Title

OPTI-on: A longitudinal real-world study of opicapone in patients with parkinson's disease and motor fluctuations

Document Type

Conference Proceeding

Publication Date

10-1-2021

Publication Title

Annals of Neurology

Abstract

Background: Motor fluctuations and wearing-off of medications are common complications as Parkinson's disease (PD) progresses. Opicapone is an oral once-daily catechol-Omethyltransferase (COMT) inhibitor for adjunctive treatment to carbidopa/levodopa (CD/LD) in patients with PD and OFF-episodes. The efficacy and safety of opicapone was demonstrated in two phase 3 studies that were conducted in Europe and Asia (BIPARK-1 BIPARK-2). An observational phase 4 study in the United States (US), OPTI-ON (Opicapone Treatment Initiation Open-Label Study [NCT04787965]), is currently underway. This study examines treatment patterns, clinical outcomes, safety and tolerability of opicapone as an adjunctive treatment to CD/LD in patients with PD who are experiencing OFF-episodes.

Methods: OPTI-ON is an ongoing, prospective, multicenter open-label study of opicapone as an adjunctive treatment to CD/LD. Approximately 250 clinically eligible patients with PD and OFF-episodes are being enrolled at about 50 sites in the US. Participation in the study is expected to continue for up to 6 months. Assessments include patient demographics and clinical history, opicapone treatment decisions (reasons for initiation or discontinuation), use of other PD medications, and changes in PD medications. Clinician- and patient-rated outcomes (PROs) include: Clinician Global Impression of Change; MDS-Unified Parkinson's Disease Rating Scale, Parts 1A and 4 (clinician) Parts 1B and 2 (patient); Patient Global Impression of Change; Patient Global Impression of Severity in ON- and OFF-states; and 8-item Parkinson's Disease Questionnaire. This is also the first longitudinal study to implement the new clinician- and patient-rated Non-Motor Fluctuation Assessment. Assessments are completed online by patients (electronic PROs) and performed by clinicians during office visits or via telemedicine.

Results: Up-to-date findings will be presented.

Conclusions: Results from the OPTI-ON study are expected to provide real-world information about the patterns of use and outcomes with adjunctive opicapone for treatment of PD in clinical practices throughout the US. These results will expand upon findings from the phase 3 clinical trials which established the efficacy and safety of once-daily opicapone in patients with PD and OFF-episodes.

Volume

90

Issue

Suppl 27

First Page

S148

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