|
Main
|
|
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. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
25 April 2016 |
|
Main ID: |
NCT01970137 |
|
Date of registration:
|
22/10/2013 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
A 24-week Open-label Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
|
|
Scientific title:
|
|
|
Date of first enrolment:
|
October 2013 |
|
Target sample size:
|
|
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01970137 |
|
Study type:
|
Interventional |
|
Study design:
|
N/A
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Japanese SCD patients with ataxia (Experience of clinical trials of KPS-0373)
Exclusion Criteria:
- Patients with secondary ataxia
- Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
- Discontinuations in another clinical trials caused by side effects
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Spinocerebellar Degeneration
|
|
Intervention(s)
|
|
Drug: KPS-0373, High dose
|
|
Drug: KPS-0373, Low dose
|
|
Primary Outcome(s)
|
|
SARA (Scale for the Assessment and Rating of Ataxia)
[Time Frame: 24 weeks]
|
|
Secondary Outcome(s)
|
|
SF-8 (QOL)
[Time Frame: 24 weeks]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|