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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00863538 |
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Date of registration:
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16/03/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase II Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
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Scientific title:
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An Open-label, Phase II Study of KPS-0373 in Patients With SCD |
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Date of first enrolment:
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November 2004 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00863538 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Japan
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Contacts
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Name:
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Yasuhiro Omori |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kissei Pharmaceutical Co., Ltd. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- SCD with mild to moderate ataxia
Exclusion Criteria:
- Patients with secondary ataxia
- Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Spinocerebellar Degeneration
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Intervention(s)
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Drug: KPS-0373
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Primary Outcome(s)
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Scale for the assessment and rating of ataxia (SARA), ADL(Flow-FIM), Patient Improvement Impression
[Time Frame: 12 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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