A double-blind, randomised, placebo-controlled, multi-centre study to assess the efficacy and safety of adjunctive zonisamide in paediatric partial onset seizures - ND
- Conditions
- epilepsyMedDRA version: 9.1Level: LLTClassification code 10056209Term: Partial seizures with secondary generalisation
- Registration Number
- EUCTR2006-002515-27-IT
- Lead Sponsor
- EISAI LTD UK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 266
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 generalised seizures according to the International League Against Epilepsy?s Classification of Epileptic Seizures (1981). 5. Diagnosis has 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). 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 pre-existing 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. See Protocol for other exclusion criteria
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method