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

This study has been completed.

Sponsor:

Information provided by:

Kissei Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT00863538

First received: March 16, 2009

Last updated: February 1, 2010

Last verified: February 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

March 16, 2009

Last Updated Date

February 1, 2010

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

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

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

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

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