Parkinson'
Conditions
Interventions
In this research, the duration of evaluation will be 12 weeks. Treatment with istradefylline will be started at a dose of 20 mg administered once daily. The dose of istradefylline will be increased t
Sponsors
Juntendo University Shizuoka Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Wearing-off phenomena in Parkinson's disease currently treated with levodopa-containing products 2)Gait disorders with freezing of gait due to Parkinson's disease 3)At a stage of <=IV according to the modified Hoehn and Yahr scale (ON state) 4)Aged 20 years or older at the time of consent 5)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Dementia or a score of <=23 on the Mini-Mental State Examination (MMSE) 2)Gait disturbance due to causes other than the underlying disease 3)Severe dyskinesia as assessed by the investigator or subinvestigator 4)Current treatment with istradefylline 5)Moderate to severe hepatic disorder or current treatment with a strong inhibitor of CYP3A4 6)Ongoing treatment with deep brain stimulation (DBS) and a condition requiring stimulation 7)Lactating, pregnant, or possibly pregnant women 8)Other conditions judged by the investigator or subinvestigator to be unsuitable for participation in the research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the total gait-related score of the MDS-UPDRS Part III before at Week 0 and after administration of istradefylline at Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the total score of each MDS-UPDRS part II (gait-related scores), New-FOG-Q, FOG-Q and PDQ-8 before and after administration of istradefylline, Gait analysis by a portable gait device | — |
Countries
Japan
Contacts
Public ContactYasuyuki Okuma
Juntendo University Shizuoka Hospital Neurology
Outcome results
None listed