A Phase 3 interventional study of Istradefylline in Parkinson's Disease, sponsored by Kyowa Kirin Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2012-08-31.
Sponsored by Kyowa Kirin Co., Ltd. · Phase 3, Interventional, and Treatment
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 308 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Kyowa Kirin Co., Ltd. is the lead sponsor of 155 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Istradefylline
Oral istradefylline (KW-6002) 20 or 40 mg once daily
Also known as: KW-6002
Adverse events
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)
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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Kyowa Kirin Co., Ltd.