ORIGINAL RESEARCH article
Front. Neurol.
Sec. Movement Disorders
Real-world data of opicapone in patients with Parkinson's disease experiencing motor fluctuations: The OPTIMO study
Rosario Luquin Piudo 1
Nuria López Ariztegui 2
Juan Carlos Martinez Castrillo 3
Lydia López Manzanares 4
Isabel Sastre Bataller 5
Antonio Koukoulis Fernández 6
Bárbara Vives Pastor 7
Berta Solano Vila 8
Maria Alvarez Sauco 9
Javier Pagonabarraga Mora 10
José Matias Arbelo González 11
Pedro J Garcia Ruiz-Espiga 12
Oriol de Fàbregues 13
Javier López del Val 14
Víctor Campos Arillo 15
Clara Moreno 16
José Blanco Ameijeiras 16
Isabel Pijuan Jiménez 16
Iciar Tegel Ayuela 16
1. Neurology, University of Navarra, Pamplona, Spain, Navarra, 31008
2. Movement Disorders Unit, Hospital General Universitario de Toledo, Toledo, Spain
3. Neurology, IRYCIS, Hospital Universitario Ramon y Cajal, Madrid, Spain
4. Hospital Universitario de la Princesa, Madrid, Spain
5. Hospital Universitari i Politecnic La Fe, Valencia, Spain
6. Hospital Alvaro Cunqueiro, Vigo, Spain
7. Hospital Universitario Son Espases, Palma, Spain
8. Hospital Universitari de Girona Doctor Josep Trueta, Girona, Spain
9. Hospital General Universitario de Elche, Elche, Spain
10. Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
11. Hospital Universitario San Roque, Las Palmas de Gran Canaria, Spain
12. Hospital Universitario Fundacion Jimenez Diaz, Madrid, Spain
13. Hospital Universitari Vall d'Hebron, Barcelona, Spain
14. Clínica HLA Montpellier, Zaragoza, Spain
15. Hospital Vithas Xanit Internacional, Benalmádena, Spain
16. Medical Department, Laboratorios Bial S.A., Madrid, Spain
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Abstract
Purpose: Evaluate the outcomes of opicapone as an add-on treatment to levodopa/DDCI in patients with Parkinson's disease (PD) and motor fluctuations (MF) in a real-world setting. Methods: Observational, retrospective, and post-authorization study in patients with PD and MF treated with opicapone at 16 Spanish Movement Disorders centers. Results: Of 245 patients included (55.9% men; mean [standard deviation] age: 67.7 [10.4] years), 41.9% and 33.6% presented rigid-akinetic and tremor-dominant phenotypes, respectively; 43.8% had a history of dyskinesias. Patients started treatment with 50 mg/day opicapone 8.3 (5.3) years after diagnosis. At initiation, the mean levodopa dose was 620.7 (313.7) mg/day. According to the PGI-C (available in 178 patients), 74.2% of patients reported clinical improvement in MF, without worsening of dykinesias in 64.6%. Clinical improvement of MF with stable/improved dyskinesias was similar between PD phenotypes (p=0.327). Opicapone reduced the percentage of patients experiencing wearing-off phenomena (98.0% vs. 61.6%), delayed-on (10.2% vs. 5.3%; p=0.010), noon (6.5% vs. 2.9%; p=0.027), and non-motor fluctuations (21.6% vs. 15.1%; p=0.010). Furthermore, the off-time decreased (143.3 vs. 67.9 minutes/day; p<0.001). After 4.8 (3.6) months of treatment, scores in UPDRS Parts II-IV significantly decreased, suggesting additional improvements in daily activities and motor function. The mean daily time with dyskinesias did not increase after initiating opicapone. Mild adverse events were observed in 21 (8.3%) patients. Conclusions: This study demonstrates that opicapone added to levodopa improves motor function and reduces MF without significantly enhancing dyskinesia intensity, along with a tolerable profile. Moreover, there were no differences regarding clinical improvement among PD phenotypes.
Summary
Keywords
catechol-o-methyltransferase inhibitors, Motor fluctuations, Opicapone, Parkinson's disease, Real-world data, Wearing-off
Received
03 November 2025
Accepted
22 January 2026
Copyright
© 2026 Luquin Piudo, López Ariztegui, Martinez Castrillo, López Manzanares, Sastre Bataller, Koukoulis Fernández, Vives Pastor, Solano Vila, Alvarez Sauco, Pagonabarraga Mora, Arbelo González, Garcia Ruiz-Espiga, de Fàbregues, López del Val, Campos Arillo, Moreno, Blanco Ameijeiras, Pijuan Jiménez and Tegel Ayuela. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
*Correspondence: Rosario Luquin Piudo
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