At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 308 enrolled
Drug / intervention
Istradefyllinedrug
Likely dose
Istradefylline 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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Long-Term Safety Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3)
In Brief
A Phase 3 clinical trial evaluating Istradefylline for Parkinson's Disease. Completed, enrolled 308 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2009
Enrollment StartOct 2009
Primary CompletionSep 2011
Study CompletionMar 2012
TodayJul 2026
First PostedAug 12, 2009
Enrollment StartOct 1, 2009
Primary CompletionSep 1, 2011
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 16.9 years ago
Interventions
Istradefyllinedrug
Oral istradefylline (KW-6002) 20 or 40 mg once daily