This trial is active, not recruiting.

Condition parkinson disease
Sponsor Kyowa Hakko Kirin Company, Limited
Start date March 2014
End date August 2016
Trial size 1000 participants
Trial identifier NCT02073981, J-FIRST


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Changing of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
time frame: 52 weeks
Changing of Parkinson's Disease Questionaire-8 (PDQ-8) score.
time frame: 52 weeks

Eligibility Criteria

Male or female participants at least 20 years old.

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)

Additional Information

Official title Japan-First-in Large Scale Observational Study for Non-motor Symptoms and Treatment in Parkinson's Disease Patients.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Kyowa Hakko Kirin Company, Limited.