A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa
Placebo-Controlled , Double-Blind , Exploratory Study of KW-6002(Istradefylline) in the Treatment of Parkinson's Disease. [Adjunctive Therapy to Levodopa]
Sponsor: Kyowa Kirin Co., Ltd.
Listed as NCT00199355, this PHASE2 trial focuses on Parkinson's Disease and remains completed. Sponsored by Kyowa Kirin Co., Ltd., it has been updated 8 times since 2005, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)To establish the efficacy of 20 mg/d and 40mg/d doses 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 1:1:1 ratio to double blind treatment with oral doses of 20 or 40mg/d istradefylline or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline.
To establish the efficacy of 20 mg/d and 40mg/d doses 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 1:1:1 ratio to double blind treatment with oral doses of 20 or 40mg/d istradefylline or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline.
Status Flow
Change History
8 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE2
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Sep 2024 — Present [monthly]
Completed PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE2
-
Aug 2019 — Jan 2021 [monthly]
Completed PHASE2
▶ Show 3 earlier versions
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Jun 2018 — Aug 2019 [monthly]
Completed PHASE2
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Feb 2017 — Jun 2018 [monthly]
Completed PHASE2
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE2
First recorded
Apr 2005
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Kyowa Kirin Co., Ltd.
For direct contact, visit the study record on ClinicalTrials.gov .