Category: Parkinson’s Disease: Clinical Trials
Objective: This study was designed to assess the effect of opicapone (OPC) 50 mg once daily (QD) on levodopa (L-DOPA) pharmacokinetics (PK) in different L-DOPA/carbidopa (LD/CD) treatment-optimized regimens in patients with Parkinson’s disease (PD) who demonstrate end-of-dose motor fluctuations.
Background: OPC is a QD catechol-O-methyltransferase inhibitor with proven efficacy in the treatment of end-of-dose motor fluctuations in patients with PD [1,2]. L-DOPA is considered the gold standard treatment of PD, yet comes with side effects including motor fluctuations and dyskinesia. Therefore, many physicians follow a dopa-optimization strategy.
Method: Twenty-four medically stable PD patients with a total daily LD/CD dose of 500/125 mg [preferred administration of 5 doses per day (Q5)]. From enrolment (V2) up to 14±2 days, an LD/CD-reference treatment of 100/25 mg LD/CD Q5 (500/125 mg total daily dose) will be applied. At baseline (V3), patients will be equally randomized to:
– Q4 LD/CD-regimen of 400/100 mg total daily dose plus OPC 50 mg
– Q5 LD/CD-regimen of 400/100 mg total daily dose plus OPC 50 mg
Patients will maintain the LD/CD regimen for up to 14±2 days (V4). PK assessments for LD/CD-reference will be performed at V3 and for both LD/CD+OPC regimens at V4 (Figure 1).
Results: The primary endpoint will be PK based. Secondary endpoints include tolerability, functional motor assessments (subject diary charts for ON/OFF periods), and Patient Global Impression of Change scale (PGI-C). First-patient-in and last-patient-out are expected in 2021. Timelines might be impacted by the COVID-19 pandemic situation.
Conclusion: This study will evaluate effect of OPC on L-DOPA PK in different LD/CD treatment-optimized regimens in patients with PD and end-of-dose motor fluctuations.
References: 1. Ferreira et al., Lancet Neurol. 2016;15(2):154-165 2. Lees et al., JAMA Neurol. 2017;74(2):197-206
To cite this abstract in AMA style:
J. Ferreira, W. Poewe, O. Rascol, F. Stocchi, A. Antonini, J. Moreira, J. Rocha, P. Soares-da-Silva. Study Design to Assess the Effect of Opicapone on Levodopa PK at Different Levodopa-Optimized Treatment Regimens in Parkinson’s Disease Patients [abstract]. Mov Disord. 2021; 36 (suppl 1). https://www.mdsabstracts.org/abstract/study-design-to-assess-the-effect-of-opicapone-on-levodopa-pk-at-different-levodopa-optimized-treatment-regimens-in-parkinsons-disease-patients/. Accessed May 16, 2025.« Back to MDS Virtual Congress 2021
MDS Abstracts - https://www.mdsabstracts.org/abstract/study-design-to-assess-the-effect-of-opicapone-on-levodopa-pk-at-different-levodopa-optimized-treatment-regimens-in-parkinsons-disease-patients/