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OpenTrials
Completed

NCT Number: NCT00863538

Phase II Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

To evaluate the efficacy, safety and pharmacokinetics profile of KPS-0373 in patients with SCD

Completed

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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 2

Primary location

Japan, Hokkaido Region

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • SCD 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

Primary outcomes

  1. Scale for the assessment and rating of ataxia (SARA), ADL(Flow-FIM), Patient Improvement Impression

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

An Open-label, Phase II Study of KPS-0373 in Patients With SCD

Important dates

First posted
Mar 18, 2009
Registry last updated
Feb 3, 2010

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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