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Phase II Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
This study has been completed.
Sponsor:
Kissei Pharmaceutical Co., Ltd.
Information provided by:
Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00863538
First received: March 16, 2009
Last updated: February 1, 2010
Last verified: February 2010
| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | March 16, 2009 | |||
| Last Updated Date | February 1, 2010 | |||
| Start Date ICMJE | Not Provided | |||
| Primary Completion Date | Not Provided | |||
| Current Primary Outcome Measures ICMJE |
Scale for the assessment and rating of ataxia (SARA), ADL(Flow-FIM), Patient Improvement Impression [ Time Frame: 12 weeks ] | |||
| Original Primary Outcome Measures ICMJE | Same as current | |||
| Change History | Complete list of historical versions of study NCT00863538 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE | Not Provided | |||
| Original Secondary Outcome Measures ICMJE | Not Provided | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Phase II Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD) | |||
| Official Title ICMJE | An Open-label, Phase II Study of KPS-0373 in Patients With SCD | |||
| Brief Summary | To evaluate the efficacy, safety and pharmacokinetics profile of KPS-0373 in patients with SCD | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase | Phase 2 | |||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Spinocerebellar Degeneration | |||
| Intervention ICMJE | Drug: KPS-0373 | |||
| Study Arms | Experimental: 1
Intervention: Drug: KPS-0373 |
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| Publications * | Not Provided | |||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Estimated Enrollment ICMJE | 40 | |||
| Completion Date | Not Provided | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 20 Years and older (Adult, Senior) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Japan | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00863538 | |||
| Other Study ID Numbers ICMJE | KPS1201 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| Plan to Share Data | Not Provided | |||
| IPD Description | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Kissei Pharmaceutical Co., Ltd. | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | Kissei Pharmaceutical Co., Ltd. | |||
| Verification Date | February 2010 | |||
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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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