The study being done to see if the Study Drug is safe, tolerable, and can help control seizure in children with epilepsy who are aged 4 to less than 12 years of age and who are already taking seizure medications. The study will also look at pharmacokinetics, which is used to find out the concentration of perampanel in your child’s blood over a period of time.

Phase 1

• Conditions: Epilepsy :1) Partial-Onset Seizures (POS)2) Primary Generalized Tonic-Clonic Seizures (PGTC); MedDRA version: 19.0Level: HLTClassification code 10018101Term: Generalised tonic-clonic seizuresSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 19.0Level: PTClassification code 10061334Term: Partial seizuresSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-002167-16-LV
• Lead Sponsor: Eisai Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-21
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Have a diagnosis of epilepsy with POS with or without secondarily generalized seizures or PGTC according to the International League Against Epilepsy’s (ILAE) Classification of Epileptic Seizures (1981). Diagnosis should have been established at least 6 months prior to Visit 1 by clinical history and an EEG that is consistent with the diagnosis; normal interictal EEGs will be allowed provided that the subject meets the other diagnosis criterion (ie, clinical history)
2. Male or female subject, from age 4 to less than 12 years at the time of informed consent/assent
3. Have a minimum weight of 16 kg (35 lb)
4. Have had a brain imaging (eg, magnetic resonance imaging [MRI] scan or computed tomography[CT]) before Visit 1 that ruled out a progressive cause of epilepsy
5. During the 4 weeks ± 3 days before Visit 2, subjects must have had equal or greater than 1 POS or 1 PGTC seizure. Only simple POS with motor signs, complex POS, and complex POS with secondary generalization are counted toward this inclusion for POS.
6. Are currently being treated with stable doses of 1 to a maximum of 2 approved AEDs. Doses must be stable for at least 4 weeks before to Visit 1; in the case where a new AED regimen has been initiated for a subject, the dose must be stable for at least 8 weeks prior to Visit 1. Only 1 EIAED (defined as carbamazepine, phenytoin, oxcarbazepine, or eslicarbazepine) out of the maximum of 2 AEDs is allowed (A vagal nerve stimulator [VNS] will be counted as one of the 2 allowed AEDs).
Are the trial subjects under 18? yes
Number of subjects for this age range: 160
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

1. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive [ß-hCG] or [hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of ß-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained >72 hours before the 1st dose of study drug.
2. Females of childbearing potential who:
• Had unprotected sexual intercourse within 30 days before study entry & who do not agree to use a highly effective method of contraception ( total abstinence, an intrauterine device, a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period or for 28 days after study drug discontinuation. If a highly effective method is not appropriate or acceptable for the subject, then the subject may use a medically effective method (a double barrier method such as condom plus diaphragm with spermicide).
• Are currently abstinent & do not agree to use a double-barrier method (as above) or refrain from sexually active during the study period or for 28 days after study drug discontinuation.
• Are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing & who do not agree to use the same contraceptive during the study or for 28 days after study drug discontinuation.
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 the study or that may prevent completion of the protocol specified tests (significant suicide risk, including suicidal behavior & ideation within 6 months before Visit 1, current psychotic disorder, acute mania).
6. Any suicidal ideation with intent with or without a plan within 6 months before Visit 2 (ie answering Yes” to questions 4 or 5 on the Suicidal Ideation section of the C-SSRS) in subjects aged > 6 years.
7. Are scheduled and/or confirmed to have epilepsy surgery within 6 months after Visit 1; however, those who have previously documented failed” epilepsy surgery will be allowed.
8. Evidence of clinically significant disease (cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigators could affect the subject’s safety or interfere with the study assessments.
9. Severe renal insufficiency
10. Evidence of significant active hepatic disease. Stable elevation of liver enzymes, ALT & AST due to concomitant medication(s), will be allowed if they are less than 3 times the ULN.
11. Evidence of significant active hematological disease;WBC count = 2500/µL (2.50 1E+09/L) or an absolute neutrophil count = 1000/µL (1.00 1E+09/L).
12. Clinically significant ECG abnormality, including prolonged corrected QT interval defined as > 450 msec.
13. Have a progressive central nervous system disease, including degenerative CNS diseases & progressive tumors.
14. Multiple drug allergies or a severe drug reaction to an AEDs, including dermatological (Stevens-Johnson syndrome) haematological or organ toxicity.
15. Concomitant use of felbamate as an AED for < 2 years or where the dose has not been stable for at least 8 weeks before Visit 1. They must not have a history of WBC count below = 2500/µL (2.50 1E+09/L), pl

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified