Tozadenant (SYN115) in patients with Parkinson's disease who have motor fluctuations on levodopa: A phase 2b, double-blind, randomised trial

The Lancet Neurology

Volumn 13, Issue 8, 2014, Pages 767-776

  Hauser, Robert A ^a   Olanow, C Warren ^b   Kieburtz, Karl D ^c   Pourcher, Emmanuelle ^d   Docu Axelerad, Any ^e   Lew, Mark ^f   Kozyolkin, Olexandr ^g   Neale, Ann ^h   Resburg, Chris ^h   Meya, Uwe ^h   Kenney, Christopher ^h   Bandak, Stephen ^h  

^a UNIVERSITY OF SOUTH FLORIDA   (United States)

^b MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF ROCHESTER SCHOOL OF MEDICINE AND DENTISTRY   (United States)

^d UNIVERSITÉ LAVAL   (Canada)

^e OVIDIUS UNIVERSITY   (Romania)

^f UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^g ZAPORIZHZHIA STATE MEDICAL UNIVERSITY   (Ukraine)

^h Biotie Therapies South San Francisco ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CREATINE KINASE; PLACEBO; TOZADENANT; LEVODOPA;

ADULT; ARTICLE; BACKACHE; CONSTIPATION; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; DISEASE EXACERBATION; DIZZINESS; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG WITHDRAWAL; DYSKINESIA; FALLING; FEMALE; FLUSHING; HUMAN; INSOMNIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; PARALLEL DESIGN; PARKINSON DISEASE; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SLEEP DISORDER; TREATMENT DURATION; TREATMENT OUTCOME; URINARY TRACT INFECTION; ACUTE HEART INFARCTION; ACUTE KIDNEY FAILURE; BECK ANXIETY INVENTORY; BECK DEPRESSION INVENTORY; DISEASE DURATION; DRUG TOLERABILITY; HOT FLUSH; INTENTION TO TREAT ANALYSIS; MINI MENTAL STATE EXAMINATION; MOTOR DYSFUNCTION; UNIFIED PARKINSON DISEASE RATING SCALE;

ADENOSINE A2 RECEPTOR ANTAGONISTS; AGED; ANTIPARKINSON AGENTS; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; DYSKINESIA, DRUG-INDUCED; FEMALE; HUMANS; INTERNATIONALITY; LEVODOPA; MALE; MIDDLE AGED; PARKINSON DISEASE;

EID: 84907030797     PISSN: 14744422     EISSN: 14744465     Source Type: Journal    
DOI: 10.1016/S1474-4422(14)70148-6     Document Type: Article

References (26)

1. Hettinger BD, Lee A, Linden J, Rosin DL Ultrastructural localization of adenosine A2A receptors suggests multiple cellular sites for modulation of GABAergic neurons in rat striatum. J Comp Neurol 2001, 431:331-346.
2. Hauser RA, Hubble JP, Truong DD Randomized trial of the adenosine A2A receptor antagonist istradefylline in advanced PD. Neurology 2003, 61:297-303. Istradefylline US-001 Study Group.
3. LeWitt PA, Guttman M, Tetrud JW, et al. Adenosine A2A receptor antagonist istradefylline (KW-6002) reduces "off" time in Parkinson's disease: a double-blind, randomized, multicenter clinical trial (6002-US-005). Ann Neurol 2008, 63:295-302.
4. Stacy M, Silver D, Mendis T, et al. A 12-week, placebo-controlled study (6002-US-006) of istradefylline in Parkinson disease. Neurology 2008, 70:2233-2240.
5. Hauser RA, Cantillon M, Pourcher E, et al. Preladenant in patients with Parkinson's disease and motor fluctuations: a phase 2, double-blind, randomised trial. Lancet Neurol 2011, 10:221-229.
6. Merck provides update on phase III clinical program for preladenant, the company's investigational Parkinson's disease medicine Merck, (accessed Feb 26, 2014). http://www.businesswire.com/news/home/20130523006358/en/Merck-Update-Phase-III-Clinical-Program-Preladenant.
7. Hauser RA, Shulman LM, Trugman JM, et al. Study of istradefylline in patients with Parkinson's disease on levodopa with motor fluctuations. Mov Disord 2008, 23:2177-2185.
8. Pourcher E, Fernandez HH, Stacy M, Mori A, Ballerini R, Chaikin P Istradefylline for Parkinson's disease patients experiencing motor fluctuations: results of the KW-6002-US-018 study. Parkinsonism Relat Disord 2012, 18:178-184.
9. Black KJ, Koller JM, Campbell MC, Gusnard DA, Bandak SI Quantification of indirect pathway inhibition by the adenosine A2a antagonist SYN115 in Parkinson disease. J Neurosci 2010, 30:16284-16292.
10. Hauser RA, Friedlander J, Zesiewicz TA, et al. A home diary to assess functional status in patients with Parkinson's disease with motor fluctuations and dyskinesia. Clin Neuropharmacol 2000, 23:75-81.
11. Fahn S, Elton RL The Unified Parkinson's Disease Rating Scale. Recent developments in Parkinson's disease 1987, 153-163. Members of the UPDRS Development Committee, Macmillan Healthcare Information, New York. S. Fahn, C.D. Marsden, D.B. Calne, M. Goldstein (Eds.).
12. Peto V, Jenkinson C, Fitzpatrick R PDQ39: a review of the development, validation and application of a Parkinson's disease quality of life questionnaire and its associated measures. J Neurol 1998, 245(suppl 1):S10-S14.
13. Beck AT, Steer RA, Brown GK Manual for the Beck Depression Inventory-II 1996, Psychological Corporation, San Antonio.
14. Beck AT, Epstein N, Brown G, Steer RA An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psych 1988, 56:893-897.
15. Hauser RA, Auinger P Determination of minimal clinically important change in early and advanced Parkinson's disease. Mov Disord 2011, 26:813-818. Parkinson Study Group.
16. Stowe R, Ives N, Clarke CE, et al. Evaluation of the efficacy and safety of adjuvant treatment to levodopa therapy in Parkinson's disease patients with motor complications. Cochrane Database Syst Rev 2010, 7. CD007166.
17. Brooks DJ, Warrington S, Tendolkar A, Cutler DL, Hunter J Positron emission tomography (PET) study of preladenant in healthy male subjects. Mov Disord 2009, 24(suppl 1):S257.
18. Morelli M, Blandini F, Simola N, Hauser RA A2A receptor antagonism and dyskinesia in Parkinson's disease. Parkinsons Dis 2012, 2012:489853.
19. Bara-Jimenez W, Sherzai A, Dimitrova T, et al. Adenosine A2A receptor antagonist treatment of Parkinson's disease. Neurology 2003, 61:293-296.
20. Bibbiani F, Oh JD, Petzer JP, et al. A2A antagonist prevents dopamine agonist-induced motor complications in animal models of Parkinson's disease. Exp Neurol 2003, 184:285-294.
21. Chen W, Wang H, Wei H, Gu S, Wei H Istradefylline, an adenosine A2A receptor antagonist, for patients with Parkinson's disease: a meta-analysis. J Neurol Sci 2013, 324:21-28.
22. Cutler DL, Tendolkar A, Grachev ID Safety, tolerability and pharmacokinetics after single and multiple doses of preladenant (SCH420814) administered in healthy subjects. J Clin Pharm Ther 2012, 37:578-587.
23. Factor SA, Wolski K, Togasaki DM, et al. Long-term safety and efficacy of preladenant in subjects with fluctuating Parkinson's disease. Mov Disord 2013, 28:817-820.
24. Kyowa Hakko receives not approvable letter from FDA for istradefylline (KW-6002) PR Newswire Services, (accessed March 21, 2014). http://www.prnewswire.com/news-releases/kyowa-hakko-receives-not-approvable-letter-from-fda-for-istradefylline-kw-6002-57334117.html.
25. Mizuno Y, Hasegawa K, Kondo T, Kuno S, Yamamoto M Clinical efficacy of istradefylline (KW-6002) in Parkinson's disease: a randomized, controlled study. Mov Disord 2010, 25:1437-1443.
26. Kyowa Hakko Kirin initiates a global phase 3 trial of istradefylline (KW-6002) for Parkinson's disease Kyowa Hakko Kirin, (accessed March 19, 2014). http://www.kyowa-kirin.com/news_releases/2013/e20131121_01.html.