Back to resultsA Confirmatory 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
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Spinocerebellar Degeneration focused on measuring Spinocerebellar degeneration (SCD), Thyrotropin-Releasing Hormone (TRH), Spinocerebellar Ataxia (SCA), Cortical Cerebellar Atrophy (CCA)
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
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
KPS-0373
Placebo
Arm Description
Outcomes
Primary Outcome Measures
SARA (Scale for the Assessment and Rating of Ataxia)
The change in the SARA total score at the time of final evaluation
Secondary Outcome Measures
SF-8 (QOL)
Full Information
NCT ID
NCT01970098
First Posted
October 22, 2013
Last Updated
December 12, 2018
Sponsor
Kissei Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01970098
Brief Title
A Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
Official Title
A Phase III Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 9, 2013 (Actual)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
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 investigate the superiority of KPS-0373 to placebo, and evaluate the safety and pharmacokinetics of KPS-0373 in SCD patients.
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), Cortical Cerebellar Atrophy (CCA)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
374 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KPS-0373
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
KPS-0373, High dose
Intervention Description
28 weeks
Intervention Type
Drug
Intervention Name(s)
KPS-0373, Low dose
Intervention Description
28 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
28 weeks
Primary Outcome Measure Information:
Title
SARA (Scale for the Assessment and Rating of Ataxia)
Description
The change in the SARA total score at the time of final evaluation
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 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
Tatsuro Takei
Official's Role
Study Director
Facility Information:
City
Multiple Locations
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
31937586
Citation
Nishizawa M, Onodera O, Hirakawa A, Shimizu Y, Yamada M; Rovatirelin Study Group. Effect of rovatirelin in patients with cerebellar ataxia: two randomised double-blind placebo-controlled phase 3 trials. J Neurol Neurosurg Psychiatry. 2020 Mar;91(3):254-262. doi: 10.1136/jnnp-2019-322168. Epub 2020 Jan 14.
Results Reference
derived
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A Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
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