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

Primary Purpose

Spinocerebellar Degeneration

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
KPS-0373
Sponsored by
Kissei Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinocerebellar Degeneration focused on measuring Spinocerebellar degeneration, Thyrotropin-Releasing Hormone (TRH), SCD

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • SCD with mild to moderate ataxia

Exclusion Criteria:

  • Patients with secondary ataxia
  • Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Sites / Locations

  • Japan
  • Japan
  • Japan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Scale for the assessment and rating of ataxia (SARA), ADL(Flow-FIM), Patient Improvement Impression

Secondary Outcome Measures

Full Information

First Posted
March 16, 2009
Last Updated
February 1, 2010
Sponsor
Kissei Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00863538
Brief Title
Phase II Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
Official Title
An Open-label, Phase II Study of KPS-0373 in Patients With SCD
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Kissei Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the efficacy, safety and pharmacokinetics profile of KPS-0373 in patients with SCD

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinocerebellar Degeneration
Keywords
Spinocerebellar degeneration, Thyrotropin-Releasing Hormone (TRH), SCD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
KPS-0373
Primary Outcome Measure Information:
Title
Scale for the assessment and rating of ataxia (SARA), ADL(Flow-FIM), Patient Improvement Impression
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: SCD with mild to moderate ataxia Exclusion Criteria: Patients with secondary ataxia Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasuhiro Omori
Organizational Affiliation
Kissei Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Japan
City
Hokkaido Region
Country
Japan
Facility Name
Japan
City
Kansai Region
Country
Japan
Facility Name
Japan
City
Kanto Region
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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