Back to resultsA Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
Primary Purpose
Spinocerebellar Degeneration
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
KPS-0373
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Spinocerebellar Degeneration focused on measuring Spinocerebellar degeneration, Thyrotropin-Releasing Hormone (TRH), SCD
Eligibility Criteria
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
Sites / Locations
- Japan
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
KPS-0373
Arm Description
Outcomes
Primary Outcome Measures
Scale for Assessment and Rating of Ataxia (SARA)
Upper and lower extremity function
Secondary Outcome Measures
Full Information
NCT ID
NCT01004016
First Posted
October 27, 2009
Last Updated
September 27, 2010
Sponsor
Kissei Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01004016
Brief Title
A Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
Official Title
A Double-blind, Placebo-controlled, Crossover Study, Followed by Open-label Study of KPS-0373 in Patients With SCD
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Kissei Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the efficacy and safety of KPS-0373 in patients with SCD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinocerebellar Degeneration
Keywords
Spinocerebellar degeneration, Thyrotropin-Releasing Hormone (TRH), SCD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
KPS-0373
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
KPS-0373
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Scale for Assessment and Rating of Ataxia (SARA)
Time Frame
4 weeks + 12 weeks
Title
Upper and lower extremity function
Time Frame
4 weeks + 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasuhiro Omori
Organizational Affiliation
Clinical Development Department, Kissei Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Japan
City
Japan
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
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