To assess whether converting patients with Parkinson’s disease (PD) to CREXONT improves Parkinson’s Disease Sleep Scale-2 (PDSS-2) total and sub-scale scores.

CREXONT is a novel extended-release, oral carbidopa-levodopa (CD-LD) formulation that improves LD pharmacokinetics. In the RISE-PD trial, CREXONT was dosed 2-4 times per day and demonstrated a significant increase vs immediate-release (IR) CD-LD in “Good On” time per day and “Good On” time per dose. Since sleep-related issues are among the most troublesome and common non-motor symptoms in PD, we evaluated PDSS-2 scores in patients after converting to CREXONT in the RISE-PD clinical trial.

RISE-PD was a 20-week, phase 3 study consisting of a 3-week open-label IR CD-LD dose optimization phase, then a 4-week open-label dose conversion phase to CREXONT, followed by a 13-week, randomized, double-blind, double-dummy maintenance phase with two parallel arms: IR CD-LD and CREXONT. The current analysis included all patients who successfully converted to CREXONT. Outcome measures included changes in PDSS-2 total and sub-scale scores from study entry to the end of the CREXONT dose conversion period.

Of the 506 patients who completed conversion to CREXONT, there was a statistically significant improvement in the PDSS-2 total score (mean difference of -2.35, p<0.01) from study entry to the end of dose-conversion. Notably, patients experienced significant improvements in all subdomains, including a reduction in disturbed sleep (-1.07, p<0.01), motor symptoms at night (-0.62, p<0.01), and PD symptoms at night (-0.65, p<0.01).

Conversion to CREXONT significantly improved sleep quality in PD patients, as measured by PDSS-2, addressing both sleep disturbances and nighttime motor symptoms.