Abstract Details

Title Impact of CREXONT on Parkinson’s Patients’ Motor States Upon Awakening: Analysis of Patient Diary Data

Topic Movement Disorders

Presentation(s) P11 - Poster Session 11 (8:00 AM-9:00 AM)

Poster/Presentation
Number 5-010

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.

Authors/Disclosures
Ghazal Banisadr, PhD (Amneal Pharmaceuticals) PRESENTER	Dr. Banisadr has received personal compensation for serving as an employee of Amneal Pharmaceuticals.
Stuart H. Isaacson, MD, FAAN (Parkinson's Dis & Mov Dis Ctr of Boca Raton)	The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acadia. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sunovion. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for acorda. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Supernus. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurocrine. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Kyowa. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for adamas. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neuroderm. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for amneal. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Neurocrine. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for adamas. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Supernus. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acadia. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amneal. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie.
Hubert H. Fernandez, MD, FAAN (Center for Neurological Restoration, Cleveland Clinic)	Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Intrance. Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Fernandez has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier. Dr. Fernandez has received publishing royalties from a publication relating to health care. Dr. Fernandez has received personal compensation in the range of $10,000-$49,999 for serving as a Steering Committee/Advisory Committee Member with Parkinson Study Group.
Camilla Kilbane, MD, FAAN (University Hospitals Cleveland Medical Center)	Dr. Kilbane has received personal compensation in the range of $500-$4,999 for serving as a Consultant for acorda. Dr. Kilbane has received personal compensation in the range of $500-$4,999 for serving as a Consultant for abbvie. Dr. Kilbane has received personal compensation in the range of $500-$4,999 for serving as a Consultant for kyowa kirin. Dr. Kilbane has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medronic. Dr. Kilbane has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for US world Meds. Dr. Kilbane has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for teva. Dr. Kilbane has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Acorda. The institution of Dr. Kilbane has received research support from Abbott.
Arkadiy N. Pitman, Biostatistician	Mr. Pitman has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Amneal.
Stanley Fisher, MD, FAAN	Dr. Fisher has received personal compensation for serving as an employee of Amneal Pharmaceuticals.
Richard D'Souza	Richard DSouza has received personal compensation for serving as an employee of Amneal Pharmaceuticals. Richard DSouza has stock in Amneal Pharmaceuticals .

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