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Completed

NCT Number: NCT01970098

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

The purpose of this study is to investigate the superiority of KPS-0373 to placebo, and evaluate the safety 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

Multiple Locations, 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

Exclusion criteria

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

Treatment and study plan

KPS-0373, High dose

Drug

28 weeks

KPS-0373, Low dose

Drug

28 weeks

Placebo

Drug

28 weeks

Primary outcomes

  1. SARA (Scale for the Assessment and Rating of Ataxia)

    Time frame: 24 weeks

    The change in the SARA total score at the time of final evaluation

Secondary outcomes

  1. SF-8 (QOL)

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 25, 2013
Registry last updated
Dec 14, 2018

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.

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