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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01970111
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), Cortical Cerebellar Atrophy (CCA)

Brief summary

The purpose of this study is to evaluate the long-term safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients.

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 mild to moderate ataxia (Completion of the KPS1301 study)

Exclusion criteria

* Less than 75% of compliance in KPS1301 study

Design outcomes

Primary

MeasureTime frame
SARA (Scale for the Assessment and Rating of Ataxia)52 weeks

Secondary

MeasureTime frame
SF-8 (QOL)52 weeks

Countries

Japan

Outcome results

None listed

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