Pediatric Epileptic SyndromePhase 2NCT04015141
A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy
A Phase 2 study testing Perampanel Oral Suspension and Perampanel Tablet in people with Pediatric Epileptic Syndrome and Partial-onset Seizures, run by Eisai Inc. at 35 sites in 6 countries.
Trial summary
The purpose of the study is to evaluate the efficacy of perampanel as measured by the 50 percent (%) responder rate during the maintenance period of the core study for seizure frequency in participants with pediatric epileptic syndrome (Cohort 1) and partial-onset seizures (POS) (Cohort 2). Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Pediatric Epileptic Syndrome, Partial-onset Seizures
- What is being tested?
- Perampanel Oral Suspension and Perampanel Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 35 sitesin 6 countries
- Study dates
- 31 May 2019to 23 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female participants. Cohort 1: age 1 month to less than 18 years; Cohort 2: age 1 month to less than 2 years at the time of informed consent/assent. Participants below the age of 1 year must have been at least 36 weeks of gestational age at birth.
- Have a diagnosis of epilepsy with a pediatric epileptic syndrome (Cohort 1) or epilepsy with POS with or without secondary generalization (Cohort 2).
- Have had equal or greater than 4 seizures over the 4-week interval prior to enrollment visit.
- Absence of any progressive cause of epilepsy that has been confirmed clinically or based on brain imaging (example, magnetic resonance imaging [MRI] scan or computed tomography [CT] or ultrasound [for less than 1 year old]).
- Currently maintained on stable doses of 1 to a maximum of 4 approved antiepileptic drugs (AEDs). A prescription medical marijuana (including products containing cannabidiol) is counted as 1 of the maximum of 4 allowed AEDs; however, it cannot be the only concomitant AED if this product is not an approved AED in the country where the study site is located. Doses must be stable for at least 4 weeks (at least 2 weeks for participant less than [<] 6 months old) before Visit 1/Baseline or screening; only 1 enzyme-inducing antiepileptic drug (EIAED) (defined as carbamazepine, phenytoin, oxcarbazepine, or eslicarbazepine) out of the maximum of 4 AEDs is allowed.
Who cannot join
- Current or history of pseudo-seizures (psychogenic nonepileptic seizures) within approximately 5 years before screening visit.
- Have a history of status epilepticus that required hospitalization within 6 months before screening visit.
- Have an unstable psychiatric diagnosis that may confound participant's 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 screening visit 1, current psychotic disorder, acute mania).
- Any suicidal ideation with intent with or without a plan within 6 months before enrollment visit (answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the C-SSRS) in participants aged 6 and above or based on the opinion of the Investigator for participants less than 6 years.
- Are scheduled or confirmed or both to have epilepsy surgery within 6 months after screening visit; however, those who have previously documented "failed" epilepsy surgery will be allowed.
- Have a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
Show all 10Show fewer
- Benzodiazepines for any indications other than epilepsy (example, anxiety/sleep disorders) prohibited from 1 month before Visit 1/Baseline or screening and during the study. Benzodiazepines for seizure control and as rescue medication are allowed.
- A vagal nerve stimulator (VNS), responsive neurostimulator (RNS), or deep brain stimulator (DBS) implanted less than 5 months before screening visit or changes in parameter less than 4 weeks before screening visit (or thereafter during the study).
- Use of perampanel within 30 days before screening visit, or perampanel was discontinued due to adverse reactions (perampanel-related) or lack of efficacy in case of previous exposure.
- Weight less than 4.0 kilogram (kg) at Visit 1 (Baseline or screening).
Trial locations and contacts
35 sites in 6 countries.
35 sites in 6 countries
United States15 sites
Childrens Hospital Colorado
Aurora, Colorado, 80045
Child Neurology Consultants of Austin
Austin, Texas, 78731
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Dayton Children's Hospital
Dayton, Ohio, 45404
Children's Hospital of Michigan
Detroit, Michigan, 48201
Northeast Regional Epilepsy Group
Hackensack, New Jersey, 07601
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
Nicklaus Children's Hospital
Miami, Florida, 33155
Children's Specialty Group
Norfolk, Virginia, 23510
Children's Hospital of Richmond at VCU - CHoR-PIN
Richmond, Virginia, 23298
Road Runner Research Ltd
San Antonio, Texas, 78249
Meridian Clinical Research-(Savannah Georgia)
Savannah, Georgia, 31406
Seattle Children's Hospital
Seattle, Washington, 98105
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida, 33607
Wake Forest Baptist Medical Center - PPDS
Winston-Salem, North Carolina, 27157
France6 sites
Hôpital Pellegrin-Enfants
Bordeaux
Hopitaux de La Timone
Marseille, Bouches-du-Rhone
Hopital Necker
Paris
Hopitaux de Paris CHU Hopital Robert Debre - Inserm U676
Paris
CHRU Rennes
Rennes
Centre Hospitalier Universitaire de Toulouse
Toulouse
Spain5 sites
Hospital Clinico San Carlos
Madrid
Hospital General Universitario Gregorio Marañon
Madrid
Complejo Hospitalario de Navarra
Pamplona
CHUS - H. Clinico U. de Santiago
Santiago de Compostela
Hospital Universitario Virgen del Rocio - PPDS
Seville
Belgium4 sites
Hôpital Universitaire des Enfants Reine Fabiola
Brussels, Brussels Capital
UZ Brussel
Brussels, Brussels Capital
UZ Gent
Ghent, Oost-Vlaanderen
Centre Neurologique William Lennox
Ottignies, Brabant Wallon
Germany4 sites
Universitätsklinikum Freiburg
Freiburg im Breisgau
Universitätsklinikum Jena
Jena
Dr. Von Haunersches Kinderspital
Munich
Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh
Radeberg
About this study
Official title: An Open-Label Study With Extension Phase to Evaluate the Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Subjects (Age 1 Month to Less Than 18 Years) With Childhood Epilepsy
The purpose of the study is to evaluate the efficacy of perampanel as measured by the 50 percent (%) responder rate during the maintenance period of the core study for seizure frequency in participants with pediatric epileptic syndrome (Cohort 1) and partial-onset seizures (POS) (Cohort 2).
Read the detailed description
This study will consist of a Core Study, Extension Phase A and Extension Phase B.
- Core Study will consist of the following 2 phases: Pretreatment (4 weeks screening or baseline period) and Treatment Period. The Treatment Period (23 weeks) of Core study include Titration period (10 weeks) and Maintenance period (13 weeks).
- Extension Phase A will consist of a Treatment Period (33 weeks) and a Follow-up Period (4 weeks). All participants who will complete the Core Study will be eligible to participate in Extension Phase A of the study.
- Extension Phase B will only be for participants who reside in countries where perampanel (oral tablets or oral suspension) is not commercially available or an extended access program (EAP) is not yet implemented, participants have completed Extension Phase A, and who, in the opinion of the investigator, will continue to benefit from treatment with perampanel.
- Being tested
- Perampanel Oral Suspension, Perampanel Tablet
- Keywords
- Partial-onset seizures, Pediatric epileptic syndrome, Epilepsy, Childhood epilepsy, Epilepsy in children, Refractory seizures, Inadequately controlled seizures, E2007, Fycompa, Perampanel
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perampanel Oral SuspensionDrug
Also called E2007, Fycompa
Perampanel oral suspension.
Perampanel TabletDrug
Also called E2007, Fycompa
Perampanel tablet.
| Study group | Role | What they receive |
|---|---|---|
| Perampanel | Experimental | Participants aged 1 month to less than 18 years with pediatric epileptic syndrome (Cohort 1) or aged 1 month to less than 2 years with POS (Cohort 2) will receive perampanel oral suspension or perampanel tablets, once daily up to 56 weeks. Receives: Drug: Perampanel Oral Suspension; Drug: Perampanel Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of 50% Responders For All Seizures During the Maintenance Period of Core Study
A response of 50% will be defined as a decrease in 28-day seizure frequency of equal or greater than 50% compared to baseline seizure frequency.
Measured: Week 10 to Week 23
Secondary outcomes (22)
Proportion of 50% Responders During Treatment Period of Core Study and Extension Phase A
A response of 50% is defined as a decrease in 28-day seizure frequency of equal or greater than 50% compared to baseline seizure frequency.
Measured: Treatment Period of Core Study and Extension Phase A: Week 0 to Week 56
Proportion of 25% and 75% Responders for all Seizures, During Maintenance Period of Core Study and During Treatment Period of Core Study and Extension Phase A
A response of 25% is defined as a decrease in 28-day seizure frequency of equal or greater than 25% compared to baseline seizure frequency. 75% response is defined as a decrease in 28-day seizure frequency of equal or greater than 75% compared to baseline seizure frequency.
Measured: Maintenance Period of Core study: Week 10 to Week 23; Treatment Period of Core Study and Extension Phase A: Week 0 to Week 56
Proportion of Participants Who Are Seizure-Free During the Maintenance Period of Core Study and During the Treatment Period of Core Study and Extension Phase A
Measured: Maintenance Period of Core study: Week 10 to Week 23; Treatment Period of Core Study and Extension Phase A: Week 0 to Week 56
Change From Baseline in Seizure Frequency For All Seizures During the Treatment Period of Core Study and During the Treatment Period of Core Study and Extension Phase A
Measured: Baseline, Treatment Period of Core study: Week 23, Treatment Period of Core Study and Extension Phase A: Week 56
Percent Change From Baseline in Seizure Frequency For All Seizures During the Treatment Period of Core Study and During the Treatment Period of Core Study and Extension Phase A
Measured: Baseline, Treatment Period of Core study: Week 23, Treatment Period of Core Study and Extension Phase A: Week 56
Clinical Global Impression of Change (CGIC) at the End of the Treatment Period of Core Study and at the End of Extension Phase A
Assessment of disease severity will utilize the CGIC scale at end of treatment to evaluate participant's change in disease status since initiation of treatment. The CGIC is a 7-point scale that measures a physician's global impression of a participant's clinical condition. Scale ranges from 1 to 7 with lower scores indicating improvement (1=very much improved, 2=much improved, 3=minimally improved), higher scores indicating worsening (5=minimally worse, 6= much worse, 7=very much worse), and a score of 4 indicating no change.
Measured: Treatment Period of Core Study: Week 23, Extension Phase A: Week 56
Subject Global Impression of Change (SGIC) at the End of the Treatment Period of Core Study and at the End of Extension Phase A
SGIC is a 7-Point scale that provides a participant-determined summary measure of change from baseline of participant's status. Scale ranges from 1 to 7 with lower scores indicating improvement (1=very much improved, 2=much improved, 3=minimally improved), higher scores indicating worsening (5=minimally worse, 6= much worse, 7=very much worse), and a score of 4 indicating no change.
Measured: Treatment Period of Core Study: Week 23, Extension Phase A: Week 56
Change From Baseline in the Cognitive Drug Research (CDR) Parameter at the End of the Treatment Period of Core Study and at the End of Extension Phase A
The CDR System Global Cognition Score (cognitive test battery) is derived from 5 CDR System domain scores, also called factor scores: Power of Attention, Continuity of Attention, Quality of Episodic Memory, Quality of Working Memory, and Speed of Memory. The CDR assessment and Child Behavior Checklist (CBCL) will be administered to participants 6 years and over and 2 years and over, respectively, using an age-appropriate version to assess cognitive function and behavior.
Measured: Baseline, Treatment Period of Core Study: Week 23, Extension Phase A: Week 56
Change from Baseline in CBCL Parameters at the End of the Treatment Period of Core Study and at the End of Extension Phase A
The CBCL is a questionnaire to assess behavioral and emotional problems in children as reported by the primary caregiver. It is standardized to evaluate maladaptive behavioral and emotional problems in ages 1.5 to 5 years (CBCL 1.5/5) or 6 to 18 years (CBCL). The CBCL examines three domains (Social Functioning, Mood and Anxiety Symptoms, and Externalizing Symptoms) by assessing 140 problem items that describe specific behavioral and emotional problems. Respondents indicate how accurately the statements describe the child by selecting from options on a 3-point Likert-type scale (0=Not True, 1= Somewhat or Sometimes True, or 2=Very True or Often True).
Measured: Baseline, Treatment Period of Core Study: Week 23, Extension Phase A: Week 56
Change from Baseline in Lafayette Grooved Pegboard Test (LGPT) Parameters at the End of the Treatment Period of Core Study and at the End of Extension Phase A
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) indicates worsening of visuomotor skills.
Measured: Baseline, Treatment Period of Core Study: Week 23, Extension Phase A: Week 56
Change from Baseline in Growth and Development Parameter - Height
Measured: Baseline, Treatment Period of Core Study: Week 23; Extension Phase A: Weeks 28, 40, and 56
Change from Baseline in Growth and Development Parameter - Weight
Measured: Baseline, Treatment Period of Core Study: Weeks 2, 5, 8, 10, 14, 18 and 23; Extension Phase A: Weeks 28, 40, 56, and 60
Change from Baseline in Growth and Development Parameter - Free Triiodothyronine (fT3) and Free Thyroxine (fT4) Levels in Blood
Measured: Baseline, Treatment Period of Core Study: Week 23, Extension Phase A: Week 56
Change from Baseline in Growth and Development Parameter - Thyroid-Stimulating Hormone (TSH) Levels in Blood
Measured: Baseline, Treatment Period of Core Study: Week 23, Extension Phase A: Week 56
Change from Baseline in Growth and Development Parameter - Insulin Like Growth Factors (IGF)-1
Measured: Baseline, Treatment Period of Core Study: Week 23, Extension Phase A: Week 56
Change from Baseline in Growth and Development Parameter- Sexual Maturation Assessed by Tanner Staging
Sexual maturation including pubic hair growth (both sexes), genital (males only) and breast (females only) development of participants will be assessed using Tanner Staging.
Measured: Baseline, Treatment Period of Core Study: Week 23, Extension Phase A: Week 56
Proportion of Participants with any Treatment-Emergent Reports of Suicidal Ideation and Behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) and Intensity of These Behaviors Assessed using C-SSRS Scores
C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS is used to assess whether participant experienced SI (1:wish to be dead; 2:non-specific active suicidal thoughts; 3:active SI with any methods (not plan) without intent to act; 4:active SI with some intent to act, without specific plan; 5:active SI with specific plan and intent) and suicidal behavior (6:actual attempt; 7:interrupted attempt; 8:aborted attempt; 9:preparatory acts or behavior; 10:suicidal behavior). An assessment of SI and behavior using the C-SSRS will be performed throughout the study for participants aged 6 years and above at the time of consent. In participants younger than 6 years, SI and behavior will be monitored based upon clinical impression.
Measured: Treatment period of Core Study: Weeks 0, 2, 5, 8, 10, 14, 18, and 23; Extension Phase A: Weeks 28, 46, 56 and 60
Change from Baseline in Number of Seizures Recorded on Electroencephalogram (EEG) at the End of the Treatment Period of Core Study and at the End of Extension Phase A
Measured: Baseline, End of the Treatment Period of Core Study: Week 23, End of Extension Phase A: Week 56
Number of Participants with at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
Measured: From date of first dose of perampanel up to 28 days after the last dose of perampanel (Week 60)
Number of Participants with Treatment Emergent Markedly Abnormal Laboratory Values
Measured: From date of first dose of perampanel up to Week 60
Number of Participants with Clinically Notable Vital Sign Results
Vital sign measurements include systolic and diastolic blood pressure [millimeters of Mercury (mmHg)], pulse (beats per minute), respiratory rate (per minute), temperature (degree centigrade), and weight (kilogram).
Measured: From date of first dose of perampanel up to 28 days after the last dose of perampanel (Week 60)
Number of Participants with Clinically Significant Abnormal Electrocardiograms
Measured: From date of first dose of perampanel up to Week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start31 May 2019
- Primary completion6 Apr 2027 (estimated)
- Study completion23 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Epileptic SyndromeStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015141
- Sponsor's protocol ID
- E2007-G000-236
- Other IDs
- 2018-004456-38, 2018
- Status last verified
- Jul 2026
- First submitted
- 27 May 2019
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study With Extension Phase to Evaluate the Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Subjects (Age 1 Month to Less Than 18 Years) With Childhood Epilepsy
- ClinicalTrials.gov ID
- NCT04015141
- Acronym / sponsor ID
- E2007-G000-236
- Keywords
- Partial-onset seizures, Pediatric epileptic syndrome, Epilepsy, Childhood epilepsy, Epilepsy in children, Refractory seizures, Inadequately controlled seizures, E2007
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- 31 May 2019 (actual)
- Primary completion
- 6 Apr 2027 (estimated)
- Study completion
- 23 Dec 2027 (estimated)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the efficacy of perampanel as measured by the 50 percent (%) responder rate during the maintenance period of the core study for seizure frequency in participants with pediatric epileptic syndrome (Cohort 1) and partial-onset seizures (POS) (Cohort 2).
Detailed description
This study will consist of a Core Study, Extension Phase A and Extension Phase B.
- Core Study will consist of the following 2 phases: Pretreatment (4 weeks screening or baseline period) and Treatment Period. The Treatment Period (23 weeks) of Core study include Titration period (10 weeks) and Maintenance period (13 weeks).
- Extension Phase A will consist of a Treatment Period (33 weeks) and a Follow-up Period (4 weeks). All participants who will complete the Core Study will be eligible to participate in Extension Phase A of the study.
- Extension Phase B will only be for participants who reside in countries where perampanel (oral tablets or oral suspension) is not commercially available or an extended access program (EAP) is not yet implemented, participants have completed Extension Phase A, and who, in the opinion of the investigator, will continue to benefit from treatment with perampanel.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perampanel | Experimental | Drug: Perampanel Oral Suspension, Drug: Perampanel TabletParticipants aged 1 month to less than 18 years with pediatric epileptic syndrome (Cohort 1) or aged 1 month to less than 2 years with POS (Cohort 2) will receive perampanel oral suspension or perampanel tablets, once daily up to 56 weeks. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Male or female participants. Cohort 1: age 1 month to less than 18 years; Cohort 2: age 1 month to less than 2 years at the time of informed consent/assent. Participants below the age of 1 year must have been at least 36 weeks of gestational age at birth.
- Have a diagnosis of epilepsy with a pediatric epileptic syndrome (Cohort 1) or epilepsy with POS with or without secondary generalization (Cohort 2).
- Have had equal or greater than 4 seizures over the 4-week interval prior to enrollment visit.
- Absence of any progressive cause of epilepsy that has been confirmed clinically or based on brain imaging (example, magnetic resonance imaging [MRI] scan or computed tomography [CT] or ultrasound [for less than 1 year old]).
- Currently maintained on stable doses of 1 to a maximum of 4 approved antiepileptic drugs (AEDs). A prescription medical marijuana (including products containing cannabidiol) is counted as 1 of the maximum of 4 allowed AEDs; however, it cannot be the only concomitant AED if this product is not an approved AED in the country where the study site is located. Doses must be stable for at least 4 weeks (at least 2 weeks for participant less than [<] 6 months old) before Visit 1/Baseline or screening; only 1 enzyme-inducing antiepileptic drug (EIAED) (defined as carbamazepine, phenytoin, oxcarbazepine, or eslicarbazepine) out of the maximum of 4 AEDs is allowed.
Key exclusion criteria (10 listed)
- Current or history of pseudo-seizures (psychogenic nonepileptic seizures) within approximately 5 years before screening visit.
- Have a history of status epilepticus that required hospitalization within 6 months before screening visit.
- Have an unstable psychiatric diagnosis that may confound participant's 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 screening visit 1, current psychotic disorder, acute mania).
- Any suicidal ideation with intent with or without a plan within 6 months before enrollment visit (answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the C-SSRS) in participants aged 6 and above or based on the opinion of the Investigator for participants less than 6 years.
- Are scheduled or confirmed or both to have epilepsy surgery within 6 months after screening visit; however, those who have previously documented "failed" epilepsy surgery will be allowed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perampanel Oral SuspensionAlso: E2007, FycompaPerampanel oral suspension. | Drug | Perampanel |
| Perampanel TabletAlso: E2007, FycompaPerampanel tablet. | Drug | Perampanel |
Primary outcome
Proportion of 50% Responders For All Seizures During the Maintenance Period of Core Study
Time frame: Week 10 to Week 23
A response of 50% will be defined as a decrease in 28-day seizure frequency of equal or greater than 50% compared to baseline seizure frequency.
22 secondary outcomes
Proportion of 50% Responders During Treatment Period of Core Study and Extension Phase A
Time frame: Treatment Period of Core Study and Extension Phase A: Week 0 to Week 56
Proportion of 25% and 75% Responders for all Seizures, During Maintenance Period of Core Study and During Treatment Period of Core Study and Extension Phase A
Time frame: Maintenance Period of Core study: Week 10 to Week 23; Treatment Period of Core Study and Extension Phase A: Week 0 to Week 56
Proportion of Participants Who Are Seizure-Free During the Maintenance Period of Core Study and During the Treatment Period of Core Study and Extension Phase A
Time frame: Maintenance Period of Core study: Week 10 to Week 23; Treatment Period of Core Study and Extension Phase A: Week 0 to Week 56
Change From Baseline in Seizure Frequency For All Seizures During the Treatment Period of Core Study and During the Treatment Period of Core Study and Extension Phase A
Time frame: Baseline, Treatment Period of Core study: Week 23, Treatment Period of Core Study and Extension Phase A: Week 56
Percent Change From Baseline in Seizure Frequency For All Seizures During the Treatment Period of Core Study and During the Treatment Period of Core Study and Extension Phase A
Time frame: Baseline, Treatment Period of Core study: Week 23, Treatment Period of Core Study and Extension Phase A: Week 56
Clinical Global Impression of Change (CGIC) at the End of the Treatment Period of Core Study and at the End of Extension Phase A
Time frame: Treatment Period of Core Study: Week 23, Extension Phase A: Week 56
Subject Global Impression of Change (SGIC) at the End of the Treatment Period of Core Study and at the End of Extension Phase A
Time frame: Treatment Period of Core Study: Week 23, Extension Phase A: Week 56
Change From Baseline in the Cognitive Drug Research (CDR) Parameter at the End of the Treatment Period of Core Study and at the End of Extension Phase A
Time frame: Baseline, Treatment Period of Core Study: Week 23, Extension Phase A: Week 56
Change from Baseline in CBCL Parameters at the End of the Treatment Period of Core Study and at the End of Extension Phase A
Time frame: Baseline, Treatment Period of Core Study: Week 23, Extension Phase A: Week 56
Change from Baseline in Lafayette Grooved Pegboard Test (LGPT) Parameters at the End of the Treatment Period of Core Study and at the End of Extension Phase A
Time frame: Baseline, Treatment Period of Core Study: Week 23, Extension Phase A: Week 56
Change from Baseline in Growth and Development Parameter - Height
Time frame: Baseline, Treatment Period of Core Study: Week 23; Extension Phase A: Weeks 28, 40, and 56
Change from Baseline in Growth and Development Parameter - Weight
Time frame: Baseline, Treatment Period of Core Study: Weeks 2, 5, 8, 10, 14, 18 and 23; Extension Phase A: Weeks 28, 40, 56, and 60
Change from Baseline in Growth and Development Parameter - Free Triiodothyronine (fT3) and Free Thyroxine (fT4) Levels in Blood
Time frame: Baseline, Treatment Period of Core Study: Week 23, Extension Phase A: Week 56
Change from Baseline in Growth and Development Parameter - Thyroid-Stimulating Hormone (TSH) Levels in Blood
Time frame: Baseline, Treatment Period of Core Study: Week 23, Extension Phase A: Week 56
Change from Baseline in Growth and Development Parameter - Insulin Like Growth Factors (IGF)-1
Time frame: Baseline, Treatment Period of Core Study: Week 23, Extension Phase A: Week 56
Change from Baseline in Growth and Development Parameter- Sexual Maturation Assessed by Tanner Staging
Time frame: Baseline, Treatment Period of Core Study: Week 23, Extension Phase A: Week 56
Proportion of Participants with any Treatment-Emergent Reports of Suicidal Ideation and Behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) and Intensity of These Behaviors Assessed using C-SSRS Scores
Time frame: Treatment period of Core Study: Weeks 0, 2, 5, 8, 10, 14, 18, and 23; Extension Phase A: Weeks 28, 46, 56 and 60
Change from Baseline in Number of Seizures Recorded on Electroencephalogram (EEG) at the End of the Treatment Period of Core Study and at the End of Extension Phase A
Time frame: Baseline, End of the Treatment Period of Core Study: Week 23, End of Extension Phase A: Week 56
Number of Participants with at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
Time frame: From date of first dose of perampanel up to 28 days after the last dose of perampanel (Week 60)
Number of Participants with Treatment Emergent Markedly Abnormal Laboratory Values
Time frame: From date of first dose of perampanel up to Week 60
Number of Participants with Clinically Notable Vital Sign Results
Time frame: From date of first dose of perampanel up to 28 days after the last dose of perampanel (Week 60)
Number of Participants with Clinically Significant Abnormal Electrocardiograms
Time frame: From date of first dose of perampanel up to Week 60
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: Yes. Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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Dravet Syndrome
Active, not recruitingPhase 3
A Double-blind Study Evaluating the Efficacy, Safety, and Tolerability of Zorevunersen in Patients With Dravet Syndrome
Dravet Syndrome
RecruitingPhase 1/2
A First-in-human Study of S230815 in Pediatric Participants With KCNT1-related Developmental and Epileptic Encephalopathy
Epileptic Encephalopathy
Active, not recruitingObservational study
ESIS in Pediatric DRE
Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Perampanel Oral Suspension and Perampanel Tablet in people with Pediatric Epileptic Syndrome and Partial-onset Seizures, run by Eisai Inc. at 35 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, France, Spain, Belgium, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of 50% Responders For All Seizures During the Maintenance Period of Core Study (time frame: Week 10 to Week 23). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.