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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004456-38 | EudraCT Number |
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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).
This study will consist of a Core Study, Extension Phase A and Extension Phase B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perampanel Oral Suspension | Drug | Perampanel oral suspension. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 10 to Week 23 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| David Geffen School of Medicine at UCLA | Los Angeles | California | 90095 | United States | ||
| Childrens Hospital Colorado |
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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| Perampanel Tablet | Drug | Perampanel tablet. |
|
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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. |
| 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 | 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 | 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 | 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. | 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. | 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. | 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). | 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. | Baseline, Treatment Period of Core Study: Week 23, Extension Phase A: Week 56 |
| Change from Baseline in Growth and Development Parameter - Height | 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 | 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 | 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 | 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 | 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. | 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. | 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 | 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) | 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 | 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). | 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 | From date of first dose of perampanel up to Week 60 |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Nicklaus Children's Hospital | Miami | Florida | 33155 | United States |
| Pediatric Epilepsy and Neurology Specialists | Tampa | Florida | 33607 | United States |
| Meridian Clinical Research-(Savannah Georgia) | Savannah | Georgia | 31406 | United States |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | United States |
| Northeast Regional Epilepsy Group | Hackensack | New Jersey | 07601 | United States |
| Wake Forest Baptist Medical Center - PPDS | Winston-Salem | North Carolina | 27157 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Dayton Children's Hospital | Dayton | Ohio | 45404 | United States |
| Child Neurology Consultants of Austin | Austin | Texas | 78731 | United States |
| Road Runner Research Ltd | San Antonio | Texas | 78249 | United States |
| Children's Specialty Group | Norfolk | Virginia | 23510 | United States |
| Children's Hospital of Richmond at VCU - CHoR-PIN | Richmond | Virginia | 23298 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Centre Neurologique William Lennox | Ottignies | Brabant Wallon | Belgium |
| Hôpital Universitaire des Enfants Reine Fabiola | Brussels | Brussels Capital | Belgium |
| UZ Brussel | Brussels | Brussels Capital | Belgium |
| UZ Gent | Ghent | Oost-Vlaanderen | Belgium |
| Fakultni nemocnice Brno | Brno | Czechia |
| Hopitaux de La Timone | Marseille | Bouches-du-Rhone | France |
| Hôpital Pellegrin-Enfants | Bordeaux | France |
| Hopital Necker | Paris | France |
| Hopitaux de Paris CHU Hopital Robert Debre - Inserm U676 | Paris | France |
| CHRU Rennes | Rennes | France |
| Centre Hospitalier Universitaire de Toulouse | Toulouse | France |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | Germany |
| Universitätsklinikum Jena | Jena | Germany |
| Dr. Von Haunersches Kinderspital | Munich | Germany |
| Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh | Radeberg | Germany |
| Hospital Clinico San Carlos | Madrid | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | Spain |
| Complejo Hospitalario de Navarra | Pamplona | Spain |
| CHUS - H. Clinico U. de Santiago | Santiago de Compostela | Spain |
| Hospital Universitario Virgen del Rocio - PPDS | Seville | Spain |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C551441 | perampanel |
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