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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Juntendo University Hospital

Bunkyo-ku, Tokyo, 113-8431, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

Changing of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

Time frame: 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.

Time frame: 52 weeks

PDQ-8 score will be collected from all registrant at each visit and on the last day of survey.

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

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

Acronym: J-FIRST

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2023
First posted: Feb 28, 2014
Registry last updated: Aug 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed