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

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

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tokyo and Other Japanese Cities, Japan

Who can participate

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

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

Treatment and study plan

KPS-0373, High dose

Drug

KPS-0373, Low dose

Drug

Primary outcomes

SARA (Scale for the Assessment and Rating of Ataxia)

Time frame: 52 weeks

Secondary outcomes

SF-8 (QOL)

Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Primary completion: 2015
First posted: Oct 25, 2013
Registry last updated: Apr 18, 2016

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.

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

Completed