- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01970098
A Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
December 12, 2018 updated by: Kissei Pharmaceutical Co., Ltd.
A Phase III Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
374
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Multiple Locations, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
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28 weeks
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EXPERIMENTAL: KPS-0373
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28 weeks
28 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SARA (Scale for the Assessment and Rating of Ataxia)
Time Frame: 24 weeks
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The change in the SARA total score at the time of final evaluation
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24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
SF-8 (QOL)
Time Frame: 24 weeks
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Tatsuro Takei
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 9, 2013
Primary Completion (ACTUAL)
January 1, 2015
Study Completion (ACTUAL)
January 1, 2015
Study Registration Dates
First Submitted
October 22, 2013
First Submitted That Met QC Criteria
October 22, 2013
First Posted (ESTIMATE)
October 25, 2013
Study Record Updates
Last Update Posted (ACTUAL)
December 14, 2018
Last Update Submitted That Met QC Criteria
December 12, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Genetic Diseases, Inborn
- Neurodegenerative Diseases
- Dyskinesias
- Spinal Cord Diseases
- Heredodegenerative Disorders, Nervous System
- Cerebellar Diseases
- Ataxia
- Cerebellar Ataxia
- Spinocerebellar Ataxias
- Spinocerebellar Degenerations
Other Study ID Numbers
- KPS1301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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