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Completed

NCT Number: NCT02889302

An Additional 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 of KPS-0373 in SCD patients.

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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

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Multiple Locations, Japan

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

24 weeks

Placebo

Drug

24 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

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 5, 2016
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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