Abstract Details

Title Patients Reported Improvement in Quality of “OFF” time, Severity of Non-Motor Fluctuations, and Medication Satisfaction in the OPTI-ON Study

Topic Movement Disorders

Presentation(s) S32 - Movement Disorders: Trials (4:42 PM-4:54 PM)

Poster/Presentation
Number 007

Objective To describe patient-reported outcomes (PROs) from the Opicapone Treatment Initiation Open-Label Study (OPTI-ON).

Background Opicapone is an oral, once-daily, selective catechol-O-methyltransferase (COMT) inhibitor used as adjunctive treatment to carbidopa/levodopa (CD/LD) in patients with Parkinson’s disease (PD) experiencing “OFF” episodes. The aim of the OPTI-ON study was to evaluate “real-world” patient characteristics, treatment patterns, and safety/tolerability of opicapone use in the US.

Design/Methods OPTI-ON was a prospective, open-label, single-arm, multicenter, observational, longitudinal (6-month) study of patients with PD experiencing “OFF” episodes who were prescribed opicapone adjunctive to CD/LD. PROs including the Patient Global Impression of Severity in the “OFF” state (PGI-S OFF), Patient Global Impression of Change (PGI-C), Non-Motor Fluctuations PGI-S (NMFs PGI-S), and Medication Satisfaction Questionnaire (MSQ) were obtained at baseline (BL) and throughout follow-up.

Results Overall, 164 patients completed the study. On the PGI-S OFF, more patients rated their “OFF” time symptom severity as none or very mild at 3 months (21.2%) and 6 months (20.4%) compared to BL (10.3%). For the PGI-C, 29.8% and 23.5% of patients were much or very much improved at months 3 and 6, respectively. On the NMFs PGI-S, fewer patients scored markedly to most extremely affected with NMFs at 6 months (3.2%) compared to BL (11.9%). On the MSQ, 42.3% of patients were very or extremely satisfied with their opicapone treatment at 6 months versus 14.2% with their treatment regimen at BL.

Conclusions After 6 months of opicapone treatment, patients reported improvement on the PGI-S OFF and PGI-C, reduced NMF severity on the NMFs PGI-S, and increased satisfaction on the MSQ. In addition to decreasing the duration of “OFF” episodes as shown in Phase 3 clinical studies, these results suggest once-daily opicapone may improve the quality of “OFF” time, more effectively manage motor fluctuations and NMFs in PD, and increase patients’ satisfaction with their PD treatment regimen.

Authors/Disclosures
Peter A. LeWitt, MD (Henry Ford Hospital - Franklin Pointe) PRESENTER	Dr. LeWitt has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. LeWitt has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for ONO Pharmaceuticals. Dr. LeWitt has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Supernus. The institution of Dr. LeWitt has received research support from Michael J Fox Foundation.
Olga Klepitskaya, MD, FAAN (Neurocrine Biosciences, Inc)	Dr. Klepitskaya has received personal compensation for serving as an employee of Neurocrine Biosciences, Inc. Dr. Klepitskaya has or had stock in Neurocrine Biosciences.
	No disclosure on file
Eric Jen (Neurocrine Biosciences, Inc.)	Eric Jen has received personal compensation for serving as an employee of Neurocrine Biosciences, Inc.
	No disclosure on file
	No disclosure on file
Grace L. Liang, MD	Dr. Liang has received personal compensation for serving as an employee of Neurocrine Biosciences. Dr. Liang has stock in Neurocrine Biosciences.

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