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

Overview

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.

Full Title of Study: “Japan-First-in Large Scale Observational Study for Non-motor Symptoms and Treatment in Parkinson’s Disease Patients.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2016

Arms, Groups and Cohorts

  • Parkinson Disease

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kyowa Kirin Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor

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