Objective:

To evaluate “On” upon awakening in Parkinson’s disease patients taking CREXONT in the RISE-PD phase 3 clinical trial.

Background:

CREXONT is a novel extended-release, oral carbidopa-levodopa (CD-LD) formulation that provides fast onset and prolonged duration of “On”. In RISE-PD, CREXONT demonstrated significant increase vs immediate-release (IR) CD-LD in “Good On” time per day and “Good On” time per dose.

Design/Methods:

We performed an analysis of Hauser diary data from the 495 subjects that completed the RISE-PD study. Diary data recorded patients' motor states in 30-minute intervals over 3 days at study entry and weeks 3 (end of IR CD-LD dose adjustment period), 7 (end of CREXONT dose conversion period), 10, 15, and 20 (end of study [EOS]). Outcome measures evaluated over the three days prior to study visit: the percentage of times waking up “On” (“On” upon awakening), the percentage of patients that never recorded “Off” upon awakening, and the percentage of patients that never recorded “On” upon awakening.

Results:

At study entry, patients reported waking up “On” 17% of the time. At EOS, “On” upon awakening was 40% in patients on CREXONT vs 27% in patients on IR CD-LD (p=0.0004). At study entry, 8% of patients never recorded “Off” upon awakening. At EOS, 26% of patients on CREXONT never recorded “Off” upon awakening vs 17% in the IR CD-LD group (p=0.0224). Additionally, the percentage of patients that never recorded “On” upon awakening decreased from 73% to 47% with CREXONT vs 71% to 59% for IR CD-LD (p=0.0067).

Conclusions:

CREXONT treatment resulted in significant increase in patients waking up “On” during the study period. At EOS, a significantly higher percentage of patients on CREXONT were never “Off” upon awakening vs patients on IR CD-LD. Significantly lower percentage of patients recorded to never be “On” upon awakening in the CREXONT group vs IR CD-LD.