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

Japan-First-in Large Scale Observational Study for Non-motor Symptoms and Treatment in Parkinson's Disease Patients.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02073981

Acronym

J-FIRST

Enrollment

1021

Registered

2014-02-28

Start date

2014-03-31

Completion date

2023-06-30

Last updated

2023-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Parkinson Disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Countries

Japan

Outcome results