Back to results

A Phase II Double Blind Comparative Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

Primary Purpose

SCD

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

KPS-0373

Placebo

About this trial

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

Eligibility Criteria

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

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

Sites / Locations

Japan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

KPS-0373, lowest dose

KPS-0373, 2nd lowest dose

KPS-0373, 2nd highest dose

KPS-0373, highest dose

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in Scale for the assessment and rating of ataxia (SARA)

Secondary Outcome Measures

Change from baseline in patient improvement impression of activities of daily living

Full Information

NCT ID

NCT01384435

First Posted

June 23, 2011

Last Updated

November 29, 2012

Sponsor

Kissei Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01384435

Brief Title

A Phase II Double Blind Comparative Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

Official Title

A Randomized, Double Blind, Placebo-controlled Phase II Study of KPS-0373 in Patients With SCD

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

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

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of KPS-0373 compared to placebo in patients with Spinocerebellar Degeneration (SCD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

SCD

Keywords

Spinocerebellar degeneration (SCD), Thyrotropin-Releasing Hormone (TRH)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

KPS-0373, lowest dose

Arm Type

Experimental

Arm Title

KPS-0373, 2nd lowest dose

Arm Type

Experimental

Arm Title

KPS-0373, 2nd highest dose

Arm Type

Experimental

Arm Title

KPS-0373, highest dose

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

KPS-0373

Intervention Type

Drug

Intervention Name(s)

KPS-0373

Intervention Type

Drug

Intervention Name(s)

KPS-0373

Intervention Type

Drug

Intervention Name(s)

KPS-0373

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Change from baseline in Scale for the assessment and rating of ataxia (SARA)

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Change from baseline in patient improvement impression of activities of daily living

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Katsumi Hontani

Organizational Affiliation

Clinical Research Dept.

Official's Role

Study Director

Facility Information:

Facility Name

Japan

City

Tokyo and Other Japanese City

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

A Phase II Double Blind Comparative Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

We'll reach out to this number within 24 hrs