Seizures associated with paediatric epilepsy syndromes and partial-onset seizures MedDRA version: 21.0 Level: PT Classification code 10015037 Term: Epilepsy System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
Eisai Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be included in this study: 1. Male or female subject, from age 1 month to less than 18 years. 2. Have a diagnosis of epilepsy with a pediatric epileptic syndrome or epilepsy with POS with or without secondary generalization. 3. Subjects must have had equal or greater than 4 seizures over the 4-week interval prior to Visit 2. 4. Have had brain imaging before Visit 1 that ruled out a progressive cause of epilepsy. 5. Are currently being treated with stable doses of 1 to a maximum of 4 approved AEDs. Doses must be stable for at least 4 weeks (at least 2 weeks for subjects =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be excluded from this study: 1. Females who are breastfeeding or pregnant at Screening or Baseline. 2. Females of childbearing potential who: ? Within 28 days before study entry, did not use a combination of a barrier method with a highly effective method of contraception. ? Do not agree to use a combination of a barrier method with a highly effective method of contraception. 3. Current or history of pseudo-seizures (psychogenic nonepileptic seizures) within approximately 5 years before Visit 1. 4. Have a history of status epilepticus that required hospitalization during the 6 months before to Visit 1. 5. Have an unstable psychiatric diagnosis that may confound subjects’ ability to participate in the study or that may prevent completion of the protocol specified tests. 6. Any suicidal ideation with intent with or without a plan within 6 months before Visit 2. 7. Are scheduled or confirmed or both to have epilepsy surgery within 6 months after Visit 1. 8. Evidence of clinically significant disease that in the opinion of the investigator could affect the subject’s safety or interfere with the study assessments. 9. Evidence of moderate or severe renal insufficiency as defined by estimated glomerular filtration rates (eGFRs). 10. Evidence of significant active hepatic disease. 11. Evidence of significant active hematological disease. 12. Clinically significant ECG abnormality, including Fridericia prolonged corrected QT interval (QTcF) defined as greater than 450 msec. 13. Have a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors. 14. Multiple drug allergies or a severe drug reaction to AEDs, including dermatological (eg, Stevens-Johnson syndrome), hematological, or organ toxicity reactions. 15. Concomitant use of felbamate as an AED for less than 2 years or where the dose has not been stable for at least 8 weeks before Visit 1. 16. Concomitant or recent (within last 5 months before Visit 1) use of vigabatrin or any evidence of vigabatrin-associated clinically significant vision abnormality. 17. Benzodiazepines for any indications other than epilepsy prohibited from 1 month before Visit 1 and during the study. 18. A vagal nerve stimulator (VNS), responsive neurostimulator (RNS), or deep brain stimulator (DBS) implanted less than 5 months before Visit 1 or changes in parameter less than 4 weeks before Visit 1 (or thereafter during the study). 19. On a ketogenic diet for which the diet is not stable regimen for at least 4 weeks before to Visit 1. 20. History of or a concomitant medical condition that in the opinion of the investigator would preclude the subject’s participation in a clinical study or compromise the subject’s ability to safely complete the study. 21. Use of perampanel within 30 days before Visit 1, or perampanel was discontinued due to adverse reactions (perampanel-related) or lack of efficacy in case of previous exposure. 22. Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. 23. Have participated in a study involving administration of an investigational drug or device within 4 weeks before Visit 1. 24. Hypersensitivity to the active substance or to any of the excipients of the study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of perampanel as measured by the 50% responder rate.;Secondary Objective: 1. To evaluate the efficacy of perampanel as measured by the proportion of subjects who are seizure-free. 2. To evaluate the efficacy of perampanel as measured by absolute reduction and percentage of reduction in seizure frequency per 28 days. 3. To evaluate the effects of perampanel on the Clinical Global Impression (CGI). 4. To evaluate the effects of perampanel on the Subject Global Impression (SGI). 5. To evaluate the effects of perampanel on cognition, behavior, and growth and development. 6. To evaluate the efficacy of perampanel as measured by the proportion of responders. 7. To evaluate the efficacy of perampanel as measured by responder rate. 8. To characterize the PK of perampanel and explore exposure/response relationship. 9. To evaluate the safety and tolerability of perampanel.;Primary end point(s): Proportion of 50% responders for all seizures.;Timepoint(s) of evaluation of this end point: 23 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of subjects who are seizure-free. 2. Absolute and Percent Change from baseline in seizure frequency for all seizures. 3. CGI of Change. 4. SGI of Change. 5. Change from baseline in CDR. 6. Change from baseline in CBCL. 7. Proportion of responders for all seizures. 8. Changes from baseline in growth and development parameters. 9. Proportion of subjects with any treatment-emergent reports of suicidal ideation and behavior on the C-SSRS and intensity of these behaviors assessed using C-SSRS scores. 10. Change from baseline in number of seizures recorded on EEG. 11. Safety and tolerability;Timepoint(s) of evaluation of this end point: 1. 23 & 52 weeks 2. 23 & 52 weeks 3. 23 & 52 weeks 4. 23 & 52 weeks 5. 23 & 52 weeks 6, 23 & 52 weeks 7. 23 & 52 weeks 8. Continuous 9. 23 & 52 weeks 10. 23 & 52 weeks 11. Continuous | — |
Countries
Belgium, Czechia, Czech Republic, Denmark, France, Germany, Spain, United States
Contacts
Public ContactMedical Information
Eisai Europe Ltd.
Outcome results
None listed