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

A 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
NCT01970098
Enrollment
374
Registered
2013-10-25
Start date
2013-10-09
Completion date
2015-01-31
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

Keywords

Spinocerebellar degeneration (SCD), Thyrotropin-Releasing Hormone (TRH), Spinocerebellar Ataxia (SCA), Cortical Cerebellar Atrophy (CCA)

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.

Interventions

DRUGKPS-0373, High dose

28 weeks

DRUGKPS-0373, Low dose

28 weeks

DRUGPlacebo

28 weeks

Sponsors

Kissei Pharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum

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

MeasureTime frameDescription
SARA (Scale for the Assessment and Rating of Ataxia)24 weeksThe change in the SARA total score at the time of final evaluation

Secondary

MeasureTime frame
SF-8 (QOL)24 weeks

Countries

Japan

Outcome results

None listed

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