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Abstract Details

Efficacy and Safety of Foslevodopa/Foscarbidopa Versus Oral Carbidopa/Levodopa in Advanced Parkinson’s Disease Patients: Design of a Phase 3, Randomized, Double-Blind, Double-Dummy, Active Controlled 12-Week Trial
Movement Disorders
Movement Disorders Posters (7:00 AM-5:00 PM)
139
Efficacy and Safety of Foslevodopa/Foscarbidopa Versus Oral Carbidopa/Levodopa in Advanced Parkinson’s Disease Patients: Design of a Phase 3, Randomized, Double-Blind, Double-Dummy, Active Controlled 12-Week Trial
As PD progresses, oral drug regimens may become insufficient for symptom control. Foslevodopa/foscarbidopa, formally known as ABBV-951, is a new soluble formulation of carbidopa and levodopa prodrugs being developed for the treatment of advanced PD delivered as a CSCI via a portable external pump.
This phase 3, randomized, double-blind, double-dummy, parallel-group, active-controlled, multicenter study includes patients (≥30 years) whose motor symptoms are no longer adequately controlled by their current therapy and experience a minimum daily average of 2.5h of “Off” time per day (with a minimum of 2.0h each day). The study is comprised of a screening period, and an oral CD/LD stabilization period, followed by randomization into the 12-week double-blind treatment period. Patients will receive either 24-hour/day CSCI of foslevodopa/foscarbidopa plus oral placebo or 24-hour/day CSCI of placebo solution plus oral CD/LD. Assessments include the change from baseline to Week 12 in "On" and “Off” times from PD Diaries, MDS-UPDRS scores, quality of life, sleep symptoms, and PD symptoms measured using a wearable device. Local and systemic safety and tolerability will be assessed using the Infusion Site Evaluation Scale and adverse event monitoring.
This study will enroll approximately 130 advanced PD patients from an estimated 80 sites in the United States and Australia (clinicaltrials.gov ID: NCT04380142)
This study will provide important data on the safety and efficacy of foslevodopa/foscarbidopa, a potentially new advanced treatment option, delivered 24-hour/day via CSCI versus oral CD/LD in advanced PD patients.
Authors/Disclosures
Maurizio Facheris, MD, MSc (Vanqua Bio, Inc)
PRESENTER 		Dr. Facheris has received personal compensation for serving as an employee of Vanqua Bio. Dr. Facheris has or had stock in Vanqua Bio.
Weining Robieson, PhD (AbbVie) Dr. Robieson has received personal compensation for serving as an employee of AbbVie. Dr. Robieson has received stock or an ownership interest from AbbVie.
Nahome Fisseha Nahome Fisseha has received personal compensation for serving as an employee of AbbVie. Nahome Fisseha has received stock or an ownership interest from AbbVie.
David G. Standaert, MD, PhD, FÂ鶹´«Ã½Ó³»­ (Univ of Alabama - Dept of Neurology) Dr. Standaert has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie, Inc. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Curium. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alnylam. Dr. Standaert has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biohaven. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CVS/Pharmacy. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for HanAll Biopharma. Dr. Standaert has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Eli Lilly. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for F. Hoffman LaRoche. Dr. Standaert has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi-Aventis. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Theravance, Inc. Dr. Standaert 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 International Parkinson and Movement Disorder Society. The institution of Dr. Standaert has received research support from Abbvie, Inc. The institution of Dr. Standaert has received research support from American Parkinson Disease Association. The institution of Dr. Standaert has received research support from National Institutes of Health. The institution of Dr. Standaert has received research support from F. Hoffman LaRoche. Dr. Standaert has received publishing royalties from a publication relating to health care. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Reviewer with National Institutes of Health. Dr. Standaert has a non-compensated relationship as a Chair, Scientific Advisory Board with American Parkinson Disease Association that is relevant to Â鶹´«Ã½Ó³»­ interests or activities.