A 24-week Open-label Study of KPS-0373 in Patients With S... | NCT01970137

Studies
A 24-week Open-label Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

NCT01970137

Sponsor

Kissei Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Apr 18, 2016Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Spinocerebellar Degeneration

Interventions

KPS-0373, High dose
KPS-0373, Low dose

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

Apr 2016

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

Oct 2014Actual

Completion Date

Not provided

First Submitted Date

Oct 22, 2013

First Submission Date that Met QC Criteria

Oct 22, 2013

First Posted Date

Oct 25, 2013Estimated

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

Apr 15, 2016

Last Update Posted Date

Apr 18, 2016Estimated

Description Module

Brief Summary

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients (Experience of clinical trials of KPS-0373)

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 3

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Label	Type	Description	Intervention Names
KPS-0373	Experimental		Drug: KPS-0373, High dose Drug: KPS-0373, Low dose

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

Measure	Description	Time Frame
SARA (Scale for the Assessment and Rating of Ataxia)		24 weeks

Measure	Description	Time Frame
SF-8 (QOL)		24 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Japanese SCD patients with ataxia (Experience of clinical trials of KPS-0373)

Exclusion Criteria:

Patients with secondary ataxia
Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Discontinuations in another clinical trials caused by side effects

Accepts Healthy Volunteers

Not provided

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

Condition Browse Module

MeSH Terms

ID	Term
D013132	Spinocerebellar Degenerations
D020754	Spinocerebellar Ataxias

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