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Perampanel as Adjunctive Therapy in Pediatrics With Partial Onset Seizures or Primary Generalized Tonic Clonic Seizures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02849626
Recruitment Status : Active, not recruiting
First Posted : July 29, 2016
Results First Posted : April 6, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Brief Summary:
This is an open-label, multicenter study with an Extension Phase to evaluate the safety and tolerability of perampanel oral suspension when administered as an adjunctive therapy in children (ages 4 to less than [<] 12 years) with inadequately controlled partial onset seizures (POS) or primary generalized tonic clonic (PGTC) seizures.

Condition or disease Intervention/treatment Phase
Partial-Onset or Primary Generalized Tonic-Clonic Seizures Drug: Perampanel Phase 3

Detailed Description:
This is a multicenter, open-label, single-arm study in children (age 4 to <12 years) with inadequately controlled POS or PGTC seizures. The study will consist of a Core Phase and two Extension Phases (Extension Phase A [for all countries in the study], and Extension Phase B [available for participants enrolled in Japan and in countries where an extended access program {EAP} cannot be implemented, after completion of Extension Phase A]). The Core Phase will consist of the following 2 phases: Pretreatment and Treatment Phase. The Pretreatment Phase, during which participants will be assessed for eligibility, will consist of up to a 4-weeks +/- 3 days Screening/Baseline Period. The Treatment Phase will consist of 3 periods: Titration Period (up to an 11-weeks: dose titration on the basis of individual clinical response and tolerability), Maintenance Period (up to a 12-weeks: continuation of perampanel oral suspension once daily at the dose level achieved at the end of the Titration Period), and Follow-up Period (up to 4-weeks +/- 7 days: only for those participants not entering into Extension Phase A or those who prematurely discontinue from the study). Extension Phase A will consist of up to 29-weeks Maintenance Period and up to 4-weeks +/- 7 days Follow-up Period after the last dose of perampanel only for participants who did not enter into Extension Phase B. All participants who complete all scheduled visits up to and including Visit 9 in the Treatment Phase will be eligible to participate in Extension Phase A of the study. During the Maintenance Period of Extension Phase A, all participants will continue with their optimal perampanel dose (that is, dose level that they complete on during the Core Phase). After completing Extension Phase A, participants in Japan and in countries where EAP cannot be implemented, participants will be eligible to participate in Extension Phase B. In Japan, treatment will continue as long as clinically appropriate according to the judgment of the investigator. However, treatment of participants in Extension B will be completed when the participant reaches 12 years of age or when perampanel is commercially available in Japan for treatment of POS in pediatric participants (4 to less than 12 years of age). In countries where an EAP cannot be implemented, participation in Extension B will continue as long as clinically appropriate according to the judgment of the investigator, until the participants reaches 12 years of age or perampanel oral suspension is commercially available.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter Study With an Extension Phase to Evaluate the Safety, Tolerability, and Exposure-Efficacy Relationship of Perampanel Oral Suspension When Administered as an Adjunctive Therapy in Pediatric Subjects (Age 4 to Less Than 12 Years) With Inadequately Controlled Partial-Onset Seizures or Primary Generalized Tonic Clonic Seizures
Actual Study Start Date : November 16, 2016
Actual Primary Completion Date : February 5, 2019
Estimated Study Completion Date : December 11, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
Drug Information available for: Perampanel

Arm Intervention/treatment
Experimental: Perampanel
Perampanel 0.5 milligrams per milliliter (mg/mL) oral suspension
Drug: Perampanel
E2007




Primary Outcome Measures :
  1. Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) for Total Group of Participants- Core Phase and Extension Phase A of This Study [ Time Frame: Baseline up to 4 weeks (follow up in Extension Phase A) after last dose of study drug in Extension Phase A at Week 52 (up to 56 weeks) ]
  2. Percentage of Participants With Treatment Emergent Markedly Abnormal Laboratory Values for Total Group of Participants- Core Phase and Extension Phase A of This Study [ Time Frame: Baseline up to 52 weeks ]
  3. Percentage of Participants With Abnormal Vital Sign Values for Total Group of Participants- Core Phase and Extension Phase A of This Study [ Time Frame: Baseline up to 52 weeks ]
    Pre-defined criteria of vital signs abnormalities: maximum (max.) increase or decrease from baseline in sitting/supine systolic blood pressure (SBP) of greater than or equal to (>=) 20 or 40 millimeter of mercury (mmHg); maximum increase or decrease from baseline in sitting/supine diastolic blood pressure (DBP) >=10 or 20 mmHg; increase or decrease from baseline in pulse rate (number of heart beats per minute [bpm]) of >=15 or 30 bpm. Data for this outcome measure has been assessed and reported till Week 52.

  4. Percentage of Participants With Markedly Abnormal Electrocardiogram (ECG) Parameters for Total Group of Participants- Core Phase and Extension Phase A of This Study [ Time Frame: Baseline up to 52 weeks ]

Secondary Outcome Measures :
  1. Model Predicted Percent Change in Average Seizure Frequency Over 28 Days During Maintenance Period in Core Phase of This Study From Baseline- Assessed as Relationship With Average Steady State Plasma Concentration (Cav, ss) of Perampanel (518 ng/mL) [ Time Frame: Baseline, Week 23 ]
    Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated as the number of seizures divided by the number of days in the interval and multiplied by 28. Due to the sparse pharmacokinetic (PK) sampling in this study, the data of this outcome measure was analyzed by pooling the data from other Phase II and III studies of perampanel along with the data of this current study, including participants with POS or PGTC. Only data for participants taking perampanel 8 mg/day (corresponding to Cav, ss of 518 ng/mL) were reported. Participants taking perampanel 12 mg/day in the studies from which data were pooled, were not included in analysis for this measure. Here, ng/mL refers to nanogram per milliliter. Data for this measure was calculated through model prediction and reported as "percent change" with measure type as "number" and measure dispersion as "Not applicable, NA".

  2. Overall Responder Probability For Non-Asian Participants With POS During Core Phase of This Study: Assessment Based on Relationship With Average Steady State Plasma Concentration (Cav, ss) of Perampanel [ Time Frame: Baseline up to 23 weeks ]
    For this outcome measure, responders were those who experienced a 50 percent (%) or greater reduction in seizure frequency per 28 days from baseline. Due to the sparse PK sampling in this study, the data of this outcome measure were pooled with data from other Phase III studies of perampanel conducted in participants with POS. "AEDs not affecting PK" refers to AEDs not affecting PK of perampanel. Data for this outcome measure has been reported for only non-Asian participants with POS per age groups. Responder probability has been reported for Cav,ss of perampanel when given along with different antiepileptic drugs (AEDs).

  3. Overall Responder Probability For Participants With PGTC Seizures During Core Phase of This Study: Assessment Based on Relationship With Average Steady State Plasma Concentration (Cav, ss) of Perampanel [ Time Frame: Baseline up to 23 weeks ]
    For this outcome measure, responders were those who experienced a 50% or greater reduction in seizure frequency per 28 days from baseline. Due to the sparse PK sampling in this study, the data of this outcome measure were analyzed by pooling the data from other Phase II and III studies of perampanel along with data of this current study, including participants with PGTC seizures. In this outcome measure, responder probability at different concentration values of perampanel when given with or without topiramate (an antiepileptic) has been reported.

  4. Number of Seizure Free Observations During Core Phase of This Study: Assessment Based on Relationship With Average Steady State Plasma Concentration (Cav, ss) of Perampanel [ Time Frame: Baseline up to Week 23 ]
    Due to the sparse PK sampling in this study, the data of this outcome measure were analyzed by pooling data from other Phase II and III studies of perampanel along with this current study, including participants with POS or PGTC. Data for this outcome measure have been reported in relationship with different ranges of Cav, ss of Perampanel as "number of observations" those were seizure free for up to 3 visits. The reason for using number of observations for analysis of this outcome measure was because data were available as up to 3 visits per participant and not necessarily that the participant was seizure-free on all three visits.

  5. Model Predicted Change From Baseline in Total Aldenkamp-Baker Neuropsychological Assessment Schedule (ABNAS) Score During Core Phase of This Study: Assessment Based on Relationship With Plasma Levels of Perampanel [ Time Frame: Baseline up to Week 23 ]
    The ABNAS assessment measured 5 aspects of cognitive function such as fatigue, memory, concentration, motor speed, and reading. The assessment was a measure of participant-perceived cognitive effects of AEDs. This instrument was aimed at assessing participant perceived drug-related cognitive impairment. Total score ranged from 0-72. Higher scores indicate a worsening of these cognitive functions. Analysis for this outcome measure was planned to be performed via Pharmacokinetic/Pharmacodynamic (PK/PD) modelling only if a graphical relationship between perampanel exposure and change from baseline in ABNAS could be discerned.

  6. Model Predicted Change From Baseline in Total Child Behavior Check List (CBCL) Score (Participants Aged 4 to 5 Years) During Core Phase of This Study: Assessment Based on Relationship With Plasma Levels of Perampanel [ Time Frame: Baseline up to Week 23 ]
    The CBCL for participants with age 4 to 5 years is a questionnaire to assess behavioral and emotional problems in children as reported by the primary caregiver for the following domains activities: emotionally reactive, anxious/depressed, withdrawn, somatic complaints, internalizing, attention problems, aggressive behavior, externalizing, sleep problems. CBCL total score for participants with age 4 to 5 years ranged from 0 to 200, was calculated by adding individual score of each domain. Higher scores indicate greater problems in child behavior. Analysis for this outcome measure was planned to be performed via PK/PD modelling only if a graphical relationship between perampanel exposure and change from baseline in CBCL score (participants aged 4 to 5 years) could be discerned.

  7. Model Predicted Change From Baseline in Total Child Behavior Check List (CBCL) Score (Participants Aged Greater Than [>] 5 to <12 Years) During Core Phase of This Study: Assessment Based on Relationship With Plasma Levels of Perampanel [ Time Frame: Baseline up to Week 23 ]
    The CBCL for participants with age >5 to <12 years is a questionnaire to assess behavioral and emotional problems in children as reported by the primary caregiver for the following domains activities: activity, social, school, total competence, anxious/depressed, withdrawn/depressed, somatic complaints, internalizing, rule-breaking behavior, aggressive behavior, externalizing, social problems, thought problems, attention problems. CBCL total score for participants with age >5 to <12 years ranged from 0 to 240, was calculated by adding individual score of each domain. Higher scores indicate greater problems in child behavior. Analysis for this outcome measure was planned to be performed via PK/PD modelling only if a graphical relationship between perampanel exposure and change from baseline in CBCL score (participants aged >5 to <12 years) could be discerned.

  8. Model Predicted Change From Baseline in Total Time to Complete LGPT Score for Dominant Hand in Core Phase of This Study for All Participants Aged 4 to <12 Years: Assessment Based on Relationship With Plasma Levels of Perampanel [ Time Frame: Baseline up to Week 23 ]
    The Lafayette Grooved Pegboard Test (LGPT) measures visuomotor skills. This test is a manipulative dexterity test that consist of a metal matrix of 25 holes with randomly positioned slots. Participants require to insert 10 grooved pegs into the holes. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. The task is timed and the scores are the time taken for the participant to complete all 10 pegs for each hand. If the test cannot be completed within 300 seconds, 300 seconds are recorded for the time. An increase in score (longer time) indicate worsening of visuomotor skills. Analysis for this outcome measure was planned to be performed via PK/PD modelling only if a graphical relationship between perampanel exposure and change from baseline in Total Time to Complete LGPT Score for Dominant Hand could be discerned.

  9. Model Predicted Change From Baseline in Total Time to Complete LGPT Score for Non-dominant Hand in Core Phase of This Study for All Participants Aged 4 to <12 Years: Assessment Based on Relationship With Plasma Levels of Perampanel [ Time Frame: Baseline up to Week 23 ]
    The Lafayette Grooved Pegboard Test (LGPT) measures visuomotor skills. This test is a manipulative dexterity test that consist of a metal matrix of 25 holes with randomly positioned slots. Participants require to insert 10 grooved pegs into the holes. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. The task is timed and the scores are the time taken for the participant to complete all 10 pegs for each hand. If the test cannot be completed within 300 seconds, 300 seconds are recorded for the time. An increase in score (longer time) indicate worsening of visuomotor skills. Analysis for this outcome measure was planned to be performed via PK/PD modelling only if a graphical relationship between perampanel exposure and change from baseline in Total Time to Complete LGPT Score for Non-dominant Hand could be discerned.

  10. Percentage of Participants With Most Frequent Treatment Emergent Adverse Events (AEs) for Total Group of Participants That Were Considered Related to Perampanel- Core Phase of This Study [ Time Frame: Baseline up to 23 weeks ]
  11. Change From Baseline in Aldenkamp-Baker Neuropsychological Assessment Schedule (ABNAS) Score as Per Seizure Type at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study [ Time Frame: Baseline, Week 23, Week 52 ]
    The ABNAS assessment measured 5 aspects of cognitive function such as fatigue, memory, concentration, motor speed, and reading. The assessment was a measure of participant-perceived cognitive effects of AEDs. This instrument was aimed at assessing participant perceived drug-related cognitive impairment. Total score ranged from 0-72. Higher scores indicate a worsening of these cognitive functions.

  12. Change From Baseline in Total Child Behavior Check List (CBCL) Score (Age Group 1.5 to 5 Years) as Per Seizure Type at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study [ Time Frame: Baseline, Week 23, Week 52 ]
    The CBCL for participants (age group 1.5 to 5 years) is a questionnaire to assess behavioral and emotional problems in children as reported by the primary caregiver for the following domains activities: emotionally reactive, anxious/depressed, withdrawn, somatic complaints, internalizing, attention problems, aggressive behavior, externalizing, sleep problems. CBCL total score for participants (age group 1.5 to 5 years) ranged from 0 to 200, was calculated by adding individual score of each domain. Higher scores indicate greater problems in child behavior.

  13. Change From Baseline in Total Child Behavior Check List (CBCL) Score (Age Group 6 to 18 Years) as Per Seizure Type at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study [ Time Frame: Baseline, Week 23, Week 52 ]
    The CBCL for participants (age group 6 to 18 years) is a questionnaire to assess behavioral and emotional problems in children as reported by the primary caregiver for the following domains activities: activity, social, school, total competence, anxious/depressed, withdrawn/depressed, somatic complaints, internalizing, rule-breaking behavior, aggressive behavior, externalizing, social problems, thought problems, attention problems. CBCL total score for participants (age group 6 to 18 years) ranged from 0 to 240, was calculated by adding individual score of each domain. Higher scores indicate greater problems in child behavior.

  14. Change From Baseline in Time to Complete Lafayette Grooved Pegboard Test (LGPT) Scores for 8 Years and Under as Per Seizure Type at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study [ Time Frame: Baseline, Week 23, Week 52 ]
    The LGPT test measured visuomotor skills. This test was a manipulative dexterity test that consisted of a metal matrix of 25 holes with randomly positioned slots. The participant was required to insert 10 grooved pegs into the holes. The task was completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. The task was timed and the scores were the time taken for the participant to complete all 10 pegs for each hand. If the test cannot be completed within 300 seconds, 300 seconds were recorded for the time. An increase in score (longer time) indicated worsening of visuomotor skills. The time to complete test is presented as mean seconds plus/minus (+/-) SD.

  15. Change From Baseline in Time to Complete Lafayette Grooved Pegboard Test (LGPT) Scores Over 8 Years as Per Seizure Type at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study [ Time Frame: Baseline, Week 23, Week 52 ]
    The LGPT test measured visuomotor skills. This test was a manipulative dexterity test that consisted of a metal matrix of 25 holes with randomly positioned slots. The participant was required to insert 25 grooved pegs into the holes. The task was completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. The task was timed and the scores were the time taken for the participant to complete all 25 pegs for each hand. If the test cannot be completed within 300 seconds, 300 seconds were recorded for the time. An increase in score (longer time) indicated worsening of visuomotor skills. The time to complete test is presented as mean seconds +/- SD.

  16. Change From Baseline in Height (a Growth and Development Parameter) at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study [ Time Frame: Baseline, Week 23, Week 52 ]
  17. Change From Baseline in Weight (a Growth and Development Parameter) at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study [ Time Frame: Baseline, Week 23, Week 52 ]
  18. Change From Baseline in Thyrotropin Value (a Growth and Development Parameter) at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study [ Time Frame: Baseline, Week 23, Week 52 ]
    Thyrotropin level was measured in milli-international units per liter (mIU/L).

  19. Change From Baseline in Thyroxine, Free and Triiodothyronine, Free Values (Growth and Development Parameters) at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study [ Time Frame: Baseline, Week 23, Week 52 ]
  20. Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Values (a Growth and Development Parameter) at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study [ Time Frame: Baseline, Week 23, Week 52 ]
  21. Percentage of Participants With Change From Baseline in Markedly Abnormal Encephalogram (EEG) Parameter Values During Awake and Sleep State for Total Group of Participant: Core Phase and Extension Phase A of This Study [ Time Frame: Baseline up to 52 weeks ]
  22. Number of Encephalogram (EEG) Abnormalities During Awake and Sleep State for Total Group of Participant: Core Phase and Extension Phase A of This Study [ Time Frame: Baseline up to 52 weeks ]
  23. Percentage of Participants With Any Treatment-emergent Reports of Suicidal Ideation and Behavior Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)- Core Phase and Extension Phase A of This Study [ Time Frame: Up to 52 weeks ]
    The C-SSRS: interview-based instrument to systematically assess suicidal ideation (SI) and suicidal behavior, to assess whether participant experienced any of the following: completed suicide, suicide attempt (response of "yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior ("yes" on "preparatory acts or behavior", "aborted attempt" or "interrupted attempt"), suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active SI with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any self-injurious behavior with no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior"). Here, percentage of participants with >=1 positive behavior, participants with >=1 positive ideations, and suicidality were reported. An assessment of SI and behavior using the C-SSRS was performed for participants >=6 years at the time of consent.

  24. Percentage of Participants With Shift From Baseline in Suicidal Ideation and Behaviors Assessed Using C-SSRS Scores to Extension Phase A (Week 52) of This Study [ Time Frame: Up to 52 weeks ]
    The C-SSRS: interview-based instrument to systematically assess suicidal ideation (SI) and suicidal behavior, to assess whether participant experienced any of the following: completed suicide, suicide attempt (response of "yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior ("yes" on "preparatory acts or behavior", "aborted attempt" or "interrupted attempt"), suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active SI with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any self-injurious behavior with no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior"). "w/" refers to "with", "W" refers to "Week" and "&" refers to "and"

  25. Median Percent Change in Seizure Frequency Per 28 Days During the Treatment Phase Relative to the Pretreatment Phase (Baseline)- Core Phase and Extension Phase A of This Study [ Time Frame: Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52 ]
    Seizure frequency was based on number of seizures per 28 days, calculated as number of seizures over entire time interval divided by number of days in interval and multiplied by 28. Total POS: sum of all POS including simple partial seizures without motor signs, simple partial seizures with motor signs, complex partial seizures, and complex partial seizures with secondary generalization (SG). Data for this measure has been reported for 13 week time periods as per age groups.

  26. Percentage of Participants Based on 25% Responder Rate- Core Phase and Extension Phase A of This Study [ Time Frame: Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52 ]
    A 25% responder was a participant who experienced a 25% or greater reduction in seizure frequency per 28 days from baseline. Total POS: sum of all POS including simple partial seizures without motor signs, simple partial seizures with motor signs, complex partial seizures, and complex partial seizures with SG. Data for this outcome measure has been reported for 13 week time periods as per age groups.

  27. Percentage of Participants Based on 50% Responder Rate- Core Phase and Extension Phase A of This Study [ Time Frame: Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52 ]
    A 50% responder was a participant who experienced a 50% or greater reduction in seizure frequency per 28 days from baseline. Total POS: sum of all POS including simple partial seizures without motor signs, simple partial seizures with motor signs, complex partial seizures, and complex partial seizures with SG. Data for this outcome measure has been reported for 13 week time periods as per age groups.

  28. Percentage of Participants Based on 75% Responder Rate- Core Phase and Extension Phase A of This Study [ Time Frame: Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52 ]
    A 75% responder was a participant who experienced a 75% or greater reduction in seizure frequency per 28 days from baseline. Total POS: sum of all POS including simple partial seizures without motor signs, simple partial seizures with motor signs, complex partial seizures, and complex partial seizures with SG. Data for this outcome measure has been reported for 13 week time periods as per age groups.

  29. Percentage of Participants Who Were Seizure-free- Core Phase and Extension Phase A of This Study [ Time Frame: Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52 ]
    Participants were considered seizure free if participants completed a 13-week time period and were seizure-free for that entire time period. Total POS: sum of all POS including simple partial seizures without motor signs, simple partial seizures with motor signs, complex partial seizures, and complex partial seizures with SG. Data for this outcome measure has been reported for 13 week time periods as per age groups.

  30. Percentage of Participants With Clinical Global Impression of Change Scores (CGIC)- Core Phase and Extension Phase A of This Study [ Time Frame: Baseline, Week 23, Week 52 ]
    Assessment of disease severity utilized the CGIC scale at end of treatment to evaluate participant's change in disease status from baseline. The CGIC is a 7-point scale that measures a physician's global impression of a participant's clinical condition. Scale ranged from 1 to 7 with lower score indicated improvement (1=very much improved, 2=much improved, 3=minimally improved), higher score indicated worsening (5=minimally worse, 6= much worse, 7=very much worse), and a score of 4 indicated no change.



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Layout table for eligibility information
Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of epilepsy with POS with or without secondarily generalized (SG) seizures or PGTC seizures according to the International League Against Epilepsy's (ILAE) Classification of Epileptic Seizures (1981). A diagnosis should have been established at least 6 months prior to Visit 1 by clinical history and an electroencephalogram (EEG) that is consistent with the diagnosis; normal interictal EEGs will be allowed provided that the participant meets the other diagnosis criterion (that is, clinical history)
  • Male or female participant, from age 4 to <12 years at the time of informed consent/assent
  • Have a minimum weight of 16 kilograms (kg) (35 pounds [lb])
  • Have had a brain imaging (example, magnetic resonance imaging [MRI] scan or computed tomography [CT] before Visit 1 that ruled out a progressive cause of epilepsy)
  • During the 12 weeks +/- 3 days (4 weeks +/- 3 days in Japan only) prior to Visit 2, participants must have equal or greater than (=>) one POS or one PGTC seizure. Only simple POS with motor signs, complex POS, and complex POS with secondary generalization are counted toward this inclusion for POS
  • Are currently being treated with stable doses of 1 to a maximum of 3 approved antiepileptic drugs (AEDs). Doses must be stable for at least 4 weeks before to Visit 1; in the case where a new AED regimen has been initiated for a participant, the dose must be stable for at least 8 weeks prior to Visit 1. Only one EIAED (defined as carbamazepine, phenytoin, oxcarbazepine, or eslicarbazepine) out of the maximum of three AEDs is allowed (A vagal nerve stimulator [VNS] will be counted as one of the 3 allowed AEDs)

Exclusion Criteria:

  • Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta human chorionic gonadotropin [β-hCG] or human chorionic gonadotropin [hCG] test with a minimum sensitivity of 25 International Units per liter [IU/L] or equivalent units of β-hCG or hCG). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug
  • Females of childbearing potential who:

    • Had unprotected sexual intercourse within 30 days before study entry and who do not agree to use a highly effective method of contraception (example, total abstinence, an intrauterine device, a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period or for 28 days after study drug discontinuation. If a highly effective method is not appropriate or acceptable for the participant, then the participant may use a medically effective method (example, a double barrier method such as condom plus diaphragm with spermicide)
    • Are currently abstinent, and do not agree to use a double-barrier method (as described above) or refrain from being sexually active during the study period or for 28 days after study drug discontinuation
    • Are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and who do not agree to use the same contraceptive during the study or for 28 days after study drug discontinuation
  • Current or history of pseudo-seizures (psychogenic nonepileptic seizures) within approximately 5 years before Visit 1
  • Have a history of status epilepticus that required hospitalization during the 6 months before Visit 1
  • Have an unstable psychiatric diagnosis that may confound participants' ability to participate in the study or that may prevent completion of the protocol-specified tests (example, significant suicide risk, including suicidal behavior and ideation within 6 months before Visit 1, current psychotic disorder, acute mania)
  • Any suicidal ideation with intent with or without a plan within 6 months before Visit 2 (that is, answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale [C-SSRS]) in participants aged 6 and above
  • 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
  • Evidence of clinically significant disease (example, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments
  • Evidence of moderate or severe renal insufficiency as defined by estimated glomerular filtration rates (eGFRs) of 31 to <60 milliliters per minute (mL/min) and <30 mL/min, respectively
  • Evidence of significant active hepatic disease. Stable elevation of liver enzymes, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) due to concomitant medication(s), will be allowed if they are less than 3 times the upper limit of normal (ULN)
  • Evidence of significant active hematological disease; white blood cell (WBC) count equal or less than (=<) 2500 per (/) microliter (µL) (2.50 1 constant [E]+09/liter [L]) or an absolute neutrophil count =<1000/µL (1.00 1E+09/L)
  • Clinically significant electrocardiogram (ECG) abnormality, including prolonged corrected QT interval (QTc) defined as greater than (>) 450 milliseconds (msec)
  • Have a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors
  • Multiple drug allergies or a severe drug reaction to an AED(s), including dermatological (example, Stevens Johnson syndrome), hematological, or organ toxicity reactions.
  • Concomitant use of felbamate as an AED for <2 years or where the dose has not been stable for at least 8 weeks before Visit 1. Participants must not have a history of WBC count =<2500/µL, platelets below 100,000, liver function tests (LFTs) above 3 times the 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 before Visit 1 to be eligible for study participation
  • Concomitant use of vigabatrin: participants who took vigabatrin in the past must be off vigabatrin for at least 5 months before Visit 1 and with documentation showing no evidence of a vigabatrin-associated clinically significant abnormality in a visual perimetry test
  • Concomitant use of cannabinoids
  • Used benzodiazepines for epilepsy during which the dose has not been stable for >4 weeks prior to Visit 1. Benzodiazepines use as rescue medication for seizure control is allowed; however, intermittent use of benzodiazepines for any other indication (example, anxiety/sleep disorders) is prohibited
  • A VNS implanted <5 months before Visit 1 or changes in parameter <4 weeks before Visit 1 (or thereafter during the study)
  • On a ketogenic diet for which the diet is not a stable regimen for at least 4 weeks before Visit 1
  • History of or a concomitant medical condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study or compromise the participant's ability to safely complete the study
  • Have previously been exposed to perampanel in a clinical trial or by prescription for more than 2 months or discontinued for Adverse Events (AEs)
  • Have participated in a study involving administration of an investigational drug or device within 4 weeks before Visit 1, or within approximately 5 half-lives of the previous investigational compound, whichever is longer
  • Participants with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849626


Locations
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Sponsors and Collaborators
Eisai Inc.
Investigators
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OverallOfficial: Eisai Medical Information Eisai Inc.
  Study Documents (Full-Text)

Documents provided by Eisai Inc.:
Study Protocol  [PDF] July 13, 2018
Statistical Analysis Plan  [PDF] August 2, 2018

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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT02849626    
Other Study ID Numbers: E2007-G000-311
2014-002167-16 ( EudraCT Number )
First Posted: July 29, 2016    Key Record Dates
Results First Posted: April 6, 2020
Last Update Posted: April 21, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eisai Inc.:
Partial-Onset Seizures
Primary Generalized Tonic-Clonic Seizures
Adjunctive Therapy
Epilepsy
Additional relevant MeSH terms:
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Seizures
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms