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.