Status:
COMPLETED
A Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Extension Study)
Lead Sponsor:
Eisai Limited
Conditions:
Partial Seizures
Eligibility:
All Genders
6-18 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the long-term safety and efficacy of zonisamide used as an adjunctive treatment in pediatric subjects treated with 1 or 2 other anti-epileptic drugs (AEDs).
Detailed Description
Those subjects who completed the double-blind study (E2090-E044-312) will be invited to participate in this extension study. The study consists of two main parts: Transition Period (double-blind) and ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subject has completed the double-blind study E2090-E044-312.
- Parent/caregiver is willing to sign an informed consent where the subject is under the age of consent.
- Subject is male or female aged 6 to 18 years 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.
- Subject is in general good health as determined by medical history, physical exam and screening laboratory results.
- EXCLUSION CRITERIA:
- Subject has a body weight \< 20 kg.
- Subject has developed a history of renal calculi or renal insufficiency (creatinine level \> 135 µmol/l (1.5 mg/dl).
- Subject has a known diagnosis of human immunodeficiency virus (HIV) or hepatitis B or C.
- Subject has a history of sensitivity to sulfonamide drugs or zonisamide and its excipients.
- 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 sterilization, 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 reconsented in order to given consent to undergo pregnancy testing and either confirm abstinence or receive a medically appropriate form of contraception.
- Subject has a recent history of excessive alcohol use or drug abuse.
- Subject has a history of suicide attempt.
- Subject has a clinically significant organic disease.
- 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.
- Frequent need of rescue benzodiazepines (one or more times a month).
- Concomitant use of acetazolamide, carbonic anhydrase inhibitors such as topiramate, furosemide and drugs with anticholinergic activity.
- Concomitant use of felbamate or use of felbamate within 2 months prior to Visit 1 of the E2090-E044-312 study.
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT01136954
Start Date
July 1 2008
End Date
March 1 2012
Last Update
January 25 2016
Active Locations (1)
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1
Firenze, 50132, FI, Italy, 50132