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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: 12 December 2020
Main ID:  NCT01970098
Date of registration: 22/10/2013
Prospective Registration: No
Primary sponsor: Kissei Pharmaceutical Co., Ltd.
Public title: A Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
Scientific title: A Phase III Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
Date of first enrolment: October 9, 2013
Target sample size: 374
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01970098
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).  
Phase:  Phase 3
Countries of recruitment
Japan
Contacts
Name:     Tatsuro Takei
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Spinocerebellar Degeneration
Intervention(s)
Drug: KPS-0373, Low dose
Drug: KPS-0373, High dose
Drug: Placebo
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]
Secondary ID(s)
KPS1301
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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