Epilepsy MedDRA version: 9.1 Level: LLT Classification code 10065336 Term: Partial epilepsy
Conditions
Sponsors
Eisai Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is male or female aged 6–17 years inclusive. 2. Parent/guardian is willing to sign an approved informed consent form, and accompany the subject on all study visits. 3. Subject is willing to give informed (written or verbal) assent and if appropriate written informed consent. 4. Subject has a clinical diagnosis of epilepsy with partial-onset seizures with or without secondary generalized seizures according to the International League Against Epilepsy’s Classification of Epileptic Seizures (1981). 5. Diagnosis should have been established by clinical history, electroencephalogram (EEG) and computed tomography/ magnetic resonance imaging (CT/MRI) of the brain consistent with localisation related epilepsy. 6. Subject has = four (simple or complex) partial seizures (with or without secondary generalisation) per month over the eight week Screening Period with at least one seizure in each four week period and with no 21 day period being seizure free. 7. Subject is taking a stable regimen of one or two other AEDs for at least one month prior to Visit 1 (start of the Screening Period). NOTE: If using a vagal nerve stimulator (VNS), it must have been implanted for at least five months and stimulator parameters must remain unchanged for at least one month prior to Visit 1 (start of the Screening Period), and throughout the entire study period. VNS will be considered as one AED for the purposes of this study. 8. Subject is in general good health as determined by medical history, physical exam and screening laboratory results. 9. Parent/guardian is willing and able to complete a seizure diary for the duration of the study. Are the trial subjects under 18? yes Number of subjects for this age range: 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. Subject of body weight 135 µmol/l (1.5mg1/dl). 10. Subject had a predisposing condition that might interfere with absorption, distribution, or excretion of zonisamide. 11. Subject has a history of psychiatric illness. 12. Subject has a history of suicide attempt. 13. Female subject who is pregnant or lactating. 14. Subject has a history of demonstrated non-compliance with treatment or, the subject, parent or legal guardian can be reasonably expected not to be compliant with study procedures or to complete the study. 15. Female subject of 10 years or greater or of child bearing potential (i.e. started menses) and is not taking or prepared to take a medically acceptable form of contraception (i.e. oral contraceptive pill, surgical sterilisation, an implant or an injected form of contraception or intrauterine device), or who is not prepared to abstain from sexual activity for the duration of the study and one month after last administration of study medication. NOTE: Should a female subject become of childbearing potential during the study, they must be reconsented, in order to give consent to undergo pregnancy testing and either confirm abstinence or receive medically appropriate form of contraception. 16. Subject has clinically significant abnormal laboratory values at the Screening Visit 17. Subject has a history of demonstrated non-compliance with treatment or, the subject, parent or legal guardian can be reasonably expected not to be compliant with study procedures or to complete the study. 18. Subject has received previous treatment with zonisamide. 19. Subject is treated with a ketogenic diet or is likely to have surgery for epilepsy in the trial period. 20. Subject requires frequent rescue benzodiazepines (one or more times a month). 21. Concomitant use of felbamate or use of felbamate within 2 months prior to Visit 1. 22. Subject has elevations of liver enzymes, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN). 23. Subject has evidence of significant active and unstable haematological disease; i.e. white blood cell (WBC) count < 2500/µL or an absolute neutrophil count < 1000/µL. 24. Subject with clinically significant active hepatic disease, cardiovascular, metabolic, respiratory, renal, endocrinological, any other clinically significant organic diseases and gastrointestinal diseases within 30 days prior to the Screening Visit. 25. Subjects with known or suspected history of alcoholism or drug abuse within the previous two years, or a positive finding on urinary drug screening of any drugs other than prescribed medications. 26. Subjects with any other condition t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of zonisamide in paediatric epilepsy subjects with partial onset seizures treated with one or two other AEDs.;Secondary Objective: To further explore the efficacy and safety of zonisamide. To explore the effect of zonisamide on cognition, and growth and development.;Primary end point(s): The proportion of responders in the Maintenance Period. A responder is defined as a subject with a decrease from baseline in seizure frequency of >50%. The primary analysis will assess the proportion of responders in the stable dose period (i.e. 28 day seizure frequency in the Week 8 to 20 compared to Week -8 to 0). | — |
Countries
Belgium, Estonia, France, Hungary, Italy, Latvia, Poland, Spain, United Kingdom
Outcome results
None listed