A Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Extension Study)
- Conditions
- Health Condition 1: null- Partial Seizures
- Registration Number
- CTRI/2010/091/000641
- Lead Sponsor
- Eisai Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 204
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.
1.Subject has a body weight < 20 kg.
2.Subject has developed a history of renal calculi or renal insufficiency (creatinine level > 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 1 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 (> once a week).
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 3 months prior to Visit 1 in the E2090-E044-312 study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to assess the long-term safety of zonisamide in pediatric subjects treated with one or two other anti-epileptic drugs (AEDs).Timepoint: Time Frame: 59 weeks
- Secondary Outcome Measures
Name Time Method Efficacy endpoints to assess long term maintenance of efficacy will be investigated.Timepoint: Time Frame: 59 weeks