Effectiveness and safety of opicapone in Parkinson's disease patients with motor fluctuations: The OPTIPARK open-label study

Heinz Reichmann, Andrew Lees, José Francisco Rocha, Diogo Magalhães, Patrício Soares-Da-Silva, Csaba Antal Zolnai, Claudius Bartels, Andreas Barth, Kriemhild Barth, Stephan Behrens, Arnfin Bergmann, Ralf Bodenschatz, Rommy Born, Moriz Brandt, Sebastian Brock, Bernd Brockmeier, Christof Brücke, Norbert Brüggemann, Bernhard Bühler, Uwe BungardLukas Cepek, Ilona Csoti, Max Deist, Carl Detlev Reimers, Ulrich Dölle, Sylke Domke, Imanuel Dzialowski, Georg Ebersbach, Heike Eggert, Karla Eggert, Reinhard Ehret, Jana Engel, Urban Fietzek, Anke Friedrich, Michael Fritzinger, Florin Gandor, Klaus Gehring, Stephan Gierer, Stephanie Gierer, Vasil Gjaurov, Doreen Gruber, Özkan Günes, Thomas Haas, Kirsten Hahn, Anna Eszter Haraszti, Rolf Hartmann, Bernhard Haslinger, Eva Heiss, Heinz P. Herbst, Frank Hoffmann, Werner E. Hofmann, Günter Höglinger, Wolfgang Jost, Anna Maria Kavcic, Christoph Kellinghaus, Bertold Klemperer, Fabian Klostermann, Thomas Knoll, Natalia Koleva-Alazeh, Jiri Koschel, Diana Waltraud Kraft-Safavi, Almut Kronenberger, Andrea Kühn, Andreas Kupsch, Thomas Lehnhoff, Peter Laumen, Paul Lingor, Karla Lippmann, Michael Lorrain, Fabian Maass, Siegfried Muhlack, Thomas Müller, Michael Nagel, Stephan Neudecker, Katja Odin, Christian Oehlwein, Hakan Orbasli, Wolfram Von Pannwitz, Heidi Pape, Robert Pfister, Tino Prell, Reinhard Puzich, Daniela Rau, Rene Reese, Gerd Reifschneider, Gernot Reimann, Stefani Ries, Christoph Rieth, Charlotte Rewitzer, Ali Safavi, Alexander B. Schmied, Johannes Schwarz, Wolfgang Schwarz, Joachim Springub, Inga Suttrup Claus, Vera Tadic, Klaus Tiel-Wilck, Lars Tönges, Jens Tröger, Christoph Schrey, Alexander Schulze, Sven Thonke, Tobias Wächter, Achim S. Wannenmacher, Tobias Warnecke, Bettina Wieder, Martin Wimmer, Christian Winkler, Otto Witte, Dirk Woitalla, Samis Zella, Uwe Ziebold, Jane Alty, Reem Amin, Michaela Boca, Stephen Butterworth, Camille Carroll, Gavin Charlesworth, K. Ray Chaudhuri, Rajkumar Chinnadurai, Jemima Collins, Jeremy Stephen Cosgrove, Samantha Cravey, Dinesh Damodaran, Nikolay Dimitrov, Rory Durcan, Simon Ellis, Adbdul Elmarimi, Jonathan Evans, James Fisher, Donald Grosset, Stuart Jamieson, Christopher Kobylecki, Sze Hway Lim, Veronica Lyell, Biju Mohamed, Sophie Molloy, Nicola Pavese, Dominic Paviour, Madeleine Purchas, Khalid Rashed, Christopher Rickards, Tabish Saifee, Gillian Sare, Christine Schofield, Naveen Setty, Jagdish Sharma, Ray Sheridan, Siew Lee Shu, Monty Silverdale, Rani Sophia, Sarah Statton, Malcolm Steiger, Christopher Thomas, Richard Walker, Tai Yen Foung

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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 ± SD change from baseline: - 3.0 ± 4.6, p < 0.0001) and motor scores during ON (- 4.6 ± 8.1, p < 0.0001). The mean ± SD improvements of - 3.4 ± 12.8 points for PDQ-8 and -6.8 ± 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).

Original languageEnglish
Article number9
JournalTranslational Neurodegeneration
Volume9
Issue number1
DOIs
StatePublished - 4 Mar 2020

Keywords

  • Levodopa
  • Motor fluctuations
  • Open-label
  • Opicapone
  • Parkinson's disease

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