Opicapone as adjunct to levodopa in treated Parkinson's disease without motor complications: A randomized clinical trial
| Title: | Opicapone as adjunct to levodopa in treated Parkinson's disease without motor complications: A randomized clinical trial |
|---|---|
| Authors: | Ferreira, Joaquim J.; Rascol, Olivier; Stocchi, Fabrizio; Antonini, Angelo; Moreira, Joana; Castilla‐Fernández, Guillermo; Rocha, José‐Francisco; Holenz, Joerg; Poewe, Werner; Emke Marechal; Bruno Bergmans; Mieke De Weweire; Teodora Manolova-Mancheva; Aleksandar Bosilkov; Lyubomir Haralanov; Ivan Milanov; Rosen Ikonomov; Krasimir Kirilov; Valcho Naydenov; Alim Izmailov; Latchezar Traykov; Marek Balaz; Ladislav Pazdera; Michal Bajacek; Ondrej Skoda; Luisa Bartlova; Radomir Talab; Jakub Hort; Martin Valis; Edvard Ehler; Olivier Rascol; Sophie Drapier; Luc Defebvre; Stephane Thobois; Giovanni Castelnovo; Lars Toenges; Patricia Krause; Bjorn Falkenburger; Johannes Schwarz; Fabian Klostermann; Alfons Schnitzler; Maria Antonietta Volonte; Alessandro Tessitore; Paolo Barone; Carlo Colosimo; Giovanna Calandra Buonaura; Diego Centonze; Maria Francesca De Pandis; Laura Vacca; Angelo Antonini; Ewa Trzebinska-Frydrychowska; Joanna Siuda; Jerzy Machowski; Jan Ilkowski; Marcin Nastaj; Monika Rudzinska-Bar; Katarzyna Kasprzyk-Galon; Mariusz Grudniak; Joaquim J Ferreira; Miguel F Gago; Alexandre Mendes; Svetlana Kostic Dedic; Marina Svetel; Zorica Knezevic; Jasmina Jovic; Pablo Mir Rivera; Gurutz Linazasoro Cristobal; Ernest Balaguer Martinez; Tania Delgado Ballestero; Francesc Valldeoriola Serra; Jerzy Krupinski; Nuria Caballol Pons; Matilde Calopa Garriga; Eduardo Aguera Morales; Jorge Hernandez Vara; Raif Cakmur; Hasmet Hanagasi; Ferda Uslu; Okan Dogu; Bulent Elibol; Camille Carroll; Richard Walker; David Ledingham; Esther Sammler; Victoria Marshall; Ihor Pasiura; Nataliia Buchakchyiska; Liudmyla Dziak; Sergii Moskovko; Yanosh Sanotskyy; Olexandr Kozyolkin; Tatyana Slobodin |
| Contributors: | Joaquim J., F; Olivier, R; Fabrizio, S; Angelo, A; Joana, M; Guillermo, C; José‐francisco, R; Joerg, H; Werner, P; Marechal, E; Bergmans, B; De Weweire, M; Manolova-Mancheva, T; Bosilkov, A; Haralanov, L; Milanov, I; Ikonomov, R; Kirilov, K; Naydenov, V; Izmailov, A; Traykov, L; Balaz, M; Pazdera, L; Bajacek, M; Skoda, O; Bartlova, L; Talab, R; Hort, J; Valis, M; Ehler, E; Rascol, O; Drapier, S; Defebvre, L; Thobois, S; Castelnovo, G; Toenges, L; Krause, P; Falkenburger, B; Schwarz, J; Klostermann, F; Schnitzler, A; Antonietta Volonte, M; Tessitore, A; Barone, P; Colosimo, C; Calandra Buonaura, G; Centonze, D; Francesca De Pandis, M; Vacca, L; Antonini, A; Trzebinska-Frydrychowska, E; Siuda, J; Machowski, J; Ilkowski, J; Nastaj, M; Rudzinska-Bar, M; Kasprzyk-Galon, K; Grudniak, M; J Ferreira, J; F Gago, M; Mendes, A; Kostic Dedic, S; Svetel, M; Knezevic, Z; Jovic, J; Mir Rivera, P; Linazasoro Cristobal, G; Balaguer Martinez, E; Delgado Ballestero, T; Valldeoriola Serra, F; Krupinski, J; Caballol Pons, N; Calopa Garriga, M; Aguera Morales, E; Hernandez Vara, J; Cakmur, R; Hanagasi, H; Uslu, F; Dogu, O; Elibol, B; Carroll, C; Walker, R; Ledingham, D; Sammler, E; Marshall, V; Pasiura, I; Buchakchyiska, N; Dziak, L; Moskovko, S; Sanotskyy, Y; Kozyolkin, O; Slobodin, T |
| Publisher Information: | WILEY |
| Publication Year: | 2025 |
| Collection: | Universitá degli Studi di Roma "Tor Vergata": ART - Archivio Istituzionale della Ricerca |
| Subject Terms: | COMT; Parkinson's disease; clinical trial; levodopa; opicapone; Settore MED/26; Settore MEDS-12/A - Neurologia |
| Description: | BACKGROUND: Catechol-O-methyl transferase (COMT) inhibitors are routinely used to manage motor fluctuations in Parkinson's disease (PD). We assessed the effect of opicapone on motor symptom severity in levodopa-treated patients without motor complications. METHODS: This was a randomized, double-blind, 24-week, placebo-controlled study of opicapone 50 mg as adjunct to levodopa (NCT04978597). Levodopa-treated patients without motor complications were randomized to 24 weeks of double-blind treatment with adjunct opicapone 50 mg or matching placebo. The primary efficacy endpoint was the mean change from baseline to week 24 in Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) total score. RESULTS: A total of 355 patients were randomized (opicapone 50 mg n = 177, placebo n = 178) and 322 (91%) completed the double-blind period. The adjusted mean [95% CI] change from baseline to week 24 in MDS-UPDRS-III subscore was -6.5 [-7.9, -5.2] in the opicapone group versus -4.3 [-5.7, 3.0] in the placebo group resulting in a significant difference of -2.2 [-3.9, -0.5] favoring opicapone (p = 0.010). There was no difference in the incidence of patients who developed motor complications (5.5% with opicapone vs. 9.8% with placebo) and the incidence of adverse events considered related to study medication was similar between groups (opicapone 10.2% vs. placebo 13.5%). CONCLUSIONS: Treatment with once-daily adjunct opicapone was well tolerated, improved motor severity, and did not induce the development of motor complications. These results support the clinical usefulness of opicapone in the management of PD patients without motor complications. |
| Document Type: | article in journal/newspaper |
| Language: | English |
| Relation: | info:eu-repo/semantics/altIdentifier/pmid/39790009; info:eu-repo/semantics/altIdentifier/wos/WOS:001394745200001; volume:32; issue:1; firstpage:1; lastpage:10; numberofpages:10; journal:EUROPEAN JOURNAL OF NEUROLOGY; https://hdl.handle.net/2108/402068 |
| DOI: | 10.1111/ene.16420 |
| Availability: | https://hdl.handle.net/2108/402068; https://doi.org/10.1111/ene.16420 |
| Rights: | info:eu-repo/semantics/openAccess ; license:Creative commons ; license uri:http://creativecommons.org/licenses/by/4.0/ |
| Accession Number: | edsbas.9026E49D |
| Database: | BASE |