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Abstract Details

Long-term Efficacy of Opicapone in the Reduction of ON-time with Troublesome Dyskinesia in Parkinson’s Disease Patients with Motor Fluctuations and Reporting Troublesome Dyskinesia
Movement Disorders
Movement Disorders Posters (7:00 AM-5:00 PM)
127

To evaluate ON-time with troublesome dyskinesia (frequently called ´Bad ON-time’) and ON-time with no dyskinesia or with non-troublesome dyskinesia (‘Good ON-time’) following long-term opicapone exposure in Parkinson’s disease (PD) patients with motor fluctuations.

Opicapone is a once-daily catechol-O-methyltransferase inhibitor approved as adjunctive treatment to levodopa/carbidopa in PD patients experiencing OFF episodes. 
Matching efficacy data from BIPARK-I and II were combined for opicapone 50mg. The studies had similar designs, eligibility criteria, and methodologies. Primary efficacy endpoint was change from baseline in OFF-time based on patient diaries. This post-hoc analysis evaluated the long-term effect of opicapone 50mg on ‘Bad ON-time’ only in patients with troublesome dyskinesia at baseline and on ‘Good ON-time’ only in patients with no/non-troublesome dyskinesia at baseline. 
Of 216 patients in the Full Analysis Set, 44 (20.4%) reported ~2 hours of ‘Bad ON-time’ and ~9 hours of ‘Good ON-time’ at baseline. Following initiation with opicapone 50mg to the end of the double-blind period (~3.5 months), an increase of ~1.4 hours in ‘Good ON-time’ and a decrease of ~5 minutes in ‘Bad ON-time’ were observed, with an overall mean levodopa reduction of ~40mg/day. At the end of the 1-year open-label extension (OLE) period, mean daily ‘Good ON-time’ increased by ~2 hours (from 8.9 hours at double-blind baseline to 10.9 hours OLE), mean daily ‘Bad ON-time’ decreased by ~1 hour (from 2.0 hours at double-blind baseline to 1.1 hours OLE), and mean daily levodopa dose decreased by an additional 60mg for a total decrease of 100mg (from 740mg at double-blind baseline to 640mg at end of OLE).

In PD patients with motor fluctuations and reporting troublesome dyskinesia, exposure to opicapone for almost 1 year was associated with reduced levodopa dose, reduced ON-time with troublesome dyskinesia, and increased ON-time with no/non-troublesome dyskinesia.

Authors/Disclosures
Olga Klepitskaya, MD, FÂé¶¹´«Ã½Ó³»­ (Neurocrine Biosciences, Inc)
PRESENTER
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
Joaquim J. Ferreira The institution of Joaquim J. Ferreira has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Bial, Neurocrine, AbbVie, Biogen and Lundbeck. The institution of Joaquim J. Ferreira has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neurocrine, AbbVie, BIAL, Biogen, Lundbeck . The institution of Joaquim J. Ferreira has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for AbbVie, BIAL, Nordic Infucare, ONO and SK Chemicals.
Diogo Magalhães Diogo Magalhães has received personal compensation for serving as an employee of BIAL.
Francisco Rocha Francisco Rocha has received personal compensation for serving as an employee of BIAL - Portela.
Patricio Soares-da-Silva Patricio Soares-da-Silva has received personal compensation for serving as an employee of Bial - Portela & Cª S.A.. Patricio Soares-da-Silva has received personal compensation in the range of $100,000-$499,999 for serving as an officer or member of the Board of Directors for Bial - Portela & Cª S.A..