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

Tracking Information
First Submitted Date ICMJE	March 16, 2009
First Posted Date ICMJE	March 18, 2009
Last Update Posted Date	February 3, 2010
Study Start Date ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: March 17, 2009)	Scale for the assessment and rating of ataxia (SARA), ADL(Flow-FIM), Patient Improvement Impression [ Time Frame: 12 weeks ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00863538 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Phase II Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
Official Title ICMJE	An Open-label, Phase II Study of KPS-0373 in Patients With SCD
Brief Summary	To evaluate the efficacy, safety and pharmacokinetics profile of KPS-0373 in patients with SCD
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Spinocerebellar Degeneration
Intervention ICMJE	Drug: KPS-0373
Study Arms	Experimental: 1; Intervention: Drug: KPS-0373
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Estimated Enrollment ICMJE; (submitted: March 17, 2009)	40
Original Estimated Enrollment ICMJE	Same as current
Study Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	Inclusion Criteria: SCD with mild to moderate ataxia Exclusion Criteria: Patients with secondary ataxia; Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Sex/Gender	Sexes Eligible for Study: All
Ages	20 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Japan
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00863538
Other Study ID Numbers ICMJE	KPS1201
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Kissei Pharmaceutical Co., Ltd.
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Yasuhiro Omori Kissei Pharmaceutical Co., Ltd.
PRS Account	Kissei Pharmaceutical Co., Ltd.
Verification Date	February 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP