Phase II 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: NCT00863538 |
Recruitment Status
:
Completed
First Posted
: March 18, 2009
Last Update Posted
: February 3, 2010
|
Sponsor:
Kissei Pharmaceutical Co., Ltd.
Information provided by:
Kissei Pharmaceutical Co., Ltd.
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 |
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 |
40 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Study Completion Date | Not Provided | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender |
|
|||
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 |
|
|||
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 |