A study done to determine the concentration of the investigational drug, perampanel (E2007) (called, Study Drug) in the child's blood over a period of time.
- Conditions
- Therapeutic area: Diseases [C] - Nervous System Diseases [C10]This study is to investigate the pharmacokinetics (PK) of perampanel in pediatric subjects from age =1 month to <4 years.
- Registration Number
- EUCTR2013-005391-17-LV
- Lead Sponsor
- Eisai Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 17
1. Male or female, from =1 month to < 4 years) of age (and of at least 36 weeks gestational age) at the time of consent
2. Have a minimum weight of 4 kg (8.8 lb)
3. Have a diagnosis of epilepsy with any type of seizure according to the ILAE guidelines: International League Against Epilepsy’s Classification of Epileptic Seizures (1981). Diagnosis should have been established at least 2 weeks (=6 months of age) or 4 weeks (>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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method