Clinical efficacy of istradefylline (KW-6002) in Parkinson's disease: a randomized, controlled study

Movement Disorders : Official Journal of the Movement Disorder Society
Yoshikuni MizunoJapanese Istradefylline Study Group

Abstract

The objectives of this study were to evaluate the efficacy of istradefylline at an oral dose of 20 mg or 40 mg once daily for 12 weeks in Parkinson's disease (PD) patients with motor complications on levodopa therapy based on the change in the daily OFF time compared with placebo and to assess the safety at these doses. A total of 363 subjects were randomly assigned to receive 20 mg/day istradefylline (n = 119), 40 mg/day istradefylline (n = 125), or placebo (n = 119). The primary outcome variable was the change from baseline at endpoint in daily OFF time based on patients' ON/OFF diaries. At endpoint, the daily OFF time reduced from baseline by 1.31 hours for 20 mg/day istradefylline (P = 0.013 as compared to the placebo), 1.58 hours for 40 mg/day istradefylline (P < 0.001), and 0.66 hours for placebo; istradefylline significantly reduced the daily OFF time compared with placebo. The UPDRS Part III subscale score (ON state) reduced by 5.7 at endpoint in both istradefylline groups and 3.7 in the placebo group (P = 0.006 for 20 mg/day and P = 0.006 for 40 mg/day group as compared with placebo). The most commonly reported drug-related treatment emergent adverse event (TEAE) was dyskinesia, which occurred in 2.5% (3/119) of subjec...Continue Reading

References

Jul 1, 1990·Trends in Neurosciences·M R DeLong
Mar 27, 2003·Trends in Molecular Medicine·Ari Barzilai, Eldad Melamed
Apr 1, 2003·Annals of Neurology·Olivier RascolJean-Louis Montastruc
Apr 1, 2003·Annals of Neurology·Stephane Hunot, E C Hirsch
Jul 9, 2003·Annals of the New York Academy of Sciences·Stanley Fahn
Aug 13, 2003·Neurology·Robert A HauserUNKNOWN Istradefylline US-001 Study Group
Sep 16, 2003·Neuron·William Dauer, Serge Przedborski
Mar 23, 2004·Brain : a Journal of Neurology·Frédéric CalonThérèse Di Paolo
Jun 8, 2004·Current Opinion in Neurology·Ubaldo Bonuccelli
Sep 25, 2004·Movement Disorders : Official Journal of the Movement Disorder Society·Robert A HauserPhilippe Lehert
Jul 12, 2005·Expert Opinion on Investigational Drugs·Peter Jenner
Jul 11, 2006·Movement Disorders : Official Journal of the Movement Disorder Society·Plamen GatevThomas Wichmann
Oct 4, 2008·Movement Disorders : Official Journal of the Movement Disorder Society·Robert A HauserUNKNOWN Istradefylline 6002-US-013 Study Group

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Citations

Jul 3, 2013·Naunyn-Schmiedeberg's Archives of Pharmacology·Mayumi SakiTomoyuki Kanda
May 16, 2012·Current Neurology and Neuroscience Reports·Patrick Hickey, Mark Stacy
May 24, 2013·Drugs·Rosselle Dungo, Emma D Deeks
Oct 1, 2011·Neuropsychopharmacology : Official Publication of the American College of Neuropsychopharmacology·Yoland SmithMahlon R DeLong
May 3, 2011·Nature Reviews. Drug Discovery·Wassilios G MeissnerErwan Bezard
Aug 3, 2012·Neurology·Ronald B PostumaBinit Shah
Dec 7, 2013·Neurotherapeutics : the Journal of the American Society for Experimental NeuroTherapeutics·Albert Y Hung, Michael A Schwarzschild
Oct 23, 2012·Journal of the Neurological Sciences·Wanqiang ChenHaiping Wei
Jun 20, 2014·Purinergic Signalling·Izaskun Villar-MenéndezMarta Barrachina
Jul 4, 2012·Parkinson's Disease·Micaela MorelliRobert A Hauser
Nov 9, 2011·The International Journal of Neuroscience·Robert A Hauser
Dec 3, 2015·Expert Review of Neurotherapeutics·Ruxandra Julia Vorovenci, Angelo Antonini
Dec 18, 2013·Expert Review of Neurotherapeutics·Adolfo Ramirez-Zamora, Eric Molho
Mar 29, 2014·Expert Opinion on Pharmacotherapy·Santiago Perez-Lloret, Marcelo Merello
Sep 22, 2015·Expert Review of Neurotherapeutics·Roongroj BhidayasiriWerner Poewe
Dec 14, 2011·Expert Opinion on Pharmacotherapy·Ariane Park, Mark Stacy
Feb 14, 2015·Expert Opinion on Drug Safety·Thomas Müller
Dec 9, 2014·Expert Opinion on Drug Safety·Manuela Pilleri, Angelo Antonini
Apr 29, 2015·Proceedings of the National Academy of Sciences of the United States of America·Nikhil M UrsMarc G Caron
Mar 12, 2015·Internal Medicine·Keita Matsuura, Hidekazu Tomimoto
Feb 22, 2011·Expert Opinion on Drug Metabolism & Toxicology·Nikoletta SzabóLászló Vécsei
Feb 16, 2015·Cellular and Molecular Life Sciences : CMLS·Flavia NiccoliniMarios Politis
Mar 11, 2016·Expert Opinion on Biological Therapy·Zsófia MajláthLászló Vécsei
Apr 27, 2017·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Jocelyn StockwellFrancisco S Cayabyab
Jul 28, 2017·Chinese Medical Journal·Juan-Juan Du, Sheng-Di Chen
Mar 24, 2018·Movement Disorders : Official Journal of the Movement Disorder Society·Susan H FoxUNKNOWN Movement Disorder Society Evidence-Based Medicine Committee
Dec 23, 2017·Scientific Reports·Wataru SakoRyuji Kaji
Dec 12, 2012·Movement Disorders : Official Journal of the Movement Disorder Society·Lorraine V KaliaSusan H Fox
Sep 21, 2018·Expert Opinion on Pharmacotherapy·Margherita TortiFabrizio Stocchi
Nov 10, 2018·Expert Opinion on Pharmacotherapy·Nataša Dragašević-MiškovićVladimir S Kostić
May 25, 2012·Synapse·Masahiro MishinaKiichi Ishiwata
May 18, 2013·Amyotrophic Lateral Sclerosis & Frontotemporal Degeneration·Fabrizio VincenziKatia Varani
Sep 17, 2013·Acta Neurologica Scandinavica·I CasettaK Varani

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