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Abstract Details

Sustained Long-term Safety and Tolerability of Foslevodopa/Foscarbidopa in Parkinson's Disease: 96-week Primary Treatment Period Results from an Ongoing Open-label Extension Study
Movement Disorders
P11 - Poster Session 11 (8:00 AM-9:00 AM)
5-006
Evaluate the long-term safety, tolerability, and efficacy of foslevodopa/foscarbidopa (LDp/CDp) in people with advanced Parkinson's disease (PD) treated through week 96 of an open-label extension study (OLES).
LDp/CDp 24-hour/day continuous subcutaneous infusion reduced motor fluctuations and showed a favorable risk/benefit profile in patients with PD in a 52-week(W), open-label, phase 3 study (NCT03781167). Patients who completed the parent study were eligible for this OLES (NCT04379050).
The parent study enrolled adults with idiopathic levodopa-responsive PD and inadequately controlled motor fluctuations. The OLES comprised a 96W primary treatment period (PTP) and an optional extended treatment period (ETP). LDp/CDp base infusions were individually optimized between 600–4250 mg LD equivalents/24h. The primary endpoint was safety/tolerability. Secondary endpoints included change in daily normalized "Off" and "On" time and morning akinesia (awakening in the "Off" state). All patients have reached the PTP W96 final visit for this planned interim analysis (data cutoff May 15, 2024). Efficacy data are presented through W96; safety reporting includes the PTP and ETP.
Of 129 patients in the OLES, 96 (74.4%) completed the 96W PTP; the most common reason for discontinuation was adverse event (AE, n=13[10.3%]). At OLES baseline, the mean(SD) LDp/CDp total daily dose was 1098.3[747.7] mg/day, and at 96W was 2002.9(770.5) mg/day. Treatment-related improvements in "On" and "Off" time and morning akinesia observed during the parent study were generally sustained through the OLES: mean [SD] changes from OLES baseline to W96 (n=81) in "On" time without troublesome dyskinesia (-0.6[3.2] hours, P=.090) and "Off" time (0.7[3.0] hours, P=0.58). At OLES W96, 24.1% of patients reported morning akinesia; 77.7% reported morning akinesia before LDp/CDp initiation in the parent study. Overall, 92.2% of patients experienced ≥1 AE in the OLES.

LDp/CDp showed favorable long-term safety/tolerability with sustained efficacy through OLES W96 (total treatment of 148W including the 52W parent study).
Authors/Disclosures
Jason L. Aldred, MD, FAAN (Selkirk Neurology)
PRESENTER 		Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Scientific. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allergan . Dr. Aldred has received personal compensation in the range of $0-$499 for serving as a Consultant for Quadralynx. Dr. Aldred 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. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Boston Scientific. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medtronic. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Acorda. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan. Dr. Aldred has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Boston Scientific. Dr. Aldred has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for TEVA. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Medtronic. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for US World Meds. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Kyowa Kirin. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sunovion. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amneal. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 for serving as an Expert Witness for Arete Neuroscience, PLLC. The institution of Dr. Aldred has received research support from Biogen . The institution of Dr. Aldred has received research support from Abbvie. The institution of Dr. Aldred has received research support from Merz. The institution of Dr. Aldred has received research support from AstraZeneca. The institution of Dr. Aldred has received research support from Neurocrine. The institution of Dr. Aldred has received research support from Aptinyx. The institution of Dr. Aldred has received research support from Cerevance. The institution of Dr. Aldred has received research support from Boston Scientific . The institution of Dr. Aldred has received research support from Parkinson Foundation . The institution of Dr. Aldred has received research support from Roche. The institution of Dr. Aldred has received research support from Sage Therapeutics. The institution of Dr. Aldred has received research support from Annovis. The institution of Dr. Aldred has received research support from Biovie. The institution of Dr. Aldred has received research support from NeuroDerm. The institution of Dr. Aldred has received research support from PhotoPharma. The institution of Dr. Aldred has received research support from Lilly.
Filip Bergquist The institution of Filip Bergquist has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie. Filip Bergquist has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for Arvid Carlsson Research AB. The institution of Filip Bergquist has received research support from Swedish Government. The institution of Filip Bergquist has received research support from Parkinsonfonden. The institution of Filip Bergquist has received research support from Neuro Sweden. The institution of Filip Bergquist has received research support from Swedish Research Council. Filip Bergquist has received publishing royalties from a publication relating to health care. Filip Bergquist has received publishing royalties from a publication relating to health care. Filip Bergquist has a non-compensated relationship as a Advisor with Sense4Care that is relevant to AAN interests or activities.
Erik H. Danielsen, MD, PhD Dr. Danielsen has nothing to disclose.
Camille Carroll, MD (University of Plymouth Faculty of Medicine and Dentistry) The institution of Dr. Carroll has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. The institution of Dr. Carroll has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. The institution of Dr. Carroll has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bial. The institution of Dr. Carroll has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Global Kinetic. The institution of Dr. Carroll has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Scient. The institution of Dr. Carroll has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Kyowa Kirin. The institution of Dr. Carroll has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Medscape. The institution of Dr. Carroll has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bial. The institution of Dr. Carroll has received research support from Parkinson's UK. The institution of Dr. Carroll has received research support from Edmond J Safra Foundation. The institution of Dr. Carroll has received research support from Cure Parkinson's. The institution of Dr. Carroll has received research support from Parkinson's UK. The institution of Dr. Carroll has received research support from NHSX.
Cheney Matthews No disclosure on file
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 .
Amy M. Spiegel, PhD (AbbVie) Amy Spiegel has received personal compensation for serving as an employee of AbbVie. Amy Spiegel has received stock or an ownership interest from AbbVie.
Victor Fung, MD, MBBS, PhD Dr. Fung 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. Fung has received publishing royalties from a publication relating to health care.