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 Bungard; Lukas 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

doi:10.1186/s40035-020-00187-1

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).

Originalsprache	Englisch
Aufsatznummer	9
Fachzeitschrift	Translational Neurodegeneration
Jahrgang	9
Ausgabenummer	1
DOIs	https://doi.org/10.1186/s40035-020-00187-1
Publikationsstatus	Veröffentlicht - 4 März 2020

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Reichmann, H., Lees, A., Rocha, J. F., Magalhães, D., Soares-Da-Silva, P., Zolnai, C. A., Bartels, C., Barth, A., Barth, K., Behrens, S., Bergmann, A., Bodenschatz, R., Born, R., Brandt, M., Brock, S., Brockmeier, B., Brücke, C., Brüggemann, N., Bühler, B., ... Foung, T. Y. (2020). Effectiveness and safety of opicapone in Parkinson's disease patients with motor fluctuations: The OPTIPARK open-label study. Translational Neurodegeneration, 9(1), Artikel 9. https://doi.org/10.1186/s40035-020-00187-1

@article{19e68acb8f5e4c45a00fb6d349d1da3c,

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

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).",

keywords = "Levodopa, Motor fluctuations, Open-label, Opicapone, Parkinson's disease",

author = "Heinz Reichmann and Andrew Lees and Rocha, {Jos{\'e} Francisco} and Diogo Magalh{\~a}es and Patr{\'i}cio Soares-Da-Silva and Zolnai, {Csaba Antal} and Claudius Bartels and Andreas Barth and Kriemhild Barth and Stephan Behrens and Arnfin Bergmann and Ralf Bodenschatz and Rommy Born and Moriz Brandt and Sebastian Brock and Bernd Brockmeier and Christof Br{\"u}cke and Norbert Br{\"u}ggemann and Bernhard B{\"u}hler and Uwe Bungard and Lukas Cepek and Ilona Csoti and Max Deist and Reimers, {Carl Detlev} and Ulrich D{\"o}lle and Sylke Domke and Imanuel Dzialowski and Georg Ebersbach and Heike Eggert and Karla Eggert and Reinhard Ehret and Jana Engel and Urban Fietzek and Anke Friedrich and Michael Fritzinger and Florin Gandor and Klaus Gehring and Stephan Gierer and Stephanie Gierer and Vasil Gjaurov and Doreen Gruber and {\"O}zkan G{\"u}nes and Thomas Haas and Kirsten Hahn and Haraszti, {Anna Eszter} and Rolf Hartmann and Bernhard Haslinger and Eva Heiss and Herbst, {Heinz P.} and Frank Hoffmann and Hofmann, {Werner E.} and G{\"u}nter H{\"o}glinger and Wolfgang Jost and Kavcic, {Anna Maria} and Christoph Kellinghaus and Bertold Klemperer and Fabian Klostermann and Thomas Knoll and Natalia Koleva-Alazeh and Jiri Koschel and Kraft-Safavi, {Diana Waltraud} and Almut Kronenberger and Andrea K{\"u}hn and Andreas Kupsch and Thomas Lehnhoff and Peter Laumen and Paul Lingor and Karla Lippmann and Michael Lorrain and Fabian Maass and Siegfried Muhlack and Thomas M{\"u}ller and Michael Nagel and Stephan Neudecker and Katja Odin and Christian Oehlwein and Hakan Orbasli and {Von Pannwitz}, Wolfram and Heidi Pape and Robert Pfister and Tino Prell and Reinhard Puzich and Daniela Rau and Rene Reese and Gerd Reifschneider and Gernot Reimann and Stefani Ries and Christoph Rieth and Charlotte Rewitzer and Ali Safavi and Schmied, {Alexander B.} and Johannes Schwarz and Wolfgang Schwarz and Joachim Springub and Claus, {Inga Suttrup} and Vera Tadic and Klaus Tiel-Wilck and Lars T{\"o}nges and Jens Tr{\"o}ger and Christoph Schrey and Alexander Schulze and Sven Thonke and Tobias W{\"a}chter and Wannenmacher, {Achim S.} and Tobias Warnecke and Bettina Wieder and Martin Wimmer and Christian Winkler and Otto Witte and Dirk Woitalla and Samis Zella and Uwe Ziebold and Jane Alty and Reem Amin and Michaela Boca and Stephen Butterworth and Camille Carroll and Gavin Charlesworth and Chaudhuri, {K. Ray} and Rajkumar Chinnadurai and Jemima Collins and Cosgrove, {Jeremy Stephen} and Samantha Cravey and Dinesh Damodaran and Nikolay Dimitrov and Rory Durcan and Simon Ellis and Adbdul Elmarimi and Jonathan Evans and James Fisher and Donald Grosset and Stuart Jamieson and Christopher Kobylecki and Lim, {Sze Hway} and Veronica Lyell and Biju Mohamed and Sophie Molloy and Nicola Pavese and Dominic Paviour and Madeleine Purchas and Khalid Rashed and Christopher Rickards and Tabish Saifee and Gillian Sare and Christine Schofield and Naveen Setty and Jagdish Sharma and Ray Sheridan and Shu, {Siew Lee} and Monty Silverdale and Rani Sophia and Sarah Statton and Malcolm Steiger and Christopher Thomas and Richard Walker and Foung, {Tai Yen}",

note = "Publisher Copyright: {\textcopyright} 2020 The Author(s).",

year = "2020",

month = mar,

day = "4",

doi = "10.1186/s40035-020-00187-1",

language = "English",

volume = "9",

journal = "Translational Neurodegeneration",

issn = "2047-9158",

publisher = "BioMed Central Ltd.",

number = "1",

}

Reichmann, H, Lees, A, Rocha, JF, Magalhães, D, Soares-Da-Silva, P, Zolnai, CA, Bartels, C, Barth, A, Barth, K, Behrens, S, Bergmann, A, Bodenschatz, R, Born, R, Brandt, M, Brock, S, Brockmeier, B, Brücke, C, Brüggemann, N, Bühler, B, Bungard, U, Cepek, L, Csoti, I, Deist, M, Reimers, CD, Dölle, U, Domke, S, Dzialowski, I, Ebersbach, G, Eggert, H, Eggert, K, Ehret, R, Engel, J, Fietzek, U, Friedrich, A, Fritzinger, M, Gandor, F, Gehring, K, Gierer, S, Gierer, S, Gjaurov, V, Gruber, D, Günes, Ö, Haas, T, Hahn, K, Haraszti, AE, Hartmann, R, Haslinger, B, Heiss, E, Herbst, HP, Hoffmann, F, Hofmann, WE, Höglinger, G, Jost, W, Kavcic, AM, Kellinghaus, C, Klemperer, B, Klostermann, F, Knoll, T, Koleva-Alazeh, N, Koschel, J, Kraft-Safavi, DW, Kronenberger, A, Kühn, A, Kupsch, A, Lehnhoff, T, Laumen, P, Lingor, P, Lippmann, K, Lorrain, M, Maass, F, Muhlack, S, Müller, T, Nagel, M, Neudecker, S, Odin, K, Oehlwein, C, Orbasli, H, Von Pannwitz, W, Pape, H, Pfister, R, Prell, T, Puzich, R, Rau, D, Reese, R, Reifschneider, G, Reimann, G, Ries, S, Rieth, C, Rewitzer, C, Safavi, A, Schmied, AB, Schwarz, J, Schwarz, W, Springub, J, Claus, IS, Tadic, V, Tiel-Wilck, K, Tönges, L, Tröger, J, Schrey, C, Schulze, A, Thonke, S, Wächter, T, Wannenmacher, AS, Warnecke, T, Wieder, B, Wimmer, M, Winkler, C, Witte, O, Woitalla, D, Zella, S, Ziebold, U, Alty, J, Amin, R, Boca, M, Butterworth, S, Carroll, C, Charlesworth, G, Chaudhuri, KR, Chinnadurai, R, Collins, J, Cosgrove, JS, Cravey, S, Damodaran, D, Dimitrov, N, Durcan, R, Ellis, S, Elmarimi, A, Evans, J, Fisher, J, Grosset, D, Jamieson, S, Kobylecki, C, Lim, SH, Lyell, V, Mohamed, B, Molloy, S, Pavese, N, Paviour, D, Purchas, M, Rashed, K, Rickards, C, Saifee, T, Sare, G, Schofield, C, Setty, N, Sharma, J, Sheridan, R, Shu, SL, Silverdale, M, Sophia, R, Statton, S, Steiger, M, Thomas, C, Walker, R & Foung, TY 2020, 'Effectiveness and safety of opicapone in Parkinson's disease patients with motor fluctuations: The OPTIPARK open-label study', Translational Neurodegeneration, Jg. 9, Nr. 1, 9. https://doi.org/10.1186/s40035-020-00187-1

TY - JOUR

T1 - Effectiveness and safety of opicapone in Parkinson's disease patients with motor fluctuations

T2 - The OPTIPARK open-label study

AU - Reichmann, Heinz

AU - Lees, Andrew

AU - Rocha, José Francisco

AU - Magalhães, Diogo

AU - Soares-Da-Silva, Patrício

AU - Zolnai, Csaba Antal

AU - Bartels, Claudius

AU - Barth, Andreas

AU - Barth, Kriemhild

AU - Behrens, Stephan

AU - Bergmann, Arnfin

AU - Bodenschatz, Ralf

AU - Born, Rommy

AU - Brandt, Moriz

AU - Brock, Sebastian

AU - Brockmeier, Bernd

AU - Brücke, Christof

AU - Brüggemann, Norbert

AU - Bühler, Bernhard

AU - Bungard, Uwe

AU - Cepek, Lukas

AU - Csoti, Ilona

AU - Deist, Max

AU - Reimers, Carl Detlev

AU - Dölle, Ulrich

AU - Domke, Sylke

AU - Dzialowski, Imanuel

AU - Ebersbach, Georg

AU - Eggert, Heike

AU - Eggert, Karla

AU - Ehret, Reinhard

AU - Engel, Jana

AU - Fietzek, Urban

AU - Friedrich, Anke

AU - Fritzinger, Michael

AU - Gandor, Florin

AU - Gehring, Klaus

AU - Gierer, Stephan

AU - Gierer, Stephanie

AU - Gjaurov, Vasil

AU - Gruber, Doreen

AU - Günes, Özkan

AU - Haas, Thomas

AU - Hahn, Kirsten

AU - Haraszti, Anna Eszter

AU - Hartmann, Rolf

AU - Haslinger, Bernhard

AU - Heiss, Eva

AU - Herbst, Heinz P.

AU - Hoffmann, Frank

AU - Hofmann, Werner E.

AU - Höglinger, Günter

AU - Jost, Wolfgang

AU - Kavcic, Anna Maria

AU - Kellinghaus, Christoph

AU - Klemperer, Bertold

AU - Klostermann, Fabian

AU - Knoll, Thomas

AU - Koleva-Alazeh, Natalia

AU - Koschel, Jiri

AU - Kraft-Safavi, Diana Waltraud

AU - Kronenberger, Almut

AU - Kühn, Andrea

AU - Kupsch, Andreas

AU - Lehnhoff, Thomas

AU - Laumen, Peter

AU - Lingor, Paul

AU - Lippmann, Karla

AU - Lorrain, Michael

AU - Maass, Fabian

AU - Muhlack, Siegfried

AU - Müller, Thomas

AU - Nagel, Michael

AU - Neudecker, Stephan

AU - Odin, Katja

AU - Oehlwein, Christian

AU - Orbasli, Hakan

AU - Von Pannwitz, Wolfram

AU - Pape, Heidi

AU - Pfister, Robert

AU - Prell, Tino

AU - Puzich, Reinhard

AU - Rau, Daniela

AU - Reese, Rene

AU - Reifschneider, Gerd

AU - Reimann, Gernot

AU - Ries, Stefani

AU - Rieth, Christoph

AU - Rewitzer, Charlotte

AU - Safavi, Ali

AU - Schmied, Alexander B.

AU - Schwarz, Johannes

AU - Schwarz, Wolfgang

AU - Springub, Joachim

AU - Claus, Inga Suttrup

AU - Tadic, Vera

AU - Tiel-Wilck, Klaus

AU - Tönges, Lars

AU - Tröger, Jens

AU - Schrey, Christoph

AU - Schulze, Alexander

AU - Thonke, Sven

AU - Wächter, Tobias

AU - Wannenmacher, Achim S.

AU - Warnecke, Tobias

AU - Wieder, Bettina

AU - Wimmer, Martin

AU - Winkler, Christian

AU - Witte, Otto

AU - Woitalla, Dirk

AU - Zella, Samis

AU - Ziebold, Uwe

AU - Alty, Jane

AU - Amin, Reem

AU - Boca, Michaela

AU - Butterworth, Stephen

AU - Carroll, Camille

AU - Charlesworth, Gavin

AU - Chaudhuri, K. Ray

AU - Chinnadurai, Rajkumar

AU - Collins, Jemima

AU - Cosgrove, Jeremy Stephen

AU - Cravey, Samantha

AU - Damodaran, Dinesh

AU - Dimitrov, Nikolay

AU - Durcan, Rory

AU - Ellis, Simon

AU - Elmarimi, Adbdul

AU - Evans, Jonathan

AU - Fisher, James

AU - Grosset, Donald

AU - Jamieson, Stuart

AU - Kobylecki, Christopher

AU - Lim, Sze Hway

AU - Lyell, Veronica

AU - Mohamed, Biju

AU - Molloy, Sophie

AU - Pavese, Nicola

AU - Paviour, Dominic

AU - Purchas, Madeleine

AU - Rashed, Khalid

AU - Rickards, Christopher

AU - Saifee, Tabish

AU - Sare, Gillian

AU - Schofield, Christine

AU - Setty, Naveen

AU - Sharma, Jagdish

AU - Sheridan, Ray

AU - Shu, Siew Lee

AU - Silverdale, Monty

AU - Sophia, Rani

AU - Statton, Sarah

AU - Steiger, Malcolm

AU - Thomas, Christopher

AU - Walker, Richard

AU - Foung, Tai Yen

PY - 2020/3/4

Y1 - 2020/3/4

N2 - 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).

AB - 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).

KW - Levodopa

KW - Motor fluctuations

KW - Open-label

KW - Opicapone

KW - Parkinson's disease

UR - http://www.scopus.com/inward/record.url?scp=85081229949&partnerID=8YFLogxK

U2 - 10.1186/s40035-020-00187-1

DO - 10.1186/s40035-020-00187-1

M3 - Article

AN - SCOPUS:85081229949

SN - 2047-9158

VL - 9

JO - Translational Neurodegeneration

JF - Translational Neurodegeneration

IS - 1

M1 - 9

ER -

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

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