Abstract Details

Title Improvement of “On” and “Off” Times in Patients with Advanced Parkinson’s Disease Treated with Foslevodopa/Foscarbidopa: Subgroup Analyses from a Phase 3 Randomized Study

Topic Movement Disorders

Presentation(s) S30 - Movement Disorders: Clinical Trials in Movement Disorders (2:12 PM-2:24 PM)

Poster/Presentation
Number 007

Background

As PD progresses, motor fluctuations and dyskinesias become more challenging to control with oral levodopa. LDP/CDP is a new, soluble formulation of LD/CD prodrugs delivered as a 24-hour/day continuous subcutaneous infusion. In a phase 3 study, LDP/CDP significantly increased “On” time and reduced “Off” time vs oral LD/CD.

Objective To compare the efficacy of subcutaneous foslevodopa/foscarbidopa (LDP/CDP) with oral levodopa/carbidopa (LD/CD) across prespecified subgroups of patients with advanced Parkinson’s disease (PD) in a phase 3 study.

Design/Methods A prespecified subgroup analysis was conducted in patients with advanced PD from a phase 3, randomized, double-blind, active-controlled study (NCT04380142) who received LDP/CDP or oral LD/CD for 12 weeks. The change from baseline to final visit in “On” time without dyskinesia, “On” time without troublesome dyskinesia, and “Off” time were evaluated in patient subgroups: age (<65 or ≥65 years), sex, race (White or other), country (United States or Australia), PD duration (<10 or ≥10 years), and concomitant dopamine agonist use. “On” and “Off” times were normalized to a 16-hour waking day and summarized by least squares means (LSM) calculated through analysis of covariance.

Results This analysis included 139 patients (LDP/CDP, N=73; oral LD/CD, N=66). Patients aged <65 years receiving LDP/CDP compared with oral LD/CD showed significant improvement from baseline to last evaluation in “On” time without troublesome dyskinesia (LSM [SE] 3.5 [0.7] hours vs 0.5 [0.7] hours; P=.003); patients aged ≥65 years showed numerical improvements (1.7 [0.5] hours vs 1.0 [0.5] hours). In all other subgroups, patients receiving LDP/CDP compared with oral LD/CD showed greater numerical improvements in “On” time without dyskinesia, “On” time without troublesome dyskinesia, and “Off” time. No significant differences in treatment effects were observed between any of the subgroups.

Conclusions Patients experienced greater benefits with LDP/CDP vs oral LD/CD across all subgroups. No significant differences in treatment response were evident in any subgroup.

Authors/Disclosures
Drew S. Kern, MD, FAAN (University of Colorado) PRESENTER	Dr. Kern has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic. The institution of Dr. Kern has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Scientific. The institution of Dr. Kern has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Kern has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbott. The institution of Dr. Kern has received research support from Boston Scientific. The institution of Dr. Kern has received research support from AbbVie Pharmaceticals. Dr. Kern has received research support from Medtronic.
Robert A. Hauser, MD, MBA, FAAN (Movement Disorders Center)	Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Global Kinetics Consulting (GKC). Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Jazz Pharmaceuticals. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Kyowa Kirin Pharmaceuticals. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurocrine Biosciences. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NeuroDerm. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Scion Neurostim LLC. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sunovion Pharmaceuticals. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Tolmar Inc.. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Revance Therapeutics. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Supernus Pharma. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Inhibikase. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pharma 2 B. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Vivifi Biotech. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sage Therapeutics. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Orion. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Ovid Therapeutics. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Amneal. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for AgeX Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avanex. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BlueRock Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MDCE Suzhou. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MedRhythms. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PDNeurotechnology. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Regenxbio. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Tremor Research Support Group. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Tris Pharma. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for UCB. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Inhibikase. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Acorda Therapeutics. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Ameal . Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Kyowa Kirin. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Neurocrine. Dr. Hauser has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Sunovion. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Cerevel. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Inhibikase. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Supernus. Dr. Hauser has stock in Inhibikase. Dr. Hauser has stock in Axial Therapeutics. Dr. Hauser has stock in Enterin. Dr. Hauser has stock in Revance Therapeutics. The institution of Dr. Hauser has received research support from Annovis Bio, Inc.. The institution of Dr. Hauser has received research support from Artizan Biosciences. The institution of Dr. Hauser has received research support from Parkinsons & Movement Disorder Alliance. The institution of Dr. Hauser has received research support from Inhibikase Therapeutics. The institution of Dr. Hauser has received research support from AbbVie, Inc.. The institution of Dr. Hauser has received research support from Aeon Biopharma. The institution of Dr. Hauser has received research support from Biogen MA. The institution of Dr. Hauser has received research support from Bukwang Pharmaceutical Co., Ltd.. The institution of Dr. Hauser has received research support from Cavion, Inc.. The institution of Dr. Hauser has received research support from Cerevance Beta, Inc.. The institution of Dr. Hauser has received research support from Cerevel Therapeutics. The institution of Dr. Hauser has received research support from Cynapsus Therapeutics. The institution of Dr. Hauser has received research support from Enterin, Inc.. The institution of Dr. Hauser has received research support from Genentech. The institution of Dr. Hauser has received research support from Global Kinetics Corporation. The institution of Dr. Hauser has received research support from Hoffman-La Roche Inc. The institution of Dr. Hauser has received research support from Impax Labratories. The institution of Dr. Hauser has received research support from Integrative Research Labratories Sweden. The institution of Dr. Hauser has received research support from Lundbeck, Inc.. The institution of Dr. Hauser has received research support from Michael J. Fox Foundation for Parkinson's Research. The institution of Dr. Hauser has received research support from National Parkinson's Foundation. The institution of Dr. Hauser has received research support from Neuraly Inc.. The institution of Dr. Hauser has received research support from Neurocrine Biosciences. The institution of Dr. Hauser has received research support from Neuroderm. The institution of Dr. Hauser has received research support from Pharma Two B Ltd.. The institution of Dr. Hauser has received research support from Revance Therapeutics. The institution of Dr. Hauser has received research support from Sage Therapeutics. The institution of Dr. Hauser has received research support from Sanofi Pharmaceuticals. The institution of Dr. Hauser has received research support from Scion NeuroStim. The institution of Dr. Hauser has received research support from SunPharma. The institution of Dr. Hauser has received research support from UCB BioPharma. Dr. Hauser has received intellectual property interests from a discovery or technology relating to health care.
Thomas E. Kimber, PhD, FRACP (Royal Adelaide Hospital)	Dr. Kimber has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Kimber has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Kimber has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva. Dr. Kimber 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. Kimber has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Seqiris. Dr. Kimber has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie. Dr. Kimber has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Pfizer.
Okeanis Vaou, MD, FAAN (UT Health San Antonio)	An immediate family member of Dr. Vaou has received personal compensation for serving as an employee of Acadia Pharmaceutical. An immediate family member of Dr. Vaou has received personal compensation for serving as an employee of Sage. Dr. Vaou has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbott. Dr. Vaou has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Vaou has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medtronic . Dr. Vaou has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for medtronic. An immediate family member of Dr. Vaou has stock in Takeda and Acadia, Sage. The institution of Dr. Vaou has received research support from Medtronic.
Lars Bergmann	Lars Bergmann has received personal compensation for serving as an employee of Abbvie. Lars Bergmann has stock in Abbvie.
Resmi Gupta (Abbvie Inc)	No disclosure on file
Anna Jeong, MD (AbbVie)	Dr. Jeong has received personal compensation for serving as an employee of AbbVie. An immediate family member of Dr. Jeong has received personal compensation in the range of $500,000-$999,999 for serving as a Consultant for Stryker. Dr. Jeong has stock in AbbVie.
Jia Jia, PhD	Mr. Jia has received personal compensation for serving as an employee of Abbvie.
Megha Shah	Megha Shah has received personal compensation for serving as an employee of AbbVie. Megha Shah has stock in AbbVIe .
Michael Soileau, MD, FAAN (Texas Movement Disorder Specialists, PLLC)	The institution of Dr. Soileau has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbott. The institution of Dr. Soileau has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Medtronic. The institution of Dr. Soileau has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. The institution of Dr. Soileau has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Supernus. The institution of Dr. Soileau has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neurocrine PHarmaceuticals. The institution of Dr. Soileau has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal Pharmaceuticals. Dr. Soileau has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Abbvie. Dr. Soileau has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amneal. Dr. Soileau has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Kyowa Kiran. The institution of Dr. Soileau has received research support from Abbvie. The institution of Dr. Soileau has received research support from Cerevel. The institution of Dr. Soileau has received research support from Praxis. The institution of Dr. Soileau has received research support from CND Life Sciences. The institution of Dr. Soileau has received research support from Teva. The institution of Dr. Soileau has received research support from Abbott. The institution of Dr. Soileau has received research support from Jazz Pharmaceuticals. The institution of Dr. Soileau has received research support from Scion. Dr. Soileau has received publishing royalties from a publication relating to health care.