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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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12 December 2020 |
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Main ID: |
NCT01970098 |
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Date of registration:
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22/10/2013 |
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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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A Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
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Scientific title:
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A Phase III Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD) |
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Date of first enrolment:
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October 9, 2013 |
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Target sample size:
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374 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01970098 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 3
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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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Tatsuro Takei |
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Japanese SCD patients 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:
All
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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, Low dose
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Drug: KPS-0373, High dose
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Drug: Placebo
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Primary Outcome(s)
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SARA (Scale for the Assessment and Rating of Ataxia)
[Time Frame: 24 weeks]
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Secondary Outcome(s)
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SF-8 (QOL)
[Time Frame: 24 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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