An Additional Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

December 12, 2018 updated by: Kissei Pharmaceutical Co., Ltd.

An Additional Phase III Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

The purpose of this study is to investigate the superiority of KPS-0373 to placebo, and evaluate the safety of KPS-0373 in SCD patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

203

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Multiple Locations, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
24 weeks
EXPERIMENTAL: KPS-0373
Drug: KPS-0373
24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SARA (Scale for the Assessment and Rating of Ataxia)
Time Frame: 24 weeks
The change in the SARA total score at the time of final evaluation
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
SF-8(QOL)
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kissei Pharmaceutical Co., Ltd.

Investigators

  • Study Director: Nobuo Kanai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 15, 2016

Primary Completion (ACTUAL)

March 1, 2018

Study Completion (ACTUAL)

March 1, 2018

Study Registration Dates

First Submitted

August 31, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (ESTIMATE)

September 5, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 14, 2018

Last Update Submitted That Met QC Criteria

December 12, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KPS1305

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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