A Phase 3 interventional study of Istradefylline (KW-6002) in Parkinson's Disease, sponsored by Kyowa Kirin, Inc.. Completed at 2 sites in United States. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2024-04-25.
Sponsored by Kyowa Kirin, Inc. · Phase 3, Interventional, and Treatment
To establish the efficacy of 10, 20 and 40 mg/d dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa.
To establish the efficacy of 10, 20 and 40 mg/d dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa. Patients who meet entry criteria will be randomized in a 1 to 1 ratio to either istradefylline 10, 20 or 40 mg or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess efficacy and safety.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 580 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Kyowa Kirin, Inc. is the lead sponsor of 34 studies on the registry; 2 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
To establish the efficacy of 10, 20 and 40 mg/d istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa/carbidopa.
To evaluate the dose-response of 10, 20 and 40 mg/d istradefylline using the primary efficacy outcome variable.
To evaluate the efficacy of 10, 20 and 40 mg/d istradefylline for reducing the total hours of OFF time.
To evaluate the change in total hours of ON time (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia).
To evaluate the change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination score (part III) and/or in Activities of Daily Living (ADL) score (part II).
To evaluate the change in Parkinson's Disease Questionnaire (PDQ-39) and Medical Outcomes Study 36-item Short Form (SF-36).
To evaluate the Patient Global Impression - Improvement scale (PGI-I).
To evaluate change in the Clinical Global Impression - Severity of Illness scale (CGI-S).
To evaluate the safety of 10, 20, and 40 mg/d istradefylline by changes in safety parameters as noted in Section 7.2.4.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Kyowa Kirin, Inc.