A double-blind, randomised, placebo-controlled, multi-centre study toassess the efficacy and safety of adjunctive zonisamide in paediatric partial onsetseizures - CATZ
- Conditions
- EpilepsyMedDRA version: 9.1Level: LLTClassification code 10065336Term: Partial epilepsy
- Registration Number
- EUCTR2006-002515-27-FR
- Lead Sponsor
- Eisai Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 207
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
1. Subject of body weight < 20 kg at the Screening Visit.
2. Subject is unable to swallow capsules.
3. Subject has progressive neurological disease (determined by diagnosis or a preexisting
brain image such as a CT scan or MRI).
4. Subject has a history of idiopathic generalised epilepsy as defined by the
International League Against Epilepsy (ILAE).
5. Subjects with Lennox-Gastaut syndrome, absence, myoclonic, clonic and/or tonic
(other than secondary generalised) and atonic seizures.
6. Subject has psychogenic seizures.
7. Subject has a history of status epilepticus within a year of the Screening Visit
whilst taking AEDs.
8. Subject has seizures that only occur in clustered patterns, or has seizures that are
too close together to count accurately.
9. Subject has a history of renal calculi or renal insufficiency (creatinine levels >194
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br>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).
- Secondary Outcome Measures
Name Time Method