A study to evaluate efficacy and safety of perampanel when administered together with other current antiepileptic medications in children with epilepsy

Phase 1

• Conditions: Seizures associated with paediatric epilepsy syndromes and partial-onset seizures; MedDRA version: 21.0Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-004456-38-DE
• Lead Sponsor: Eisai Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-11
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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. Absence of any progressive cause of epilepsy that has been confirmed clinically or based on brain imaging.
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 <6 months old) before Visit 1; only 1 EIAED out of the maximum of 4 AEDs is allowed.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
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

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. Benzodiazepines for
seizure control and as rescue medication are allowed.
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
25. Weight less than 4.0 kg.

Study & Design

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