Parkinson'
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed with Parkinson's disease by the British Brain Bank Clinical Criteria 2) Patients with H & Y classification 2-4 degrees 3) Patients aged between 20 and 85 at the time of consent 4) Patients who have been treated with levodopa for 6 months or more by the time consent is obtained and who have a wearing-off phenomenon 5) Patients receiving levodopa therapy at a fixed dosage and administration (3 times a day or more) from the start of observation 6) Patients who have been receiving a certain dosage and administration from the start of observation when using entacapone and opicapone together 7) Patients receiving a certain dosage and administration from 14 days before the start of observation when using a combination of dopamine agonist, amantadine, anticholinergic drug, droxidopa, istradefylline or zonisamide 8) Patients who have given written consent to participate in this study
Exclusion criteria
Exclusion criteria: 1) Patients with serious physical symptoms other than Parkinson's disease (cardiac / liver / renal dysfunction, hematopoietic disorders, etc.) 2) Viral hepatitis: HBsAg positive or HCV antibody positive 3) Women who are pregnant or may become pregnant 4) Patients with drug addiction / alcohol dependence 5) Patients with serious psychiatric symptoms (confusion, hallucinations, delusions, abnormal behavior, etc.) within 3 months before obtaining the consent form 6) In addition, when the principal investigator or the research coordinator judges that participation in this research is not appropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average daily off-time changes from baseline (7-day pre-evaluation mean during treatment-baseline 7-day pre-evaluation mean) | — |
Secondary
| Measure | Time frame |
|---|---|
| Average daily off-time (average value for 7 days before each evaluation), UPDRS part II total score, UPDRS part III total score, PDQ-39summary Index and domain score | — |
Countries
Japan
Contacts
Osaka Toneyama Medical Center Neurology