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Completed

NCT Number: NCT01384435

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

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

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Key information

Conditions

SCD 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 2

Primary location

Japan

Tokyo and Other Japanese City, 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

Placebo

Drug

Primary outcomes

  1. Change from baseline in Scale for the assessment and rating of ataxia (SARA)

    Time frame: 24 weeks

Secondary outcomes

  1. Change from baseline in patient improvement impression of activities of daily living

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

First posted
Jun 29, 2011
Registry last updated
Dec 3, 2012

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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