NCT02073981

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,021

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 28, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
7.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

August 7, 2023

Status Verified

August 1, 2023

Enrollment Period

2.2 years

First QC Date

February 26, 2014

Last Update Submit

August 4, 2023

Conditions

Parkinson Disease

Keywords

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Parkinson Disease

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Parkinson Disease

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Juntendo University Hospital

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2014

First Posted

February 28, 2014

Study Start

March 1, 2014

Primary Completion

May 1, 2016

Study Completion

June 1, 2023

Last Updated

August 7, 2023

Record last verified: 2023-08

Locations

JP(1)