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Abstract Details

Effects of Continuous Subcutaneous Infusion of Foslevodopa/Foscarbidopa on Sleep Dysfunction in People with Parkinson's
Movement Disorders
P9 - Poster Session 9 (8:00 AM-9:00 AM)
3-005
Assess whether 24-hour/day continuous subcutaneous infusion (CSCI) of foslevodopa/foscarbidopa (LDp/CDp) improves Parkinson’s Disease Sleep Scale-2 (PDSS-2) subdomains in people with Parkinson’s (PwP).
Sleep is commonly disrupted in PwP. The PDSS-2 provides a Total Score (TS) and subdomain scores for: Motor Symptoms at Night (MS), Parkinson’s Disease Symptoms at Night (PDS), and Disturbed Sleep (DS). A double-blind 12-week phase 3 trial of LDp/CDp CSCI versus levodopa-carbidopa immediate-release (LD/CD-IR) oral tablets (NCT04380142) suggested improvements in the intention-to-treat (ITT) population PDSS-2 TS. An open-label 52-week phase 3 trial of LDp/CDp CSCI (NCT03781167) demonstrated significant improvements in PDSS-2 TS and all subdomains versus baseline in patients completing 52 weeks.
Here the 12- and 52-week trials’ ITT PDSS-2 subdomains and TS change from baseline were evaluated post hoc between treatments and within groups. P values are nominal and not corrected for multiplicity.
Analysis revealed improvements in the 12-week LDp/CDp-treated patients (n=44) MS subdomain (LS mean of difference [SE]: -1.97 [0.54]***), DS subdomain (-2.62 [0.67]***), and TS (-5.40 [1.32]***) versus oral LD/CD-IR (n=59; nominal ***P≤.001). Additionally, within-group improvements versus baseline were seen in the 12-week oral-treated patients for PDS subdomain (mean [SD]: -0.64 [2.20]*) and TS (-1.64 [6.22]*; *P≤.05), in the 12-week LDp/CDp-treated patients subdomains (MS -3.09 [3.18]***, PDS -1.84 [3.32]***, DS -3.41 [4.40]***) and TS (-8.34 [8.86]***), and in the 52-week ITT patients (N=200) subdomains (MS -1.5 [4.77]***, PDS -1.9 [4.44]***, DS -2.4 [4.67]***) and TS (-5.9 [10.85]***; ***P≤.001). Soileau et al. and Aldred et al. previously reported 12- and 52-week LDp/CDp CSCI to be well-tolerated and generally safe.
These post hoc results demonstrate numerical improvement in two-of-three 12-week trial subdomains and TS in LDp/CDp versus oral (nominal P≤.001), and significant within-group improvements in all three subdomains and TS of the 12- and 52-week LDp/CDp ITT populations, suggesting CSCI of LDp/CDp improves sleep in PwP.
Authors/Disclosures
Robert A. Hauser, MD, MBA, FÂ鶹´«Ã½Ó³»­ (Movement Disorders Center)
PRESENTER 		Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Supernus. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Stoparkinson. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Revance. Dr. Hauser has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Abbvie. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neurocrine. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mitsubishi Tanabe. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amneal. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Intrance. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zambon. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for NanoPharmasolutions. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for HanAll BioPharma. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Cerevance. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Clario. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for ABLi Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sumitomo. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Taurus Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sorriddi Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Contera. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alterity Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Convatec Inc. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Knight Therapeutics. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acadia. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biorasi. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medicure Pharma. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BlueRock. 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. The institution of 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 Stoparkinson. The institution of Dr. Hauser has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Photopharmics. The institution of Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ABLi Therapeutics. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amneal . Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Neurocrine Biosciences. Dr. Hauser has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Supernus. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie. Dr. Hauser has or had stock in Inhibikase.Dr. Hauser has or had stock in Axial Therapeutics.Dr. Hauser has or had stock in Enterin.Dr. Hauser has or had stock in Photopharmics. The institution of Dr. Hauser has received research support from Annovis Bio, Inc.. 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 Biogen MA. 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 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 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 Neuroderm. The institution of Dr. Hauser has received research support from Sage Therapeutics. The institution of Dr. Hauser has received research support from Scion NeuroStim. The institution of Dr. Hauser has received research support from UCB BioPharma. The institution of Dr. Hauser has received research support from UCB. The institution of Dr. Hauser has received research support from Amneal Pharmaceuticals. The institution of Dr. Hauser has received research support from Motric Bio, Inc.. The institution of Dr. Hauser has received research support from Sun Pharma Advanced Research Company. The institution of Dr. Hauser has received research support from Teva Branded Pharmaceuticals. The institution of Dr. Hauser has received research support from Truebinding, Inc.. The institution of Dr. Hauser has received research support from Jazz Pharmaceuticals. The institution of Dr. Hauser has received research support from Ipsen. Dr. Hauser has received intellectual property interests from a discovery or technology relating to health care.
Bruno Bergmans (AZ St-Jan Brugge) Bruno Bergmans has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbott. Bruno Bergmans has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie Inc.. Bruno Bergmans has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merz GmbH. Bruno Bergmans has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Scientific. The institution of Bruno Bergmans has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie Inc.. The institution of Bruno Bergmans has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merz GmbH. The institution of Bruno Bergmans has received research support from Abbvie Inc.. The institution of Bruno Bergmans has received research support from Merz GmbH. Bruno Bergmans has a non-compensated relationship as a MDS Young Members Group Steering Committee Vice-Chair with International Parkinson and Movement DIsorder Society (MDS) that is relevant to Â鶹´«Ã½Ó³»­ interests or activities.
Irene Malaty, MD, FÂ鶹´«Ã½Ó³»­ (University of Florida) Dr. Malaty has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Malaty has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aevum. The institution of Dr. Malaty has received research support from Abbvie. The institution of Dr. Malaty has received research support from Revance. The institution of Dr. Malaty has received research support from Parkinson Foundation. The institution of Dr. Malaty has received research support from SAGE. The institution of Dr. Malaty has received research support from Emalex. The institution of Dr. Malaty has received research support from Acadia. Dr. Malaty has received publishing royalties from a publication relating to health care. Dr. Malaty has received personal compensation in the range of $500-$4,999 for serving as a Speaker & Center of Excellence Director with Parkinson Foundation. Dr. Malaty has a non-compensated relationship as a MAB member & Center of Excellence Directory with Tourette Association of America that is relevant to Â鶹´«Ã½Ó³»­ interests or activities.
Daniel L. Cobb, MD (The Neurological Center of North Georgia, LLC) Dr. Cobb has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie. Dr. Cobb has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Harmony. Dr. Cobb has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Cook Law Group. The institution of Dr. Cobb has received research support from Harmony. The institution of Dr. Cobb has received research support from Abbvie.
Jaclyn C. Homola, PharmD (AbbVie) Dr. Homola has received personal compensation for serving as an employee of AbbVie. Dr. Homola has stock in AbbVie.
Lars Bergmann, MD (Abbvie GmbH & Co) Dr. Bergmann has received personal compensation for serving as an employee of Abbvie. Dr. Bergmann has or had stock in Abbvie.
Resmi Gupta (Abbvie Inc) Resmi Gupta has nothing to disclose.
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 .
Kallol R. Chaudhuri, MD, FRCP Dr. Chaudhuri has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie, Acadia, GSK, Scion, Britannia , Lobsor. Dr. Chaudhuri 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, Britannia, Scion, Sunovion, UCB, . Dr. Chaudhuri has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie, Britannia, UCB, Zambon. Dr. Chaudhuri 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 NPJ PD journal. The institution of Dr. Chaudhuri has received research support from Britania Pharmaceuticals, AbbVie, UCB, GKC, Bial, Aacdemic grants: EU, IMI EU, Horizon 2020, Parkinson's UK, NIHR, PDNMG, EU (Horizon 2020), Kirby Laing Foundation, NPF, MRC, Wellcome Trust.