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Sponsored by: |
Eisai Limited |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00566254 |
This will be a double-blind, randomised, study comparing zonisamide with placebo: each arm will consist of 133 subjects. Zonisamide/placebo dosing will commence with a dose of 1 mg/kg. Further dose increases will occur at weekly intervals until a dose of 8 mg/kg is reached at the end of Week 8. In the event of dose limiting adverse events (AEs), during the eight week Titration Period, one down titration to a lower dose is permitted, this can happen at any point in the Titration Period. Subjects who require further down titration steps will be withdrawn from the study. During the Maintenance Period the dose of study medication must remain unchanged.
Changes in concomitant AEDs are not permitted during the Screening, Titration or Maintenance Periods.
This trial consists of the following periods:
Following the Maintenance Period subjects will have the opportunity to enter an open label extension study. This open label extension study will be the subject of a separate protocol and will not be discussed further at this time.
Condition | Intervention | Phase |
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Epilepsy; Paediatric Partial Onset Seizures |
Drug: Zonisamide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Randomised, Placebo-Controlled, Multi-Centre Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures |
Estimated Enrollment: | 266 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | March 2010 |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator |
Drug: Zonisamide
8mg/kg per day for approximately 24 weeks.
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Ages Eligible for Study: | 6 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
Exclusion Criteria:
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 sterlisation, 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.
Contact: Medical Information Department - Eisai Limited | +44 (0)20 8600 1400 |
Study Director: | Rob van Maanen, M.D., MFPM | Eisai Limited |
Study ID Numbers: | E2090-E044-312, 2006-002515-27 |
Study First Received: | November 29, 2007 |
Last Updated: | November 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00566254 |
Health Authority: | European Union: European Medicines Agency |
Signs and Symptoms Epilepsy Zonisamide Seizures |
Neurologic Manifestations Central Nervous System Diseases Brain Diseases |
Antioxidants Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases |
Central Nervous System Agents Protective Agents Anticonvulsants Pharmacologic Actions |