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

This study has been completed.
Sponsor:
Information provided by:
Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01004016
First received: October 27, 2009
Last updated: September 27, 2010
Last verified: September 2010

October 27, 2009
September 27, 2010
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  • Scale for Assessment and Rating of Ataxia (SARA) [ Time Frame: 4 weeks + 12 weeks ] [ Designated as safety issue: No ]
  • Upper and lower extremity function [ Time Frame: 4 weeks + 12 weeks ] [ Designated as safety issue: No ]
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Spinocerebellar Degeneration
  • Drug: KPS-0373
  • Drug: Placebo
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: KPS-0373
    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
20
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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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01004016
KPS1202
No
Not Provided
Kissei Pharmaceutical Co., Ltd.
Not Provided
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