Objective: To evaluate “On” upon awakening in Parkinson’s disease patients taking IPX203 in the RISE-PD phase 3 clinical trial.

Background: IPX203 is a novel extended-release, oral carbidopa-levodopa (CD-LD) formulation that provides fast onset and prolonged duration of “On”. In the RISE-PD trial, IPX203 was dosed 2-4 times per day and demonstrated significant increase vs immediate-release (IR) CD-LD in “Good On” time per day and “Good On” time per dose.

Method: We performed an analysis of Hauser diary data from the 495 subjects that completed the RISE-PD study (mITT analysis set). The study had a 3-week open-label IR CD-LD dose adjustment phase and a 4-week open-label dose conversion phase to IPX203, followed by a 13-week, randomized, double-blind, double-dummy maintenance phase with two parallel arms: IR CD-LD and IPX203. Hauser 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 IPX203 dose conversion period), 10, 15, and 20 (end of study [EOS]). Outcome measures evaluated over the three days prior to the 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 IPX203 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 IPX203 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 IPX203 vs 71% to 59% for IR CD-LD (p=0.0067).

Conclusion: IPX203 treatment resulted in significant increase in patients waking up “On” during the study period. At EOS, a significantly higher percentage of patients on IPX203 were never “Off” upon awakening compared to patients on IR CD-LD. In addition, significantly less patients reported to never be “On” upon awakening in the IPX203 group vs IR CD-LD.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/impact-of-ipx203-on-parkinsons-patients-motor-states-upon-awakening-analysis-of-patient-diary-data/