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Abstract Details

Improvement in Morning Akinesia After Foslevodopa/Foscarbidopa Treatment was Associated with Significantly Improved Motor Fluctuations, Activities of Daily Living, and Quality of Life in People with Parkinson’s Disease
Movement Disorders
S37 - Movement Disorders: Clinical Trials (1:36 PM-1:48 PM)
004
MA is one of the most common motor complications in PD, is often an early symptom, and can significantly impair QoL. LDp/CDp 24-hour/day CSCI demonstrated clinically meaningful improvements in MA in 12-week, active-controlled, double-blind, randomized (NCT04380142) and 52-week, single-arm, open-label (NCT03781167) phase 3 clinical trials.
Assessment of morning akinesia (MA) association with motor complications, activities of daily living (ADL), quality of life (QoL), and sleep in patients with advanced Parkinson’s disease (PD) receiving continuous subcutaneous infusion (CSCI) of foslevodopa/foscarbidopa (LDp/CDp).
A post hoc longitudinal approach differentiated LDp/CDp-treated patients with baseline MA pooled from the 12-week active-controlled, 52-week open-label, and a 96-week open-label extension of the active-controlled (NCT04750226; cutoff 14-Sep-2022) trials who demonstrated Continued MA from those who woke up in the “ON” state (Without MA) at Week 12 (wk-12). Efficacy parameters were evaluated via two-sample t-test.
Of the N=93 pooled patients with baseline MA, n=69 (74.2%) changed to Without MA while n=24 (25.8%) patients Continued MA at wk-12. No strong predictors or major differences in baseline characteristics/demographics between groups were observed. Significant differences (*P≤.05, **P≤.01, ***P≤.001) between Without MA versus Continued MA were observed in the mean (SD) change from baseline “ON” Time without Dyskinesia (5.2 [3.81]***, 1.8 [4.42]), “OFF” Time (-4.4 [3.00]***, -0.2 [3.72]), “ON” Time without Troublesome Dyskinesia (4.6 [2.78]***, 0.6 [3.67]), ADL (via MDS-UPDRS Part II, -4.5 [7.39]**, 0.2 [4.82]), and in QoL via PDQ-39 Summary Index (-9.2, [15.59]*, -1.0 [13.10]). While not significant between groups (P=.0645), the Without MA group demonstrated numerically higher clinically meaningful PDSS-2 Total Score improvement (-9.6 [11.15], -4.2 [11.47]). Previously reported overall safety data indicates LDp/CDp is generally well tolerated.
Patients receiving LDp/CDp who changed to waking in the “ON” state experienced: more “ON” Time and less “OFF” Time throughout the day, improved QoL, and increased ability to participate in ADL.
Authors/Disclosures
Rajesh Pahwa, MD, FAAN (University of Kansas Medical Center)
PRESENTER 		Dr. Pahwa has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbott. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Pahwa has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for ACADIA. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amneal. Dr. Pahwa has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Supernus. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Insightec. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jaaz. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Fasikl. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genetech. Dr. Pahwa has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Mitsubishi Tanabe. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Photopharmics. The institution of Dr. Pahwa has received research support from Abbott. The institution of Dr. Pahwa has received research support from Abbvie. The institution of Dr. Pahwa has received research support from Biogen. The institution of Dr. Pahwa has received research support from Parkinson Foundation. The institution of Dr. Pahwa has received research support from Roche. The institution of Dr. Pahwa has received research support from Sage. The institution of Dr. Pahwa has received research support from Sun Pharma. The institution of Dr. Pahwa has received research support from Theravance. The institution of Dr. Pahwa has received research support from Neuroderm. The institution of Dr. Pahwa has received research support from Ask Bio. The institution of Dr. Pahwa has received research support from Blue Rock. The institution of Dr. Pahwa has received research support from Cerevance. The institution of Dr. Pahwa has received research support from Fasikl. The institution of Dr. Pahwa has received research support from Scion. The institution of Dr. Pahwa has received research support from UCB. The institution of Dr. Pahwa has received research support from Ono. The institution of Dr. Pahwa has received research support from Intra-cellular Therapies. The institution of Dr. Pahwa has received research support from Ask Bio. The institution of Dr. Pahwa has received research support from Michael J Fox Foundation . The institution of Dr. Pahwa has received research support from Neuron 23. The institution of Dr. Pahwa has received research support from Roche.
Sara S. Dhanani, MD (Banner Sun Health Research Institute) Dr. Dhanani 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.
Okeanis Vaou, MD, FAAN (UT Health San Antonio) Dr. Vaou has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for ABBVIE. Dr. Vaou has received personal compensation in the range of $10,000-$49,999 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 $10,000-$49,999 for serving on a Speakers Bureau for medtronic. An immediate family member of Dr. Vaou has stock in SAGE. The institution of Dr. Vaou has received research support from Medtronic.
Diego Santos Garcia Diego Santos Garcia has nothing to disclose.
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 AAN interests or activities.
Lars Bergmann, MD No disclosure on file
Linda Harmer, Other (AbbVie) Ms. Harmer has received personal compensation for serving as an employee of AbbVie. Ms. Harmer has stock in AbbVie.
Resmi Gupta (Abbvie Inc) Resmi Gupta has nothing to disclose.
Megha Shah Megha Shah has received personal compensation for serving as an employee of AbbVie. Megha Shah has stock in AbbVIe .
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.
Angelo Antonini, MD Dr. Antonini has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BIAL. Dr. Antonini 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. Antonini has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB. Dr. Antonini has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for THERAVANCE. Dr. Antonini has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ROCHE. Dr. Antonini has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for ABBVIE. Dr. Antonini has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for ZAMBON. Dr. Antonini has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for BOEHRINGER.