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Sponsored by: |
Eisai Inc. |
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Information provided by: | Eisai Inc. |
ClinicalTrials.gov Identifier: | NCT00477295 |
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 |
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Epilepsy |
Drug: Zonisamide Drug: Carbamazepine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
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: | 582 |
Study Start Date: | May 2007 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
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.
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2: Active Comparator |
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.
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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:
Subjects have progressive encephalopathy or findings consistent with progressive CNS disease or lesion (e.g.
infection, demyelination, or tumour).
Contact: Eisai Ltd. | 0208 600 1400 |
France | |
Bat. Paul Castaigne Hopital de la Pitie-Salpetriere | Recruiting |
Paris, France, 75013 |
Study Director: | Robert van Maanen, MD | Eisai Limited |
Responsible Party: | Eisai Ltd. ( Medical Information Services ) |
Study ID Numbers: | E2090-E044-310 |
Study First Received: | May 21, 2007 |
Last Updated: | September 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00477295 History of Changes |
Health Authority: | European Union: European Medicines Agency |
Epilepsy |
Epilepsies, Partial Antioxidants Tranquilizing Agents Zonisamide Psychotropic Drugs Central Nervous System Diseases Central Nervous System Depressants Brain Diseases |
Antimanic Agents Carbamazepine Epilepsy Analgesics, Non-Narcotic Analgesics Peripheral Nervous System Agents Anticonvulsants |
Epilepsies, Partial Antioxidants Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Zonisamide Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Central Nervous System Diseases Antimanic Agents Brain Diseases |
Protective Agents Pharmacologic Actions Carbamazepine Epilepsy Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |