A Long-Term, Multicenter, Open-Label, Safety Study With a Flexible Dose Range of KW-6002 as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy

Kyowa Kirin, Inc.1 个研究点分布在 1 个国家开始时间: 2002年8月最近更新: 2024年4月25日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Kyowa Kirin, Inc.
试验地点: 1

研究概览入排标准研究组 & 干预措施研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary objective of this study was to establish the long-term tolerability and safety of istradefylline treatment in subjects with Parkinson's disease treated with levodopa/carbidopa. In addition, treatment response and maintenance of response were assessed.

研究设计

研究类型: Interventional

入排标准

年龄范围: 30 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Eligible subjects were:
•male or female
•at least 30 years of age
•had completed participation in a prior double-blind istradefylline trial
•met United Kingdom's Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and Step 2) for Parkinson's disease and the severity of the Parkinson's disease was defined as Stages 2-4 on the Modified Hoehn and Yahr Scale while in the OFF state
•had been treated with levodopa for at least 1 year
•had been on a stable Parkinson's disease regimen within normal therapeutic ranges including levodopa for at least 4 weeks before Baseline
•were currently taking at least 4 doses of levodopa per day (3 doses per day if at least 2 doses contained slow-release formulation)
•had predictable end-of-dose wearing-off

排除标准

未提供

研究组 & 干预措施

istradefylline

Experimental

干预措施: istradefylline (Drug)

研究者

发起方

Kyowa Kirin, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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