Abstract
BackgroundThe efficacy and safety of opicapone, a once-daily catechol-O-methyltransferase inhibitor, have been established in two large randomized, placebo-controlled, multinational pivotal trials. Still, clinical evidence from routine practice is needed to complement the data from the pivotal trials.MethodsOPTIPARK (NCT02847442) was a prospective, open-label, single-arm trial conducted in Germany and the UK under clinical practice conditions. Patients with Parkinson’s disease and motor fluctuations were treated with opicapone 50 mg for 3 (Germany) or 6 (UK) months in addition to their current levodopa and other antiparkinsonian treatments. The primary endpoint was the Clinician’s Global Impression of Change (CGI-C) after 3 months. Secondary assessments included Patient Global Impressions of Change (PGI-C), the Unified Parkinson’s Disease Rating Scale (UPDRS), Parkinson’s Disease Questionnaire (PDQ-8), and the Non-Motor Symptoms Scale (NMSS). Safety assessments included evaluation of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).ResultsOf the 506 patients enrolled, 495 (97.8%) took at least one dose of opicapone. Of these, 393 (79.4%) patients completed 3 months of treatment. Overall, 71.3 and 76.9% of patients experienced any improvement on CGI-C and PGI-C after 3 months, respectively (full analysis set). At 6 months, for UK subgroup only (n = 95), 85.3% of patients were judged by investigators as improved since commencing treatment. UPDRS scores at 3 months showed statistically significant improvements in activities of daily living during OFF (mean ± SD change from baseline: − 3.0 ± 4.6, p < 0.0001) and motor scores during ON (− 4.6 ± 8.1, p < 0.0001). The mean ± SD improvements of − 3.4 ± 12.8 points for PDQ-8 and -6.8 ± 19.7 points for NMSS were statistically significant versus baseline (both p < 0.0001). Most of TEAEs (94.8% of events) were of mild or moderate intensity. TEAEs considered to be at least possibly related to opicapone were reported for 45.1% of patients, with dyskinesia (11.5%) and dry mouth (6.5%) being the most frequently reported. Serious TEAEs considered at least possibly related to opicapone were reported for 1.4% of patients.ConclusionsOpicapone 50 mg was effective and generally well-tolerated in PD patients with motor fluctuations treated in clinical practice.Trial registrationRegistered in July 2016 at clinicaltrials.gov (NCT02847442).
Highlights
The success of levodopa used together with other antiparkinsonian drug classes means that most patients living with Parkinson’s disease (PD) enjoy a good quality of life for many years [1, 2]
Current treatment guidelines consider adjunctive treatment with catechol-O-methyltransferase (COMT) inhibitors, dopamine agonists and monoamine oxidase type B (MAO-B) inhibitors, as efficacious to reduce OFF time in patients treated with levodopa/dopa decarboxylase inhibitor (DDCI) therapy [8,9,10]
Study population Men and women (≥30 years) with idiopathic PD [22] were eligible if they reported symptoms of motor fluctuations as identified by at least one symptom on the 9-Symptom Wearing-off Questionnaire (WOQ-9) [23]
Summary
The success of levodopa used together with other antiparkinsonian drug classes means that most patients living with Parkinson’s disease (PD) enjoy a good quality of life for many years [1, 2]. Current treatment guidelines consider adjunctive treatment with catechol-O-methyltransferase (COMT) inhibitors, dopamine agonists and monoamine oxidase type B (MAO-B) inhibitors, as efficacious to reduce OFF time in patients treated with levodopa/dopa decarboxylase inhibitor (DDCI) therapy [8,9,10]. COMT inhibitors have been an established first-line strategy to manage motor fluctuations for over 25 years [11,12,13,14], and are the only adjunct class to directly address the peak-trough variations in plasma levodopa levels that clinically manifest as wearing-off fluctuations [15]. Opicapone (50 mg once daily) significantly increased levodopa bioavailability compared with both placebo and entacapone (200 mg TID) by increasing substantially the trough plasma levels and each dose systemic exposure time (half-life) by at least 1 h [17]. Clinical evidence from routine practice is needed to complement the data from the pivotal trials
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
