Assessing The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures
Tracking Information
Start Date ICMJE | September 2008 |
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Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: February 19, 2009) | Primary outcome measure will assess the occurrence of seizures which will be documented in a seizure diary to be maintained by the subjects. The diaries will contain information on the type and frequency of seizures. [ Time Frame: Subjects will attend the clinic at intervals of every 13 weeks until the end of the study. Subjects will attend the clinic for unscheduled visits if seizures occur. ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00848549 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: February 19, 2009) | Secondary outcome measures will include the occurrence of adverse events (AEs), the results of laboratory tests, physical examinations, vital signs, and the assessment of the Quality of Life in Epilepsy (QOLIE) Questionnaire. [ Time Frame: Subjects will attend the clinic at intervals of every 13 weeks until the end of the study. Subjects will attend the clinic for unscheduled visits if seizures occur. ] [ Designated as safety issue: Yes ] |
Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Assessing The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures |
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Official Title ICMJE | 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 |
Brief Summary | 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. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Epilepsy |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 580 | ||||
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Estimated Completion Date | May 2013 | ||||
Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 78 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Australia, Denmark, France, Germany, Greece, Hungary, India, Italy, Korea, Republic of, Montenegro, Poland, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00848549 | ||||
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Responsible Party | Medical Information Department; Eisai Ltd., Eisai Limited | ||||
Study ID Numbers ICMJE | E2090-E044-314 | ||||
Study Sponsor ICMJE | Eisai Inc. | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Eisai Inc. |
Source: http://clinicaltrials.gov/