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| Sponsor: | Eisai Inc. |
|---|---|
| Information provided by: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT00477295 |
Purpose
This is a two-arm, randomized, double-blind, non-inferiority study using a flexible dosing regime to allow optimal zonisamide or carbamazepine therapy for individual subjects. Assessment of eligibility will take place at the Screening Visit. The subjects will be randomized to either the carbamazepine or zonisamide arm at the Randomization Visit (T1). T1 must occur as soon as possible (and at least within 14 days) of the Screening Visit in order to optimize subject care.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy |
Drug: Zonisamide Drug: Carbamazepine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Multi-centre, Double-blind Study, to Compare the Efficacy and Safety of Zonisamide and Carbamazepine as Monotherapy, in Newly Diagnosed Partial Epilepsy |
| Estimated Enrollment: | 682 |
| Study Start Date: | May 2007 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: Zonisamide
Week 1 and 2 either 100mg zonisamide or 200 mg carbamazepine Week 3 and 4 either 200mg zonisamide or 4800 mg carbamazepine Week 5 and 6 either 300mg zonisamide or 600 mg carbamazepine; this dose then to be maintained unless a subject has a seizure more than two weeks post a dose increase.
Other Name: Zonegran
|
| Active Comparator: 2 |
Drug: Carbamazepine
Week 1 and 2 either 100mg zonisamide or 200 mg carbamazepine Week 3 and 4 either 200mg zonisamide or 4800 mg carbamazepine Week 5 and 6 either 300mg zonisamide or 600 mg carbamazepine; this dose then to be maintained unless a subject has a seizure more than two weeks post a dose increase.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
Subjects will be eligible for the study if they meet all of the following inclusion criteria:
EXCLUSION CRITERIA:
Subjects who meet any of the following exclusion criteria will not be eligible for the study:
Contacts and Locations
Show 80 Study Locations| Study Director: | Joanna Segieth | Eisai Limited |
More Information
| Responsible Party: | Medical Information Services, Eisai Ltd. |
| ClinicalTrials.gov Identifier: | NCT00477295 History of Changes |
| Other Study ID Numbers: | E2090-E044-310 |
| Study First Received: | May 21, 2007 |
| Last Updated: | March 17, 2011 |
| Health Authority: | European Union: European Medicines Agency |
|
Epilepsy |
|
Epilepsy Epilepsies, Partial Brain Diseases Central Nervous System Diseases Nervous System Diseases Carbamazepine Zonisamide Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |