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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01004016
Recruitment Status : Completed
First Posted : October 29, 2009
Last Update Posted : September 28, 2010
Information provided by:
Kissei Pharmaceutical Co., Ltd.

October 27, 2009
October 29, 2009
September 28, 2010
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  • Scale for Assessment and Rating of Ataxia (SARA) [ Time Frame: 4 weeks + 12 weeks ]
  • Upper and lower extremity function [ Time Frame: 4 weeks + 12 weeks ]
Same as current
Complete list of historical versions of study NCT01004016 on ClinicalTrials.gov Archive Site
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A Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
A Double-blind, Placebo-controlled, Crossover Study, Followed by Open-label Study of KPS-0373 in Patients With SCD
To evaluate the efficacy and safety of KPS-0373 in patients with SCD.
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Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Spinocerebellar Degeneration
  • Drug: KPS-0373
  • Drug: Placebo
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: KPS-0373
    Intervention: Drug: KPS-0373
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Kissei Pharmaceutical Co., Ltd.
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Study Director: Yasuhiro Omori Clinical Development Department, Kissei Pharmaceutical Co., Ltd.
Kissei Pharmaceutical Co., Ltd.
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP