Category: Parkinson’s Disease: Clinical Trials
Objective: This study evaluated the effect of once-daily opicapone (OPC) 50 mg versus entacapone (ENT) on Early Morning Dystonia (EMD) in Parkinson’s disease patients with motor fluctuations (MF) using item 35 part IV of the Unified Parkinson’s Disease Rating Scale (UPDRS).
Background: The catechol-O-methyltransferase inhibitor OPC proved effective for end-of-dose MF in patients with PD in two pivotal Phase III trials (BIPARK-I and II). BIPARK-I evaluated the effect of OPC 50 mg versus placebo (having ENT as an active-control) in motor symptoms, including EMD (UPDRS IV.35).
Method: UPDRS IV.35 data from BIPARK-I for the OPC 50 mg and ENT arms at baseline and at the end of the double-blind period were analysed. The proportion of patients with and without EMD at baseline was evaluated and the odds ratio (OR) of amelioration (for those with EMD) and relative risk (RR) of deterioration (for those without EMD) were analysed using the Fisher’s exact test.
Results: Overall, 237 patients (OPC, n=115; ENT, n=122) were included. At baseline, ~24% of patients in the OPC group versus 31% in the ENT group presented with EMD. At the end of the double-blind period, 63% and 17% of patients reported an amelioration following OPC and ENT treatment, respectively, with a significant OR of 8.5 favouring OPC (95%CI 2.75−25.19, p=0.0002). Similarly, at baseline, ~77% of OPC-treated and 69% of ENT-treated patients did not experience EMD. At the end of the double-blind period, 91% of OPC-treated and 95% of ENT-treated patients remained EMD-free with a non-significant 0.9 RR of deterioration between treatment arms (95%CI 0.86−1.04, p=0.3706).
Conclusion: Once-daily OPC 50 mg was associated with a significant improvement in EMD, with patients on OPC presenting a probability of 8.5-fold to become EMD-free compared with those on entacapone.
Supported by Bial
To cite this abstract in AMA style:
F. Stocchi, J. Ferreira, W. Poewe, O. Rascol, A. Antonini, J-F. Rocha. Early Morning Dystonia in Parkinson’s Patients Receiving Opicapone versus Entacapone: a Post-Hoc Analysis of BIPARK-I [abstract]. Mov Disord. 2022; 37 (suppl 2). https://www.mdsabstracts.org/abstract/early-morning-dystonia-in-parkinsons-patients-receiving-opicapone-versus-entacapone-a-post-hoc-analysis-of-bipark-i/. Accessed December 9, 2024.« Back to 2022 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/early-morning-dystonia-in-parkinsons-patients-receiving-opicapone-versus-entacapone-a-post-hoc-analysis-of-bipark-i/