학술논문
Effectiveness and safety of opicapone in Parkinson's disease patients with motor fluctuations: the OPTIPARK open-label study
Document Type
Report
Author
Reichmann, Heinz; Lees, Andrew; Rocha, José-Francisco; Magalhães, Diogo; Soares-da-Silva, Patrício; Zolnai, Csaba Antal; Bartels, Claudius; Barth, Andreas; Barth, Kriemhild; Behrens, Stephan; Bergmann, Arnfin; Bodenschatz, Ralf; Born, Rommy; Brandt, Moriz; Brock, Sebastian; Brockmeier, Bernd; Brücke, Christof; Brüggemann, Norbert; Bühler, Bernhard; Bungard, Uwe; Cepek, Lukas; Csoti, Ilona; Deist, Max; Reimers, Carl Detlev; Dölle, Ulrich; Domke, Sylke; Dzialowski, Imanuel; Ebersbach, Georg; Eggert, Heike; Eggert, Karla; Ehret, Reinhard; Engel, Jana; Fietzek, Urban; Friedrich, Anke; Fritzinger, Michael; Gandor, Florin; Gehring, Klaus; Gierer, Stephan; Gierer, Stephanie; Gjaurov, Vasil; Gruber, Doreen; Günes, üzkan; Haas, Thomas; Hahn, Kirsten; Haraszti, Anna Eszter; Hartmann, Rolf; Haslinger, Bernhard; Heiss, Eva; Herbst, Heinz P.; Hoffmann, Frank; Hofmann, Werner E.; Höglinger, Günter; Jost, Wolfgang; Kavcic, Anna-Maria; Kellinghaus, Christoph; Klemperer, Bertold; Klostermann, Fabian; Knoll, Thomas; Koleva-Alazeh, Natalia; Koschel, Jiri; Kraft-Safavi, Diana Waltraud; Kronenberger, Almut; Kühn, Andrea; Kupsch, Andreas; Lehnhoff, Thomas; Laumen, Peter; Lingor, Paul; Lippmann, Karla; Lorrain, Michael; Maass, Fabian; Muhlack, Siegfried; Müller, Thomas; Nagel, Michael; Neudecker, Stephan; Odin, Katja; Oehlwein, Christian; Orbasli, Hakan; von Pannwitz, Wolfram; Pape, Heidi; Pfister, Robert; Prell, Tino; Puzich, Reinhard; Rau, Daniela; Reese, Rene; Reifschneider, Gerd; Reimann, Gernot; Ries, Stefani; Rieth, Christoph; Rewitzer, Charlotte; Safavi, Ali; Schmied, Alexander B.; Schwarz, Johannes; Schwarz, Wolfgang; Springub, Joachim; Claus, Inga Suttrup; Tadic, Vera; Tiel-Wilck, Klaus; Tönges, Lars; Tröger, Jens; Schrey, Christoph; Schulze, Alexander; Thonke, Sven; Wächter, Tobias; Wannenmacher, Achim S.; Warnecke, Tobias; Wieder, Bettina; Wimmer, Martin; Winkler, Christian; Witte, Otto; Woitalla, Dirk; Zella, Samis; Ziebold, Uwe; Alty, Jane; Amin, Reem; Boca, Michaela; Butterworth, Stephen; Carroll, Camille; Charlesworth, Gavin; Chaudhuri, K. Ray; Chinnadurai, Rajkumar; Collins, Jemima; Cosgrove, Jeremy Stephen; Cravey, Samantha; Damodaran, Dinesh; Dimitrov, Nikolay; Durcan, Rory; Ellis, Simon; Elmarimi, Adbdul; Evans, Jonathan; Fisher, James; Grosset, Donald; Jamieson, Stuart; Kobylecki, Christopher; Lim, Sze Hway; Lyell, Veronica; Mohamed, Biju; Molloy, Sophie; Pavese, Nicola; Paviour, Dominic; Purchas, Madeleine; Rashed, Khalid; Rickards, Christopher; Saifee, Tabish; Sare, Gillian; Schofield, Christine; Setty, Naveen; Sharma, Jagdish; Sheridan, Ray; Shu, Siew Lee; Silverdale, Monty; Sophia, Rani; Statton, Sarah; Steiger, Malcolm; Thomas, Christopher; Walker, Richard; Foung, Tai Yen
Source
Translational Neurodegeneration. March 4, 2020, Vol. 9 Issue 1
Subject
Language
English
Abstract
Background The efficacy and safety of opicapone, a once-daily catechol-O-methyltransferase inhibitor, have been established in two large randomized, placebo-controlled, multinational pivotal trials. Still, clinical evidence from routine practice is needed to complement the data from the pivotal trials. Methods OPTIPARK (NCT02847442) was a prospective, open-label, single-arm trial conducted in Germany and the UK under clinical practice conditions. Patients with Parkinson's disease and motor fluctuations were treated with opicapone 50 mg for 3 (Germany) or 6 (UK) months in addition to their current levodopa and other antiparkinsonian treatments. The primary endpoint was the Clinician's Global Impression of Change (CGI-C) after 3 months. Secondary assessments included Patient Global Impressions of Change (PGI-C), the Unified Parkinson's Disease Rating Scale (UPDRS), Parkinson's Disease Questionnaire (PDQ-8), and the Non-Motor Symptoms Scale (NMSS). Safety assessments included evaluation of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). Results Of the 506 patients enrolled, 495 (97.8%) took at least one dose of opicapone. Of these, 393 (79.4%) patients completed 3 months of treatment. Overall, 71.3 and 76.9% of patients experienced any improvement on CGI-C and PGI-C after 3 months, respectively (full analysis set). At 6 months, for UK subgroup only (n = 95), 85.3% of patients were judged by investigators as improved since commencing treatment. UPDRS scores at 3 months showed statistically significant improvements in activities of daily living during OFF (mean [+ or -] SD change from baseline: - 3.0 [+ or -] 4.6, p < 0.0001) and motor scores during ON (- 4.6 [+ or -] 8.1, p < 0.0001). The mean [+ or -] SD improvements of - 3.4 [+ or -] 12.8 points for PDQ-8 and -6.8 [+ or -] 19.7 points for NMSS were statistically significant versus baseline (both p < 0.0001). Most of TEAEs (94.8% of events) were of mild or moderate intensity. TEAEs considered to be at least possibly related to opicapone were reported for 45.1% of patients, with dyskinesia (11.5%) and dry mouth (6.5%) being the most frequently reported. Serious TEAEs considered at least possibly related to opicapone were reported for 1.4% of patients. Conclusions Opicapone 50 mg was effective and generally well-tolerated in PD patients with motor fluctuations treated in clinical practice. Trial registration Registered in July 2016 at clinicaltrials.gov (NCT02847442). Keywords: Levodopa, Motor fluctuations, Open-label, Opicapone, Parkinson's disease
Author(s): Heinz Reichmann[sup.1], Andrew Lees[sup.2], José-Francisco Rocha[sup.3], Diogo Magalhães[sup.3,5], Patrício Soares-da-Silva[sup.4,5,6], Csaba Antal Zolnai, Claudius Bartels, Andreas Barth, Kriemhild Barth, Stephan Behrens, Arnfin Bergmann, Ralf Bodenschatz, Rommy Born, Moriz Brandt, [...]
Author(s): Heinz Reichmann[sup.1], Andrew Lees[sup.2], José-Francisco Rocha[sup.3], Diogo Magalhães[sup.3,5], Patrício Soares-da-Silva[sup.4,5,6], Csaba Antal Zolnai, Claudius Bartels, Andreas Barth, Kriemhild Barth, Stephan Behrens, Arnfin Bergmann, Ralf Bodenschatz, Rommy Born, Moriz Brandt, [...]