Category: Parkinson’s Disease: Clinical Trials
Objective: To describe motor complications as measured by the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part IV in participants from the Opicapone Treatment Initiation Open-Label Study (OPTI-ON).
Background: Opicapone is an oral, once-daily, selective catechol-O-methyltransferase inhibitor approved as an adjunctive treatment to levodopa/carbidopa (LD/CD) in patients with Parkinson’s disease (PD) experiencing “OFF” episodes. OPTI-ON was designed to evaluate the use of opicapone in real-world treatment settings in the United States, focusing on patient characteristics, treatment patterns, and clinical outcomes.
Method: OPTI-ON was a prospective, open-label, observational, longitudinal (6-month) study of patients with PD experiencing “OFF” episodes who received opicapone in addition to their LD/CD regimens. MDS-UPDRS Part IV (motor complications) was assessed at baseline and throughout follow-up. It was scored as the sum of six item scores, each of which ranged from 0 (normal) to 4 (severe). Data were analyzed descriptively, with mean change from baseline (CFB) presented with standard deviation (SD).
Results: Of the 239 patients enrolled, 161 completed the study. Mean CFB (±SD) on the MDS-UPDRS Part IV was -1.7 (±3.3) at 3 months and -1.1 (±3.2) at 6 months. The largest improvements were observed in the three items pertaining to motor fluctuations: “time spent in the ‘OFF’ state,” “functional impact of fluctuations,” and “complexity of motor fluctuations” (mean CFBs for summed items: ‑1.8 at 3 months and -1.3 at 6 months).
Conclusion: In the OPTI-ON study, patients who received 6 months of adjunctive opicapone treatment had improvements in motor fluctuations (MDS-UPDRS Part IV). Along with the decreased duration of “OFF” episodes observed in Phase 3 clinical trials, these data suggest that adjunctive once-daily opicapone can improve the complexity of motor fluctuations in patients with PD.
To cite this abstract in AMA style:
C. Kilbane, R. Drake, O. Klepitskaya, M. Serbin, E. Jen, S. Rattana, J. Trotter, G. Liang. Improvements in Parkinson’s disease motor complications after treatment with opicapone: results from the OPTI-ON study [abstract]. Mov Disord. 2023; 38 (suppl 1). https://www.mdsabstracts.org/abstract/improvements-in-parkinsons-disease-motor-complications-after-treatment-with-opicapone-results-from-the-opti-on-study/. Accessed November 23, 2024.« Back to 2023 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/improvements-in-parkinsons-disease-motor-complications-after-treatment-with-opicapone-results-from-the-opti-on-study/