Observational Study for Non-motor Symptoms and Treatment in Parkinson's Disease Patients (J-FIRST)

August 4, 2023 updated by: Kyowa Kirin Co., Ltd.

Japan-First-in Large Scale 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1021

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Juntendo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Parkinson Disease

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Parkinson Disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
52 weeks
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.
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

February 26, 2014

First Submitted That Met QC Criteria

February 26, 2014

First Posted (Estimated)

February 28, 2014

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 4, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J-FIRST

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe