Observational Study for Non-motor Symptoms and Treatment in Parkinson's Disease Patients
Completed
- Conditions
- Parkinson Disease
- Registration Number
- NCT02073981
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1021
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Juntendo University Hospital
šÆšµBunkyo-ku, Tokyo, Japan