A Clinical Study of KDT-3594 in Patients With Early Parki... | NCT03845387

Studies
A Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease.

NCT03845387

Sponsor

Kissei Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Feb 17, 2021Actual

Enrollment

74Actual

Phase

Phase 2

Conditions

Parkinson Disease

Interventions

KDT-3594
Pramipexole

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

Feb 2021

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

Feb 26, 2019Actual

Primary Completion Date

Feb 21, 2020Actual

Completion Date

Feb 21, 2020Actual

First Submitted Date

Feb 15, 2019

First Submission Date that Met QC Criteria

Feb 15, 2019

First Posted Date

Feb 19, 2019Actual

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

Feb 16, 2021

Last Update Posted Date

Feb 17, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

Objective of this study is to investigate the efficacy, safety and pharmacokinetics of KDT-3594 in patients with early Parkinson's disease without a concomitant medication of L-dopa.

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

74Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
KDT-3594	Experimental		Drug: KDT-3594
Pramipexole	Other	Reference drug	Drug: Pramipexole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KDT-3594	Drug	oral administration, dose titration	KDT-3594
Pramipexole

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score	Change from baseline (Week 0) in MDS-UPDRS total score	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in Parkinson's Disease Questionnaire-39 (PDQ-39) score	Change from baseline (Week 0) in PDQ-39 summary index score	12 weeks
Change in Parkinson's Disease Sleep Scale-2 (PDSS-2) score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Japanese patients
Patients who are diagnosed with Parkinson's disease according to UK Parkinson's Disease society brain bank clinical diagnostic criteria
Patients with Parkinson's disease in Stages 1 to 3 on the Modified Hoehn and Yahr Scale

Exclusion Criteria:

Patients who are suspected any parkinsonism except for idiopathic Parkinson's disease
Patients who underwent neurosurgical treatment (stereotaxic destruction, deep brain stimulation etc.) for PD, or patients for whom surgical treatment is scheduled during the study
Patients with a complication of obvious dementia, or patients with Mini-Mental State Examination (MMSE) score < 24 points

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Naomi Koshihara	Kissei Pharmaceutical Co., Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Multiple Locations			Japan

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077487	Pramipexole

Ancestor Terms

ID	Term
D052160	Benzothiazoles
D013844	Thiazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided