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A 24-week Open-label Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01970137
Enrollment
Unknown
Registered
2013-10-25
Start date
Unknown
Completion date
Unknown
Last updated
2016-04-18

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)

Brief summary

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients (Experience of clinical trials of KPS-0373)

Interventions

DRUGKPS-0373, High dose
DRUGKPS-0373, Low dose

Sponsors

Kissei Pharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum

Inclusion criteria

* Japanese SCD patients with ataxia (Experience of clinical trials of KPS-0373)

Exclusion criteria

* Patients with secondary ataxia * Patients with clinically significant hepatic, renal, or cardiovascular dysfunction * Discontinuations in another clinical trials caused by side effects

Design outcomes

Primary

MeasureTime frame
SARA (Scale for the Assessment and Rating of Ataxia)24 weeks

Secondary

MeasureTime frame
SF-8 (QOL)24 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026