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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02889302

Enrollment

203

Registered

2016-09-05

Start date

2016-11-15

Completion date

2018-03-31

Last updated

2018-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinocerebellar Degeneration

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.

Interventions

DRUGKPS-0373

24 weeks

DRUGPlacebo

24 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
SARA (Scale for the Assessment and Rating of Ataxia)	24 weeks	The change in the SARA total score at the time of final evaluation

Secondary

Measure	Time frame
SF-8(QOL)	24 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026