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Sponsored by: |
Eisai Inc. |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00848549 |
The purpose of this study is to assess the long-term safety and tolerability and to explore the long-term efficacy of zonisamide as monotherapy treatment in subjects with newly diagnosed partial seizures.
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), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind Extension Study To Assess The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures |
Estimated Enrollment: | 580 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | May 2013 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator |
Drug: Zonisamide
Subjects will start on the same dose that was achieved at the end of study E2090-E044-310. Maximum daily dose allowable is 500 mg; the minimum daily dose allowable is 200 mg. During the study, subjects will be titrated up or down depending on seizure-free status or intolerability/adverse events, respectively. Should a dose outside of the maximum be required the subject will be with drawn and gradually down titrated by 100 mg per week.
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2: Active Comparator |
Drug: Carbamazepine
Subjects will start on the same dose that was achieved at the end of study E2090-E044-310. Maximum daily dose allowable is 1200 mg; the minimum daily dose allowable is 400 mg. During the study, subjects will be titrated up or down depending on seizure-free status or intolerability/adverse events respectively. Should a dose outside of the maximum be required the subject will be with drawn and gradually down titrated by 200 mg per week.
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Ages Eligible for Study: | 18 Years to 78 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Medical Information Department; Eisai Ltd. | 02086001400 | med_info@eisai.net |
Study Director: | Rob van Maanen, M.D. | Eisai Limited |
Responsible Party: | Eisai Limited ( Medical Information Department; Eisai Ltd. ) |
Study ID Numbers: | E2090-E044-314 |
Study First Received: | February 19, 2009 |
Last Updated: | August 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00848549 History of Changes |
Health Authority: | European Union: European Medicines Agency |
Epilepsy Monotherapy |
Antioxidants Tranquilizing Agents Seizures 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 |
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 |