Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07040137

Confirmatory Study 3 of KPS-0373 in Patients With Spinocerebellar Degeneration

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase III study to evaluate the efficacy and safety of KPS-0373 given once daily after breakfast in 142 patients with spinocerebellar degeneration . This study consists of the 4-week screening period, 24-week treatment period, and 4-week follow-up period.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Spinocerebellar Degeneration Brain Diseases Central Nervous System Diseases Cerebellar Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Nervous System Diseases Neurodegenerative Diseases Spinal Cord Diseases Spinocerebellar Degenerations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site

Multiple Locations, Japan

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KPS-0373

Drug

Oral administration

Placebo

Drug

Oral administration

Primary outcomes

  1. Change from baseline in SARA total score at 24 weeks of treatment period

    Time frame: Up to 24 weeks

    The SARA is a scale that assesses cerebellar ataxia. An evaluator observes the subject's ability to perform motor activities across in 8 individual items: ("gait: 0-8 points," "stance: 0-6 points," "sitting: 0-4 points," "speech disturbance: 0-6 points," "finger chase: 0-4 points," "nose-finger test: 0-4 points," "fast alternating hand movements: 0-4 points," and "heel-shin slide: 0-4 points." The total SARA score ranges from 0 (no ataxia) to 40 (severe ataxia).

Secondary outcomes

  1. Change from baseline in SARA total score

    Time frame: Up to 24 weeks

    The SARA is a scale that assesses cerebellar ataxia. An evaluator observes the subject's ability to perform motor activities across in 8 individual items: ("gait: 0-8 points," "stance: 0-6 points," "sitting: 0-4 points," "speech disturbance: 0-6 points," "finger chase: 0-4 points," "nose-finger test: 0-4 points," "fast alternating hand movements: 0-4 points," and "heel-shin slide: 0-4 points." The total SARA score ranges from 0 (no ataxia) to 40 (severe ataxia).

  2. Symptom Maintenance Ratio (Ratio of Improvement and Stability Cases) based on SARA total score

    Time frame: Up to 24 weeks

    Subjects with the change in total SARA score from baseline of ≤ -1 point are defined as improved subjects, subjects with the change in total SARA score of > -1 point and < 1 point as unchanged subjects, and subjects with improvement and subjects with no change are defined as subjects maintaining symptoms.

  3. Change from baseline in SARA individual scores

    Time frame: Up to 24 weeks

    The SARA is a scale that assesses cerebellar ataxia. An evaluator observes the subject's ability to perform motor activities across in 8 individual items: ("gait: 0-8 points," "stance: 0-6 points," "sitting: 0-4 points," "speech disturbance: 0-6 points," "finger chase: 0-4 points," "nose-finger test: 0-4 points," "fast alternating hand movements: 0-4 points," and "heel-shin slide: 0-4 points." The total SARA score ranges from 0 (no ataxia) to 40 (severe ataxia).

  4. Change from baseline in SF-8

    Time frame: Up to 24 weeks

    SF-8 is a questionnaire that comprehensively measures health-related QOL. Subjects answer questions in the following 8 items on a scale of 5 or 6: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. A higher score indicates better health in that item.

Study contacts

Contact information is provided by the study sponsor or research team.

Kissei Pharmaceutical Co., Ltd Kissei Pharmaceutical Co., Ltd

CONTACT

[email protected]

Email only

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Phase III Confirmatory Study 3 of KPS-0373 in Patients With Spinocerebellar Degeneration

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 27, 2025
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.