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Clinical Trials/NCT02889302
NCT02889302CompletedPhase 3

An Additional Phase III Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

Kissei Pharmaceutical Co., Ltd.0 sites203 target enrollmentStarted: November 15, 2016Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
203
Primary Endpoint
SARA (Scale for the Assessment and Rating of Ataxia)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to investigate the superiority of KPS-0373 to placebo, and evaluate the safety of KPS-0373 in SCD patients.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

KPS-0373

Experimental

Intervention: KPS-0373 (Drug)

Placebo

Placebo Comparator

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

SARA (Scale for the Assessment and Rating of Ataxia)

Time Frame: 24 weeks

The change in the SARA total score at the time of final evaluation

Secondary Outcomes

  • SF-8(QOL)(24 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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