0/28 (0.00%)  2/19 (10.53%)  1/22 (4.55%) 
Influenza  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  1/22 (4.55%) 
Lice Infestation  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  1/22 (4.55%) 
Nasopharyngitis  1  0/22 (0.00%)  0/28 (0.00%)  3/19 (15.79%)  3/22 (13.64%) 
Pharyngitis  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  3/22 (13.64%) 
Sinusitis  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  1/22 (4.55%) 
Tinea Capitis  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Urinary Tract Infection  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Viral Rash  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Injury, poisoning and procedural complications         
Fall  1  2/22 (9.09%)  1/28 (3.57%)  2/19 (10.53%)  1/22 (4.55%) 
Contusion  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Epiphyseal Fracture  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Head Injury  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Laceration  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Ligament Sprain  1  0/22 (0.00%)  0/28 (0.00%)  0/19 (0.00%)  2/22 (9.09%) 
Investigations         
Thyroxine Decreased  1  0/22 (0.00%)  2/28 (7.14%)  0/19 (0.00%)  2/22 (9.09%) 
Weight Increased  1  1/22 (4.55%)  3/28 (10.71%)  1/19 (5.26%)  4/22 (18.18%) 
Blood Bicarbonate Decreased  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Blood Sodium Decreased  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Blood Triglycerides Increased  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Blood Uric Acid Decreased  1  0/22 (0.00%)  0/28 (0.00%)  2/19 (10.53%)  1/22 (4.55%) 
Cardiac Murmur  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Cardiac Murmur Functional  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Globulins Decreased  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Heart Rate Increased  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Tri-Iodothyronine Decreased  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Weight Decreased  1  0/22 (0.00%)  0/28 (0.00%)  2/19 (10.53%)  1/22 (4.55%) 
Metabolism and nutrition disorders         
Decreased Appetite  1  1/22 (4.55%)  2/28 (7.14%)  2/19 (10.53%)  1/22 (4.55%) 
Increased Aappetite  1  0/22 (0.00%)  3/28 (10.71%)  1/19 (5.26%)  4/22 (18.18%) 
Dehydration  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Hypernatraemia  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Metabolic Acidosis  1  0/22 (0.00%)  0/28 (0.00%)  2/19 (10.53%)  0/22 (0.00%) 
Vitamin D Deficiency  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Musculoskeletal and connective tissue disorders         
Myalgia  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Pain In Extremity  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Posture Abnormal  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Nervous system disorders         
Ataxia  1  0/22 (0.00%)  2/28 (7.14%)  0/19 (0.00%)  2/22 (9.09%) 
Balance Disorder  1  1/22 (4.55%)  2/28 (7.14%)  1/19 (5.26%)  1/22 (4.55%) 
Dizziness  1  3/22 (13.64%)  2/28 (7.14%)  3/19 (15.79%)  2/22 (9.09%) 
Headache  1  1/22 (4.55%)  2/28 (7.14%)  2/19 (10.53%)  3/22 (13.64%) 
Lethargy  1  1/22 (4.55%)  2/28 (7.14%)  4/19 (21.05%)  3/22 (13.64%) 
Psychomotor Hyperactivity  1  0/22 (0.00%)  2/28 (7.14%)  0/19 (0.00%)  0/22 (0.00%) 
Somnolence  1  4/22 (18.18%)  3/28 (10.71%)  3/19 (15.79%)  3/22 (13.64%) 
Tremor  1  0/22 (0.00%)  2/28 (7.14%)  0/19 (0.00%)  0/22 (0.00%) 
Cognitive Disorder  1  0/22 (0.00%)  0/28 (0.00%)  2/19 (10.53%)  0/22 (0.00%) 
Drooling  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Dyskinesia  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Hypotonia  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Intention Tremor  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Sedation  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Speech Disorder  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Psychiatric disorders         
Aggression  1  3/22 (13.64%)  1/28 (3.57%)  5/19 (26.32%)  2/22 (9.09%) 
Anxiety  1  2/22 (9.09%)  0/28 (0.00%)  2/19 (10.53%)  0/22 (0.00%) 
Insomnia  1  1/22 (4.55%)  2/28 (7.14%)  1/19 (5.26%)  2/22 (9.09%) 
Oppositional Defiant Disorder  1  2/22 (9.09%)  1/28 (3.57%)  2/19 (10.53%)  1/22 (4.55%) 
Tearfulness  1  2/22 (9.09%)  0/28 (0.00%)  2/19 (10.53%)  0/22 (0.00%) 
Abnormal Behaviour  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  1/22 (4.55%) 
Agitation  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Depressed Mood  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  1/22 (4.55%) 
Disorientation  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Echolalia  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Emotional Disorder  1  0/22 (0.00%)  0/28 (0.00%)  2/19 (10.53%)  0/22 (0.00%) 
Hallucination  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Mood Altered  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Mood Swings  1  0/22 (0.00%)  0/28 (0.00%)  0/19 (0.00%)  2/22 (9.09%) 
Sleep Disorder  1  0/22 (0.00%)  0/28 (0.00%)  2/19 (10.53%)  1/22 (4.55%) 
Suicidal Ideation  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  2/22 (9.09%) 
Renal and urinary disorders         
Dysuria  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Enuresis  1  0/22 (0.00%)  0/28 (0.00%)  0/19 (0.00%)  2/22 (9.09%) 
Haematuria  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Proteinuria  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Reproductive system and breast disorders         
Vulval Disorder  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  3/22 (13.64%)  1/28 (3.57%)  4/19 (21.05%)  2/22 (9.09%) 
Nasal Congestion  1  2/22 (9.09%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Rhinorrhoea  1  2/22 (9.09%)  0/28 (0.00%)  3/19 (15.79%)  1/22 (4.55%) 
Asthma  1  0/22 (0.00%)  0/28 (0.00%)  2/19 (10.53%)  0/22 (0.00%) 
Epistaxis  1  0/22 (0.00%)  0/28 (0.00%)  2/19 (10.53%)  1/22 (4.55%) 
Grunting  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Oropharyngeal Pain  1  0/22 (0.00%)  0/28 (0.00%)  0/19 (0.00%)  2/22 (9.09%) 
Rhinitis Allergic  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  1/22 (4.55%) 
Skin and subcutaneous tissue disorders         
Dermatitis Contact  1  1/22 (4.55%)  2/28 (7.14%)  1/19 (5.26%)  2/22 (9.09%) 
Eczema  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  1/22 (4.55%) 
Rash  1  0/22 (0.00%)  0/28 (0.00%)  2/19 (10.53%)  1/22 (4.55%) 
Skin Disorder  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Urticaria  1  0/22 (0.00%)  0/28 (0.00%)  2/19 (10.53%)  0/22 (0.00%) 
Vascular disorders         
Hypotension  1  0/22 (0.00%)  0/28 (0.00%)  1/19 (5.26%)  0/22 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eisai Medical Services
Organization: Eisai, Inc.
Phone: 1-888-422-4743
EMail: esi_medinfo@eisai.com
Layout table for additonal information
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01527006     History of Changes
Other Study ID Numbers: E2007-G000-232
First Submitted: November 10, 2011
First Posted: February 6, 2012
Results First Submitted: July 31, 2015
Results First Posted: August 28, 2015
Last Update Posted: July 12, 2016