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 |
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| Authors: | Ferreira JJ; Rascol O; Stocchi F; Antonini A; Moreira J; Castilla-Fernandez G; Rocha J-F; Holenz J; Poewe W; 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; Drapier S; Defebvre L; Thobois S; Castelnovo G; Toenges L; Krause P; Falkenburger B; Schwarz J; Klostermann F; Schnitzler A; Volonte MA; Tessitore A; Barone P; Colosimo C; Buonaura GC; Centonze D; De Pandis MF; Vacca L; Trzebinska-Frydrychowska E; Siuda J; Machowski J; Ilkowski J; Nastaj M; Rudzinska-Bar M; Kasprzyk-Galon K; Grudniak M; Gago MF; Mendes A; Dedic SK; Svetel M; Knezevic Z; Jovic J; Rivera PM; Cristobal GL; Martinez EB; Ballestero TD; Serra FV; Krupinski J; Pons NC; Garriga MC; Morales EA; Vara JH; 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 |
| Source: | European Journal of Neurology, January 2025 |
| Publisher Information: | John Wiley and Sons Inc |
| Publication Year: | 2025 |
| Collection: | Newcastle University Library ePrints Service |
| Description: | © 2024 The Author(s). European Journal of Neurology published by John Wiley & Sons Ltd on behalf of European Academy of Neurology.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 |
| File Description: | application/pdf |
| Language: | unknown |
| Relation: | https://eprints.ncl.ac.uk/304249; https://eprints.ncl.ac.uk/fulltext.aspx?url=304249/1F341515-D5E6-458A-B1E1-4E95F58F0FD2.pdf&pub_id=304249 |
| Availability: | https://eprints.ncl.ac.uk/304249 |
| Rights: | https://creativecommons.org/licenses/by/4.0/ |
| Accession Number: | edsbas.3700359 |
| Database: | BASE |