This study is to investigate the pharmacokinetics (PK) of perampanel in pediatric subjects from age =1 month to <4 years.
Conditions
Interventions
Product Name: perampanel
Product Code: E2007
Pharmaceutical Form: Oral suspension
INN or Proposed INN: perampanel
CAS Number: 380917-97-5
Current Sponsor code: E2007
Other descriptive name: PERAMPANEL
Sponsors
Eisai Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, from =1 month to 6 months of age) before Visit 1, by clinical history and an electroencephalogram (EEG) that is consistent with epilepsy; normal interictal EEGs will be allowed provided that the subject meets the other diagnosis criterion (ie, clinical history) 4. Have had brain imaging (computed tomography [CT] or magnetic resonance imaging [MRI]) before Visit 1 that ruled out a progressive cause of epilepsy 5. Have had 1 or more seizure(s) before Visit 1 6. Are currently being treated with a stable dose (ie, unchanged for at least 5 half-lives) of 1 to a maximum of 3 AEDs (At least 6, but not more than 8 subjects will be taking 1 EIAEDs [ie, CBZ, OXC, PHT, or ESL] out of the maximum of 3 AEDs allowed. The remaining subjects cannot be taking any EIAEDs) 7. Have been on their current concomitant AED(s) with a stable dose for at least 2 weeks or 5 half-lives, whichever is longer, before Visit 1 8. Must have discontinued all restricted medications at least 2 weeks or 5 half-lives (whichever is longer) before Visit 1 Are the trial subjects under 18? yes Number of subjects for this age range: 17 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Have a history of status epilepticus that required hospitalization during the 3 months before Visit 1 2. Have seizures due to treatable medical conditions, such as those arising due to metabolic disturbances, toxic exposure, or an active infection 3. Have epilepsy secondary to progressive central nervous system (CNS) disease or any other progressive neurodegenerative disease, including tumors 4. Have had epilepsy surgery within 1 year of Visit 1 5. Are scheduled and/or confirmed to have epilepsy surgery within 6 months after Visit 1 6. Used intermittent rescue benzodiazepines (ie, 1 to 2 doses over a 24-hour period considered one-time rescue) 2 or more times in the 2 weeks before Visit 1 7. Prior use of felbamate 8. Prior use of vigabatrin 9. Are on a ketogenic diet that has not been stable for at least 4 weeks before Visit 1 10. Have used other drugs known to influence the CNS, where the dose has not been stabilized for at least 2 weeks (=6 months of age) or 4 weeks (>6 months of age) before Visit 1 11. Have any concomitant illnesses/co-morbidities that could severely affect the subject’s safety or study conduct 12. Have evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the subject’s safety or study conduct 13. Have clinically significant laboratory abnormalities or any clinically acute or chronic disease 14. Have 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 limits of normal (ULN) 15. Have clinical evidence of significant active hematological disease; white blood cell (WBC) count =2500/µL (2.50 x 10^9/L) or an absolute neutrophil count =1000/µL (1.00 x 10^9/L) 16. Have conditions that may interfere with their participation in the study and/or with the PK of study drug 17. 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 18. Have previously participated in a clinical trial involving perampanel 19. Have a clinically significant electrocardiogram (ECG) abnormality, including prolonged corrected QT interval (QTc) defined as > 450 msec 20. Have had multiple drug allergies or a severe drug reaction to an AE(s), including dermatological (eg, Stevens-Johnson syndrome), hematological, or organ toxicity reactions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the PK of perampanel during the Maintenance Period of the Core Study following oral suspension administration given as an adjunctive therapy in pediatric subjects from 1 month to less than 4 years of age with epilepsy.;Secondary Objective: - To evaluate the short- and long-term safety and tolerability of perampanel oral suspension given as an adjunctive therapy in subjects from 1 month to less than 4 years of age with epilepsy - To evaluate the long-term effect of perampanel oral suspension, given as an adjunctive therapy, on growth from baseline to end of treatment in pediatric subjects from 1 month to less than 4 years of age of age with epilepsy;Primary end point(s): The primary endpoint of this study will be a PK analysis of perampanel following oral suspension administration in pediatric subjects from 1 month to less than 4 years of age with epilepsy, using a population PK approach.;Timepoint(s) of evaluation of this end point: Blood samples (1.0 mL) for PK will be collected from all subjects for determination of perampanel concentrations during Visits 5 (Week 8), 7 (Week 14), and 8 (Week 16) for non EIAED subjects and at Visits 6 (Week 12), 8 (Week 18) and 9 (Week 20) for EIAED subjects, as well as at discontinuation. After every 4th subject completes the Maintenance Period where dose normalized exposure will be compared to that observed in other studies in subjects between =2 and <18 years of age for evidence of systematic deviations potentially warranting dose adjustment in this age group or for other subjects enrolled in the study. All PK data will be analyzed when all subjects have completed the Maintenance Period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are safety endpoints and include: frequency of treatment-emergent adverse events (TEAEs), clinical laboratory parameters, vital signs, ECG results, and growth parameters (height, weight, head circumference, thyroid function and IGF-1 parameters);Timepoint(s) of evaluation of this end point: All data from the Pretreatment and Treatment Phases (Core Study) will be analyzed when all subjects have completed the Maintenance Period. In addition, data from the Pretreatment, Treatment, and Extension Phases will be analyzed when all subjects have completed the Extension Phase. | — |
Countries
Czechia, Latvia, United States
Contacts
Public ContactMedical Information
Eisai Europe Ltd.
Outcome results
None listed