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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 14, 2005 | ||||
| Last Updated Date | May 7, 2008 | ||||
| Start Date ICMJE | October 2005 | ||||
| Primary Completion Date | July 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Seizure frequency, compared to baseline. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00215592 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE |
Safety, Quality of Life. | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Open Label, Zonegran (Zonisamide) In Partial Onset Seizures | ||||
| Official Title ICMJE | An Open Label Study Of Zonegran (Zonisamide) In Patients With Partial Onset Seizures | ||||
| Brief Summary | To determine the efficacy and safety of adjunctive open label Zonegran treatment in patients with refractory partial seizures. |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Epilepsy | ||||
| Intervention ICMJE | Drug: Zonegran | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1000 | ||||
| Completion Date | |||||
| Primary Completion Date | July 2007 (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 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Austria, Denmark, France, Germany, Italy, Norway, United Kingdom | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00215592 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | E2090-E044-401 | ||||
| Study Sponsor ICMJE | Eisai Limited | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Eisai Inc. | ||||
| Verification Date | April 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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