Clinical trial NCT02849626: Perampanel as Adjunctive Therapy in Pediatrics With Partial Onset Seizures or Primary Generalized Tonic Clonic Seizures
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Partial-Onset or Primary Generalized Tonic-Clonic Seizures
Keywords: Partial-Onset Seizures
Primary Generalized Tonic-Clonic Seizures
Adjunctive Therapy
Epilepsy
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2016-07-29
Enrollment: 180
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 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)
measure: Percentage of Participants With Treatment Emergent Markedly Abnormal Laboratory Values for Total Group of Participants- Core Phase and Extension Phase A of This Study
timeFrame: Baseline up to 52 weeks
measure: Percentage of Participants With Abnormal Vital Sign Values for Total Group of Participants- Core Phase and Extension Phase A of This Study
timeFrame: Baseline up to 52 weeks
measure: Percentage of Participants With Markedly Abnormal Electrocardiogram (ECG) Parameters for Total Group of Participants- Core Phase and Extension Phase A of This Study
timeFrame: Baseline up to 52 weeks
Secondary outcomes:
measure: 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)
timeFrame: Baseline, Week 23
measure: 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
timeFrame: Baseline up to 23 weeks
measure: 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
timeFrame: Baseline up to 23 weeks
measure: 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
timeFrame: Baseline up to Week 23
measure: 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
timeFrame: Baseline up to Week 23
measure: 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
timeFrame: Baseline up to Week 23
measure: 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
timeFrame: Baseline up to Week 23
measure: 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 Perampanell
timeFrame: Baseline up to Week 23
measure: 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
timeFrame: Baseline up to Week 23
measure: 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
timeFrame: Baseline up to 23 weeks
measure: 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
timeFrame: Baseline, Week 23, Week 52
measure: 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
timeFrame: Baseline, Week 23, Week 52
measure: 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
timeFrame: Baseline, Week 23, Week 52
measure: 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
timeFrame: Baseline, Week 23, Week 52
measure: 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
timeFrame: Baseline, Week 23, Week 52
measure: 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
timeFrame: Baseline, Week 23, Week 52
measure: 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
timeFrame: Baseline, Week 23, Week 52
measure: 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
timeFrame: Baseline, Week 23, Week 52
measure: 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
timeFrame: Baseline, Week 23, Week 52
measure: 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
timeFrame: Baseline, Week 23, Week 52
measure: 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
timeFrame: Baseline up to 52 weeks
measure: Number of Encephalogram (EEG) Abnormalities During Awake and Sleep State for Total Group of Participant: Core Phase and Extension Phase A of This Study
timeFrame: Baseline up to 52 weeks
measure: 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
timeFrame: Up to 52 weeks
measure: 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
timeFrame: Up to 52 weeks
measure: 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
timeFrame: Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52
measure: Percentage of Participants Based on 25% Responder Rate- Core Phase and Extension Phase A of This Study
timeFrame: Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52
measure: Percentage of Participants Based on 50% Responder Rate- Core Phase and Extension Phase A of This Study
timeFrame: Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52
measure: Percentage of Participants Based on 75% Responder Rate- Core Phase and Extension Phase A of This Study
timeFrame: Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52
measure: Percentage of Participants Who Were Seizure-free- Core Phase and Extension Phase A of This Study
timeFrame: Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52
measure: Percentage of Participants With Clinical Global Impression of Change Scores (CGIC)- Core Phase and Extension Phase A of This Study
timeFrame: Baseline, Week 23, Week 52
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Facility #1
state: Arkansas
city: Palo Alto
country: United States
facility: Facility #1
state: California
city: Aurora
country: United States
facility: Facility #1
state: Colorado
city: Gulf Breeze
country: United States
facility: Facility #1
state: Florida
city: Loxahatchee Groves
country: United States
facility: Facility #1
state: Florida
city: Orlando
country: United States
facility: Facility #1
state: Florida
city: Atlanta
country: United States
facility: Facility #1
state: Georgia
city: Savannah
country: United States
facility: Facility #1
state: Georgia
city: Boise
country: United States
facility: Facility #1
state: Idaho
city: Chicago
country: United States
facility: Facility #1
state: Illinois
city: Urbana
country: United States
facility: Facility #1
state: Illinois
city: Ames
country: United States
facility: Facility #1
state: Iowa
city: Wichita
country: United States
facility: Facility #1
state: Kansas
city: Lexington
country: United States
facility: Facility #1
state: Kentucky
city: Lexington
country: United States
facility: Facility #2
state: Kentucky
city: New Orleans
country: United States
facility: Facility #1
state: Louisiana
city: Duluth
country: United States
facility: Facility #1
state: Minnesota
city: Kansas City
country: United States
facility: Facility #1
state: Missouri
city: Henderson
country: United States
facility: Facility #1
state: Nevada
city: Hackensack
country: United States
facility: Facility #1
state: New Jersey
city: Voorhees
country: United States
facility: Facility #1
state: New Jersey
city: Brooklyn
country: United States
facility: Facility #1
state: New York
city: Winston-Salem
country: United States
facility: Facility #1
state: North Carolina
city: Cleveland
country: United States
facility: Facility #1
state: Ohio
city: Memphis
country: United States
facility: Facility #1
state: Tennessee
city: Austin
country: United States
facility: Facility #1
state: Texas
city: San Antonio
country: United States
facility: Facility #1
state: Texas
city: Tacoma
country: United States
facility: Facility #1
state: Washington
city: Milwaukee
country: United States
facility: Facility #1
state: Wisconsin
city: Pulderbos
country: Belgium
facility: Facility #1
state: Antwerpen
city: Ottignies
country: Belgium
facility: Facility #1
state: Brabant Wallon
city: Bruxelles
country: Belgium
facility: Facility #1
state: Brussels
city: La Louviere
country: Belgium
facility: Facility #1
state: Hainaut
city: Brussels
country: Belgium
facility: Facility #1
city: Calgary
country: Canada
facility: Facility #1
state: Alberta
city: Montreal
country: Canada
facility: Facility #1
state: Quebec
city: Ostrava
country: Czechia
facility: Facility #1
city: Praha 4
country: Czechia
facility: Facility #1
city: Marseille
country: France
facility: Facility #1
state: Bouches-du-Rhone
city: Lille Cedex
country: France
facility: Facility #1
city: Marseille
country: France
facility: Facility #1
city: Paris
country: France
facility: Facility #1
city: Paris
country: France
facility: Facility #2
city: Strasbourg
country: France
facility: Facility #1
city: Toulouse Cedex 9
country: France
facility: Facility #1
city: Budapest
country: Hungary
facility: Facility #1
city: Budapest
country: Hungary
facility: Facility #2
city: Miskolc
country: Hungary
facility: Facility #1
city: Pecs
country: Hungary
facility: Facility #1
city: Mantova
country: Italy
facility: Facility #1
state: Lombardia
city: Calambrone
country: Italy
facility: Facility #1
state: Toscana
city: Bologna
country: Italy
facility: Facility #1
city: Firenze
country: Italy
facility: Facility #1
city: Milano
country: Italy
facility: Facility #1
city: Sapporo
country: Japan
facility: Eisai Trial Site #1
state: Hokkaido
city: Zentsuji
country: Japan
facility: Eisai Trial Site #1
state: Kagawa
city: Sendai-shi
country: Japan
facility: Eisai Trial Site #1
state: Miyagi
city: Hamamatsu
country: Japan
facility: Eisai Trial Site #1
state: Sizuoka
city: Fukuoka-shi
country: Japan
facility: Eisai Trial Site #1
city: Fukuoka
country: Japan
facility: Eisai Trial Site #1
city: Gifu
country: Japan
facility: Eisai Trial Site #1
city: Hakodate-shi
country: Japan
facility: Eisai Trial Site #1
city: Hiroshima
country: Japan
facility: Eisai Trial Site #1
city: Izumi
country: Japan
facility: Eisai Trial Site #1
city: Kobe
country: Japan
facility: Eisai Trial Site #1
city: Kumamoto
country: Japan
facility: Eisai Trial Site #1
city: Nagoya
country: Japan
facility: Eisai Trial Site #1
city: Nara
country: Japan
facility: Eisai Trial Site #1
city: Niigata
country: Japan
facility: Eisai Trial Site #1
city: Okayama
country: Japan
facility: Eisai Trial Site #1
city: Omura
country: Japan
facility: Eisai Trial Site #1
city: Osaka
country: Japan
facility: Eisai Trial Site #1
city: Sagamihara
country: Japan
facility: Eisai Trial Site #1
city: Sapporo
country: Japan
facility: Eisai Trial Site #1
city: Shizuoka
country: Japan
facility: Eisai Trial Site #1
city: Yamagata
country: Japan
facility: Eisai Trial Site #1
city: Yokohama-shi
country: Japan
facility: Eisai Trial Site #1
city: Daegu
country: Korea, Republic of
facility: Facility #1
city: Daejeon
country: Korea, Republic of
facility: Facility #1
city: Seoul
country: Korea, Republic of
facility: Facility #1
city: Seoul
country: Korea, Republic of
facility: Facility #2
city: Seoul
country: Korea, Republic of
facility: Facility #3
city: Riga
country: Latvia
facility: Facility #1
city: Gdansk
country: Poland
facility: Facility #1
state: Pomorskie
city: Kielce
country: Poland
facility: Facility #1
state: Swietokrzyskie
city: Poznan
country: Poland
facility: Facility #1
state: Wielkopolskie
city: Esplugues de Llobregat
country: Spain
facility: Facility #1
state: Barcelona
city: Barcelona
country: Spain
facility: Facility #1
city: Barcelona
country: Spain
facility: Facility #2
city: Madrid
country: Spain
facility: Facility #1
city: Sevilla
country: Spain
facility: Facility #1
city: Valencia
country: Spain
facility: Facility #1
Study officials:
affiliation: Eisai Inc.
name: Eisai Medical Information
References:
citation: Trigg A, Brohan E, Cocks K, Jones A, Tahami Monfared AA, Chabot I, Meier G, Campbell R, Li H, Ngo LY. Health-related quality of life in pediatric patients with partial onset seizures or primary generalized tonic-clonic seizures receiving adjunctive perampanel. Epilepsy Behav. 2021 May;118:107938. doi: 10.1016/j.yebeh.2021.107938. Epub 2021 Apr 8.
citation: Fogarasi A, Flamini R, Milh M, Phillips S, Yoshitomi S, Patten A, Takase T, Laurenza A, Ngo LY. Open-label study to investigate the safety and efficacy of adjunctive perampanel in pediatric patients (4 to <12 years) with inadequately controlled focal seizures or generalized tonic-clonic seizures. Epilepsia. 2020 Jan;61(1):125-137. doi: 10.1111/epi.16413. Epub 2020 Jan 7.