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

Parkinson Disease Clinical Trial

— J-FIRST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02073981
• Other study ID #: J-FIRST
• Status: Completed
• Start date: March 2014
• Est. completion date: June 2023

Study information

• Verified date: August 2023
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1021
• Est. completion date: June 2023
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
Japan	Juntendo University Hospital	Bunkyo-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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