A Phase II Double Blind Comparative Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

A Randomized, Double Blind, Placebo-controlled Phase II Study of KPS-0373 in Patients With SCD

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01384435

Enrollment

200

Registered

2011-06-29

Start date

Unknown

Completion date

Unknown

Last updated

2012-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SCD

Keywords

Spinocerebellar degeneration (SCD), Thyrotropin-Releasing Hormone (TRH)

Brief summary

The purpose of this study is to evaluate the efficacy and safety of KPS-0373 compared to placebo in patients with Spinocerebellar Degeneration (SCD).

Interventions

DRUGKPS-0373

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

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
Change from baseline in Scale for the assessment and rating of ataxia (SARA)	24 weeks

Secondary

Measure	Time frame
Change from baseline in patient improvement impression of activities of daily living	24 weeks

Countries

Japan

Outcome results

None listed

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