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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00863538
First Posted: March 18, 2009
Last Update Posted: February 3, 2010
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.
Information provided by:
Kissei Pharmaceutical Co., Ltd.
March 16, 2009
March 18, 2009
February 3, 2010
Not Provided
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Scale for the assessment and rating of ataxia (SARA), ADL(Flow-FIM), Patient Improvement Impression [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT00863538 on ClinicalTrials.gov Archive Site
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Phase II Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
An Open-label, Phase II Study of KPS-0373 in Patients With SCD
To evaluate the efficacy, safety and pharmacokinetics profile of KPS-0373 in patients with SCD
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Spinocerebellar Degeneration
Drug: KPS-0373
Experimental: 1
Intervention: Drug: KPS-0373
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
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Inclusion Criteria:

  • SCD 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)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00863538
KPS1201
No
Not Provided
Not Provided
Not Provided
Kissei Pharmaceutical Co., Ltd.
Not Provided
Study Director: Yasuhiro Omori Kissei Pharmaceutical Co., Ltd.
Kissei Pharmaceutical Co., Ltd.
February 2010

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