Abstract Details

Title Effect of Opicapone on Sleep-related Complaints and Non-motor Burden in Parkinson’s Patients: A Post-hoc Analysis of the OASIS Trial

Topic Movement Disorders

Presentation(s) P3 - Poster Session 3 (5:00 PM-6:00 PM)

Poster/Presentation
Number 17-012

Objective To assess the effect of opicapone (OPC) on different sleep complaints and non-motor symptoms (NMS) in Parkinson’s disease (PD) patients with sleep disturbances.

Background Sleep disturbances and NMS are common and challenging to manage in PD patients. By optimizing levodopa, OPC may alleviate specific PD-related sleep issues and NMS burden in PD patients with motor fluctuations.

Design/Methods The 6-week, open-label, OASIS trial evaluated the efficacy of OPC 50mg in treating sleep disturbances as levodopa add-on therapy. Primary endpoint was change from baseline to Week 6 in PD Sleep Scale-2 (PDSS-2) total score. This post-hoc analysis evaluated changes in specific PDSS-2 items and Movement Disorder Society-sponsored NMS rating scale (MDS-NMS) domains at Week 6.

Results Of the 16 patients included, 15 completed the treatment. At Week 6, patients experienced improvements in several sleep issues, as indicated by the mean (standard error [SE]) reductions in the scores for poor sleep quality in the previous week (-1.1 [0.3]; -42%), sleep latency (-0.9 [0.4]; -50%), sleep fragmentation (-1.3 [0.4]; -39%), and non-restorative sleep (-1 [0.3]; -41%). Patients also reported significantly less difficulty moving or turning in bed (-0.9 [0.3]; -35%) and less tremor upon waking (-0.7 [0.3]; -39%). The mean (SE) MDS-NMS score significantly decreased by -28.9 (7.3; p=0.0015), with a -6.4 (2.6; -31%; p=0.025) point reduction in the sleep/wakefulness domain, reflecting improvements in insomnia (-2.8 [1.1]; -43%; p=0.03) and unintentional daytime sleep episodes (-2.2 [0.8]; -41%, p=0.02). Reductions were seen across other MDS-NMS domains, including depression (-27%), anxiety (-35%), apathy (-31%), gastrointestinal (-27%), and pain (-26%).

Conclusions OPC improved sleep-related symptoms by >30%, including insomnia and restorative sleep, while alleviating nighttime and morning motor symptoms. It significantly reduced NMS burden, particularly sleep disturbances and daytime sleepiness, indicating its potential to address both motor and non-motor challenges in PD patients with wearing-off, sleep-related disturbances and high NMS burden.

Authors/Disclosures
Ghazal Banisadr, PhD (Amneal Pharmaceuticals) PRESENTER	Dr. Banisadr has received personal compensation for serving as an employee of Amneal Pharmaceuticals.
Miguel F. Gago, MD, PhD (Hospital da Senhora da Oliveira, Guimarães)	Prof. Gago has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bial. Prof. Gago has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Prof. Gago has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Zambon.
Raquel Costa, PharmD, SpLM	Dr. Costa has nothing to disclose.
Helena Brigas, PhD	Dr. Brigas has received personal compensation for serving as an employee of BIAL.
Bruno F. Santos, MD	Dr. Santos has received personal compensation for serving as an employee of Bial.
Joerg Holenz, PhD	Mr. Holenz has received personal compensation for serving as an employee of BIAL. Mr. Holenz has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for BIAL RD Investments. Mr. Holenz has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for BIAl Portela SA. Mr. Holenz has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for BIAL Biotech . Mr. Holenz has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Wiley. Mr. Holenz has stock in Astra Zeneca. Mr. Holenz has received intellectual property interests from a discovery or technology relating to health care.
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.

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