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Phase II 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:
NCT00863538
First received: March 16, 2009
Last updated: February 1, 2010
Last verified: February 2010

March 16, 2009
February 1, 2010
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Scale for the assessment and rating of ataxia (SARA), ADL(Flow-FIM), Patient Improvement Impression [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00863538
KPS1201
No
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