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Abstract Details

Long-term Safety and Tolerability of Foslevodopa/Foscarbidopa for Treatment of Motor Fluctuations in Parkinson’s Disease
Movement Disorders
P9 - Poster Session 9 (8:00 AM-9:00 AM)
3-008

LDp/CDp is a soluble formulation of levodopa (LD)/carbidopa prodrugs delivered as a 24-hour/day CSCI for the treatment of motor fluctuations in PD. LDp/CDp demonstrated a favorable risk/benefit profile in a 52-week, open-label phase 3 study (NCT03781167); patients who completed the parent trial could enroll in the OLES (NCT04379050).

A phase 3 open-label extension study (OLES) to evaluate long-term safety/tolerability of continuous subcutaneous infusion (CSCI) of foslevodopa/foscarbidopa (LDp/CDp) in patients with Parkinson’s disease (PD).

LD-responsive PD patients with inadequately controlled (≥2.5 hours “Off” time/day) motor symptoms were enrolled in the parent study and continued into the ongoing OLES. LDp/CDp infusions are individually optimized (600–4250 mg LD equivalents/24 hours). Safety/tolerability is the primary endpoint. Key secondary endpoints include change from OLES baseline for mean normalized daily “Off” and “On” times, morning akinesia (“Off” upon awakening), and quality of life (QoL) scores (PDQ-39 and EQ-5D-5L). Efficacy data are presented through Week 84 (interim data cutoff August 17,2022).
A total of 129 (94.2%) patients enrolled in the OLES and few have discontinued (16 [12.4%]). Mean (SD) and maximum exposure duration are 470.1(386.9) and 1169 days, respectively. Overall, 83.7% of patients experienced ≥1 AE; most were non-serious and mild/moderate in severity. “On” and “Off” times were generally stable from entry into the OLES through Week 84 (change from OLES baseline in “On” time without troublesome dyskinesia: −0.6[2.9] hours, P=.252; “On” time with troublesome dyskinesia: −0.2[1.2] hours, P=.364; “Off” time: 0.9[2.7] hours, P=.102). Most patients (75%) reported awakening in the “On” state (n/N=15/20) at Week 84. The improvement in the parent study on PDQ-39 and EQ-5D-5L scores was maintained from OLES baseline to Week 72. 
Long-term LDp/CDp was generally safe and well tolerated. Treatment-related improvements in motor fluctuations, morning akinesia, and QoL observed at the conclusion of the 52-week parent study were maintained throughout the OLES.
Authors/Disclosures
Maurizio F. Facheris, MD, MSc (Abbvie Inc)
PRESENTER
Dr. Facheris has received personal compensation for serving as an employee of AbbVie Inc.. Dr. Facheris has stock in AbbVie Inc..
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.
Filip Bergquist Filip Bergquist has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. 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.
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.
No disclosure on file
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.
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.
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.
Jason L. Aldred, MD, FAAN (Selkirk Neurology) Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Medtronic. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Boston Scientific. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Abbvie. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen . Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allergan . Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Quadralynx. Dr. Aldred 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. 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 Boston Scientific. 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 Medtronic. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Abbvie. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Adamas. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Allergan. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 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 $10,000-$49,999 for serving on a Speakers Bureau for Medtronic. Dr. Aldred has received personal compensation in the range of $5,000-$9,999 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 $5,000-$9,999 for serving on a Speakers Bureau for Biogen. Dr. Aldred has received personal compensation in the range of $100,000-$499,999 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 Atara. The institution of Dr. Aldred has received research support from Takeda. 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 Theravance. The institution of Dr. Aldred has received research support from Triplet Therapeutics. The institution of Dr. Aldred has received research support from UCB. The institution of Dr. Aldred has received research support from Cerevel . 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 Athira. The institution of Dr. Aldred has received research support from IRL. The institution of Dr. Aldred has received research support from NeuroDerm.