Study of istradefylline in patients with Parkinson's disease on levodopa with motor fluctuations |
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| Authors: | Robert A Hauser MD Lisa M Shulman MD Joel M Trugman MD John W Roberts MD Akihisa Mori PhD Rocco Ballerini PhD Neil M Sussman MD |
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| Institution: | 1. Departments of Neurology, Molecular Pharmacology, and Physiology, University of South Florida, Tampa, Florida, USA;2. Department of Neurology, University of Maryland School of Medicine, Baltimore, Maryland, USA;3. Department of Neurology, University of Virginia, Charlottesville, Virginia, USA;4. Section of Neurology, Virginia Mason Medical Center, Seattle, Washington, USA;5. Kyowa Hakko Kogyo Co., Ltd. Tokyo, Japan;6. Kyowa Pharmaceutical, Inc., Princeton, New Jersey, USA |
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| Abstract: | The objective of this study was to evaluate the efficacy, safety, and tolerability of istradefylline 20 mg once daily versus placebo as an adjunct to levodopa in subjects with Parkinson's disease (PD) who have motor fluctuations. Istradefylline (KW‐6002) is an adenosine A2A receptor antagonist that in primate models of PD improves motor function without causing or worsening dyskinesia. This 12‐week, multicenter, double‐blind, placebo‐controlled, randomized, Phase 3 study of istradefylline was conducted in subjects experiencing an average daily OFF time of at least 3 hours (116 randomized to istradefylline; 115 to placebo). All were on stable levodopa regimens; 90% were also on stable regimens of other anti‐Parkinson's medications. Istradefylline‐treated subjects had significant placebo‐corrected reductions in daily OFF time from baseline to endpoint: 4.6% (P = 0.03) and 0.7 hours (P = 0.03). For ON time with troublesome dyskinesia, the changes between istradefylline and placebo were not significant. Istradefylline was well tolerated, with 6 (5.2%) istradefylline‐treated and 7 (6.1%) placebo‐treated subjects withdrawing from the study because of adverse events. Dyskinesia, lightheadedness, tremor, constipation, and weight decrease were reported more often with istradefylline than placebo. We conclude that istradefylline is well tolerated and significantly reduces OFF time as an adjunct to levodopa in PD subjects with motor fluctuations. © 2008 Movement Disorder Society |
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| Keywords: | istradefylline KW‐6002 Parkinson's disease treatment motor fluctuations off time |
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