Parkinson's Disease
Conditions
Keywords
Parkinson's disease, levodopa, end of dose wearing off, OFF time
Brief summary
Patients with Parkinson's disease who completed the prior double-blind study 6002-009 are eligible to enter into this long-term study. The purpose of this study is to evaluate the safety and efficacy of KW-6002 administered long-term in patients with advanced Parkinson's disease treated with levodopa.
Interventions
DRUGIstradefylline
Oral istradefylline (KW-6002) 20 or 40 mg once daily
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be willing and able to give written informed consent 2. Completion of the study 6002-009
Exclusion criteria
1. Mini-mental status examination score of 23 or less 2. Less than 70% of compliance in the study 6002-009 3. Emergency deviation in the study 6002-009 4. Pregnant females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Reducing the mean total hours of awake time per day spent in the OFF state | — |
| Reducing the mean percentage of awake time per day spent in the OFF state | — |
| Mean change in the total hours and the percentage of awake time per day spent in the ON state (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia) | — |
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) | — |
| Change in the Clinical Global Impression - Improvement scale (CGI-I) | — |
Countries
Japan
Outcome results
None listed