A Confirmatory Study of KPS-0373 in Patients With Spinoce... | NCT01970098

Studies
A Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

NCT01970098

Sponsor

Kissei Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Dec 14, 2018Actual

Enrollment

374Actual

Phase

Phase 3

Conditions

Spinocerebellar Degeneration

Interventions

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

Dec 2018

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

Oct 9, 2013Actual

Primary Completion Date

Jan 2015Actual

Completion Date

Jan 2015Actual

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

Dec 12, 2018

Last Update Posted Date

Dec 14, 2018Actual

Description Module

Brief Summary

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

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

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

374Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KPS-0373, High dose	Drug	28 weeks	KPS-0373
KPS-0373, Low dose

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
SF-8 (QOL)		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

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

Name	Affiliation	Role
Tatsuro Takei		Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31937586	Derived	Nishizawa M, Onodera O, Hirakawa A, Shimizu Y, Yamada M; Rovatirelin Study Group. Effect of rovatirelin in patients with cerebellar ataxia: two randomised double-blind placebo-controlled phase 3 trials. J Neurol Neurosurg Psychiatry. 2020 Mar;91(3):254-262. doi: 10.1136/jnnp-2019-322168. Epub 2020 Jan 14.

ID	Term
D013132	Spinocerebellar Degenerations
D020754	Spinocerebellar Ataxias

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