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

A Double-blind, Placebo-controlled, Crossover Study, Followed by Open-label Study of KPS-0373 in Patients With SCD

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01004016

Enrollment

Registered

2009-10-29

Start date

Unknown

Completion date

Unknown

Last updated

2010-09-28

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 and safety of KPS-0373 in patients with SCD.

Interventions

DRUGKPS-0373

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

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
Scale for Assessment and Rating of Ataxia (SARA)	4 weeks + 12 weeks
Upper and lower extremity function	4 weeks + 12 weeks

Countries

Japan

Outcome results

None listed

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