Back to resultsA 24-week Open-label Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
Primary Purpose
Spinocerebellar Degeneration
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
KPS-0373, High dose
KPS-0373, Low dose
Sponsored by
About this trial
This is an interventional trial for Spinocerebellar Degeneration focused on measuring Spinocerebellar degeneration (SCD), Thyrotropin-Releasing Hormone (TRH), Spinocerebellar Ataxia (SCA)
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
KPS-0373
Arm Description
Outcomes
Primary Outcome Measures
SARA (Scale for the Assessment and Rating of Ataxia)
Secondary Outcome Measures
SF-8 (QOL)
Full Information
NCT ID
NCT01970137
First Posted
October 22, 2013
Last Updated
April 15, 2016
Sponsor
Kissei Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01970137
Brief Title
A 24-week Open-label Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
October 2014 (Actual)
Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kissei Pharmaceutical Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients (Experience of clinical trials of KPS-0373)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinocerebellar Degeneration
Keywords
Spinocerebellar degeneration (SCD), Thyrotropin-Releasing Hormone (TRH), Spinocerebellar Ataxia (SCA)
7. Study Design
Study Phase
Phase 3
8. Arms, Groups, and Interventions
Arm Title
KPS-0373
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
KPS-0373, High dose
Intervention Type
Drug
Intervention Name(s)
KPS-0373, Low dose
Primary Outcome Measure Information:
Title
SARA (Scale for the Assessment and Rating of Ataxia)
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
SF-8 (QOL)
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Eligibility 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
Facility Information:
City
Tokyo and Other Japanese Cities
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A 24-week Open-label Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
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