Observational Study for Non-motor Symptoms and Treatment... | NCT02073981

Studies
Observational Study for Non-motor Symptoms and Treatment in Parkinson's Disease Patients

NCT02073981

Sponsor

Kyowa Kirin Co., Ltd.

Status

Completed

Last Update Posted

Aug 7, 2023Actual

Enrollment

1,021Actual

Phase

Not provided

Conditions

Parkinson Disease

Interventions

Not provided

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

Aug 2023

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

Mar 2014

Primary Completion Date

May 2016Actual

Completion Date

Jun 2023Actual

First Submitted Date

Feb 26, 2014

First Submission Date that Met QC Criteria

Feb 26, 2014

First Posted Date

Feb 28, 2014Estimated

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

Aug 4, 2023

Last Update Posted Date

Aug 7, 2023Actual

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

This study is implemented to identify factors having an impact on improvement or exacerbation of non-motor symptoms, to provide information contributing to development of medical care in this field and improvement of patients' QOL, and to clarify the association between the use of istradefylline and non-motor symptoms or QOL.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,021Actual

Label	Type	Description	Intervention Names
Parkinson Disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changing of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	MDS-UPDRS score will be collected from all registrant at each visit and on the last day of survey.	52 weeks
Changing of Parkinson's Disease Questionaire-8 (PDQ-8) score.	PDQ-8 score will be collected from all registrant at each visit and on the last day of survey.	52 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who have wearing off under treatment with levodopa-containing drugs administered at least three times daily
Patients who have at least one non-motor symptom as a complication
Patients at least 20 years of age at the time of consent
Patients who have given written consent
Patients who are receiving outpatient care

Exclusion Criteria:

Patients with dementia or a score of 23 or less on the Mini-Mental State Examination (MMSE)
Patients, in the opinion of the investigator or subinvestigator, having conditions impairing the proper assessment of the MDS-UPDRS or PDQ-8 (e.g., patients who are receiving treatment for malignant tumor)

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

Parkinson Disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Juntendo University Hospital		Bunkyo-ku	Tokyo	113-8431	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