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 has completed the double-blind study, E2090-E044-312. 2. Parent/caregiver is willing to sign an informed consent where the subject is under the age of consent. 3. Subject is male or female aged 6–18 years inclusive, who is willing to give informed (written or verbal) assent, if applicable. If mandated by local regulations, subjects of relevant age will be required to sign an appropriate informed consent. 4. Subject is in general good health as determined by medical history, physical exam and screening laboratory results. 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 has a body weight 135 µmol/l (1.5 mg/dl). 3. Subject has a known diagnosis of human immunodeficiency virus (HIV) or hepatitis B or C. 4. Subject has a history of sensitivity to sulfonamide drugs or to zonisamide and its excipients. 5. Female subject of 10 years of age 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 injected form of contraception, or intrauterine device), or who is not prepared to abstain from sexual activity for the duration of the study and for one month after the last administration of study medication. NOTE: Should a female subject become of child bearing potential during the study, they must be re-consented in order to undergo pregnancy testing and either confirm abstinence or receive a medically appropriate form of contraception. 6. Subject has a recent history of excessive alcohol use or drug abuse. 7. Subject has a history of suicide attempt. 8. Subject has a clinically significant organic disease. 9. Subject has a history of demonstrated non-compliance with treatment or subject or parent/legal guardian can be reasonably expected not to be compliant with study procedures or to complete the study. 10. Frequent need of rescue benzodiazepines (one or more times a month). 11. Concomitant use of acetazolamide, carbonic anhydrase inhibitors such as topiramate, furosemide and drugs with anticholinergic activity. 12. Concomitant use of felbamate or use of felbamate within 2 months prior to Visit 1 of the E2090-E044-312 study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the long-term safety of zonisamide used as an adjunctive treatment in paediatric subjects treated with one or two other anti-epileptic drugs (AEDs). ;Secondary Objective: To assess long term maintenance of efficacy.;Primary end point(s): The primary efficacy parameter is the proportion of responders. A responder is defined as a subject with a decrease from baseline in seizure frequency of = 50% during the study. | — |
Countries
Belgium, Estonia, France, Hungary, Italy, Latvia, Poland, Spain, United Kingdom
Outcome results
None listed