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Phase II Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

An Open-label, Phase II Study of KPS-0373 in Patients With SCD

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00863538
Enrollment
40
Registered
2009-03-18
Start date
Unknown
Completion date
Unknown
Last updated
2010-02-03

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, Thyrotropin-Releasing Hormone (TRH), SCD

Brief summary

To evaluate the efficacy, safety and pharmacokinetics profile of KPS-0373 in patients with SCD

Interventions

Sponsors

Kissei Pharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* SCD with mild to moderate ataxia

Exclusion criteria

* Patients with secondary ataxia * Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Design outcomes

Primary

MeasureTime frame
Scale for the assessment and rating of ataxia (SARA), ADL(Flow-FIM), Patient Improvement Impression12 weeks

Countries

Japan

Outcome results

None listed

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