A Phase II Double Blind Comparative Study of KPS-0373 in... | NCT01384435

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

NCT01384435

Sponsor

Kissei Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Dec 3, 2012Estimated

Enrollment

200Estimated

Phase

Phase 2

Conditions

Interventions

KPS-0373
KPS-0373
KPS-0373
KPS-0373
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 23, 2011

First Submission Date that Met QC Criteria

Jun 27, 2011

First Posted Date

Jun 29, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 29, 2012

Last Update Posted Date

Dec 3, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
KPS-0373, lowest dose	Experimental	Drug: KPS-0373
KPS-0373, 2nd lowest dose	Experimental	Drug: KPS-0373
KPS-0373, 2nd highest dose	Experimental	Drug: KPS-0373
KPS-0373, highest dose	Experimental	Drug: KPS-0373
Placebo	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KPS-0373	Drug		KPS-0373, lowest dose
KPS-0373

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in Scale for the assessment and rating of ataxia (SARA)		24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in patient improvement impression of activities of daily living		24 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Katsumi Hontani	Clinical Research Dept.	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D013132	Spinocerebellar Degenerations

Ancestor Terms

ID	Term
D002526	Cerebellar Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided