Objective: To explore the effects of IPX203 on nighttime sleep and motor states in patients with Parkinson’s disease (PD) experiencing motor fluctuations.

Background: Sleep disturbances affect up to 80% of PD patients and are related to both motor (nighttime “Off”) and nonmotor (sleep fragmentation, sleep quality) symptoms. In the RISE-PD trial, IPX203 treatment was associated with a significant increase in “Good On” time per day and “Good On” time per dose when compared to immediate-release (IR) CD-LD. This post hoc analysis investigates the effects of IPX203 on sleep patterns and nighttime motor states.

Method: RISE-PD had three consecutive phases: a 3-week open-label IR CD-LD dose adjustment, a 4-week open-label dose conversion to IPX203, and a 13-week, randomized, double-blind maintenance period with one arm per formulation. For this analysis, we used Hauser diary data from the 506 subjects that completed the open-label phase of RISE-PD. Sleep interruptions and awake times were quantified, along with the prevalence of “Off” before sleep, “Off” during the nighttime sleep period (ODNSP), and early morning “Off” (EMO). Values were analyzed at study entry (Visit 1), end of IR CD-LD dose adjustment (Visit 2), and end of IPX203 dose conversion (Visit 4). The effect of treatment epochs on the above metrics was tested with repeated-measure t tests.

Results: Compared to study entry, treatment with IPX203 was associated with a significant reduction in the average number of sleep period awakenings, going from 0.35 at study entry to 0.26 at end of IPX203 conversion (-26%, p=0.01). The prevalence of “Off” episodes decreased before sleep (-17%, p=0.0002), during the nighttime sleep period (-11%, p=0.002) and in the early morning (-23%, p=0.0001). The average duration of “Off” episodes was also reduced from 0.34h to 0.18h (-47%, p=0.03) for ODNSP and from 1.28h to 0.93h (-27%, p=0.006) for EMO.

Conclusion: Treatment with IPX203 resulted in significant improvements in sleep in patients with PD as evidenced by decreased prevalence and duration of awakenings during the night. In addition, overnight and early morning motor control was improved, as the prevalence and duration of ODNSP and EMO were significantly decreased. By addressing nighttime levodopa delivery, IPX203 may enhance overall quality of sleep and nighttime symptom control.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/impact-of-ipx203-er-cd-ld-on-nighttime-sleep-in-patients-with-parkinsons-disease-experiencing-motor-fluctuations-a-post-hoc-analysis-of-the-rise-pd-trial/