Category: Parkinson’s Disease: Clinical Trials
Objective: To describe the real-world use of catechol-O-methyltransferase (COMT) inhibitors add on to levodopa/dopa decarboxylase inhibitor (DDCI) in patients with Parkinson’s disease (PD) suffering from early motor fluctuations.
Background: Levodopa (L-dopa) is the gold standard in the symptomatic treatment of PD. After 2 years, up to 50% of patients with PD may experience motor fluctuations [1]. The administration of a COMT inhibitor extends the bioavailability of L-dopa and may lead to a more continuous delivery of L-dopa to the brain [2]. Available COMT inhibitors include opicapone, entacapone and tolcapone. Existing evidence shows comparable efficacy of COMT inhibitors in reducing off-time and increase on-time in both patients with recent motor fluctuations and those with long-standing motor fluctuations, but with less incidence of dyskinesias in recent versus long-standing motor fluctuators (11.8% vs. 23.5%) [3]. Thus, this study aims to evaluate the effectiveness of COMT inhibitors in relieving motor complications associated with L-dopa treatment in PD patients with early motor fluctuations.
Method: Approximately 300 patients with idiopathic PD treated with L-dopa/DDCI and showing signs of wearing-off with an onset ≤2 years of the registry entry (early motor fluctuations), will be included and followed up to 2 years after initiating treatment with a COMT inhibitor.
Results: The primary endpoint includes the following measures: COMT inhibitor used, daily dose and frequency of dosing; L-dopa daily dosage and changes in L-dopa usage. The secondary endpoints include: adverse events; functional motor and non-motor assessments (MDS-Unified Parkinson’s Disease Rating Scale [UPDRS]; Parkinson’s Disease Questionnaire-8 [PDQ-8]; Non-Motor Symptoms Scale [NMSS]; Wearing-off Questionnaire-19 [WOQ-19]; and global impression of change scales). First patient was included in January 2022 and last-patient-out is expect for 2026, with interim analysis foreseen.
Conclusion: This registry will help to leverage the use of COMT inhibitors in patients with PD who present early motor fluctuations in routine clinical practice in Spain.
References: 1. Mov Disord. 2013;28:1064-71. 2. Eur Neurol. 2010;63(5):257-66. 3. Mov Disord. 2020;35(suppl 1):444
To cite this abstract in AMA style:
L. Lopez-Manzanares, E. Casas-Peña, I. Muro-Garcia, I. Caballero, F. Almeida, I. Tegel, P. Sarasa. The REONPARK (REgistry of the use of COMT-inhibitors in the maNagement of patients with PARKinson’s disease in Spain who present early motor fluctuations) study: rationale and design of a national, multicentre and prospective study [abstract]. Mov Disord. 2022; 37 (suppl 2). https://www.mdsabstracts.org/abstract/the-reonpark-registry-of-the-use-of-comt-inhibitors-in-the-management-of-patients-with-parkinsons-disease-in-spain-who-present-early-motor-fluctuations-study-rationale-and-design-of-a-nati/. Accessed June 15, 2025.« Back to 2022 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/the-reonpark-registry-of-the-use-of-comt-inhibitors-in-the-management-of-patients-with-parkinsons-disease-in-spain-who-present-early-motor-fluctuations-study-rationale-and-design-of-a-nati/