OPC, a once-daily catechol-O-methyltransferase inhibitor, proved effective in treatment of motor fluctuations in PD patients in two large, previously published, randomized, placebo-controlled, multinational trials (BIPARK-I and II) [1,2]. However, real-world clinical practice data are needed to complement evidence from these trials.

OPTIPARK was a prospective, open-label, uncontrolled, single-group, multicenter trial conducted in Germany and the UK under clinical practice conditions. PD patients with motor fluctuations were treated with OPC 50-mg for 3 (Germany) or 6 (UK) months in addition to current antiparkinsonian treatment. Primary efficacy endpoint was Clinician’s Global Impression of Change (CGIC) after 3 months. Secondary efficacy endpoints included Patient’s GIC (PGIC). Safety assessments included evaluation of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).

495 patients received at least one dose of OPC 50-mg (Safety Set), and 393/495 patients (79.4%) completed 3 months of study treatment. Mean age was 67.7 years, 63.6% were male, and mean duration of PD was 8.5 years. Overall, 71.3% and 76.8% of patients experienced improvement (very much/much/minimally improved) on CGIC and PGIC after 3 months, respectively (Full Analysis Set, n=477). TEAEs considered at least possibly related to OPC were reported for 223/495 patients (45.1%); most frequently reported (≥5% patients) were dyskinesia (11.5%) and dry mouth (6.5%). Most TEAEs (94.8% of events) were of mild or moderate intensity. SAEs were reported for 34/495 patients (6.9%); SAEs occurring in >1 patient were urinary tract infection (0.6%), femoral neck fracture (0.4%), visual hallucination (0.4%) and hypertension (0.4%).

OPC 50-mg was effective and generally well tolerated in PD patients with motor fluctuations treated in clinical practice.

1. Ferreira et al., Lancet Neurol. 2016;15(2):154-165.

2. Lees et al., JAMA Neurol. 2017;74(2):197-206.