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:

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

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

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 ^ICMJE

Phase 2

Study Design ^ICMJE

Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Spinocerebellar Degeneration

Intervention ^ICMJE

Drug: KPS-0373

Study Arms ^ICMJE

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

Original Estimated Enrollment ^ICMJE

Same as current

Study Completion Date ^ICMJE

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 ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

20 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

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 ^ICMJE

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

To Top