| Title: |
Effectiveness and safety of opicapone in Parkinson's disease patients with motor fluctuations: The OPTIPARK open-label study |
| Authors: |
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; 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 |
| Source: |
Translational Neurodegeneration , 9 (1) , Article 9. (2020) |
| Publication Year: |
2020 |
| Collection: |
University College London: UCL Discovery |
| Subject Terms: |
Levodopa; Motor fluctuations; Open-label; Opicapone; Parkinson’s disease |
| Description: |
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 ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
text |
| Language: |
English |
| Relation: |
https://discovery.ucl.ac.uk/id/eprint/10094215/1/Effectiveness%20and%20safety%20of%20opicapone%20in%20Parkinson%27s%20disease%20patients%20with%20motor%20fluctuations.pdf; https://discovery.ucl.ac.uk/id/eprint/10094215/ |
| Availability: |
https://discovery.ucl.ac.uk/id/eprint/10094215/1/Effectiveness%20and%20safety%20of%20opicapone%20in%20Parkinson%27s%20disease%20patients%20with%20motor%20fluctuations.pdf; https://discovery.ucl.ac.uk/id/eprint/10094215/7/s40035-020-00193-3.pdf; https://discovery.ucl.ac.uk/id/eprint/10094215/ |
| Rights: |
open |
| Accession Number: |
edsbas.B65A532D |
| Database: |
BASE |