Abstract Details

Title Safety and Tolerability in Parkinson’s Disease Patients Treated with a Continuous Subcutaneous Infusion of ABBV-951: Design of a 52-Week Phase 3 Study

Topic Movement Disorders

Presentation(s) P9 - Poster Session 9 (12:00 PM-1:00 PM)

Poster/Presentation
Number 3-005

Objective To assess the local and systemic safety and tolerability of ABBV-951 delivered as a continuous subcutaneous infusion (CSCI) for 24 hours daily for up to 52 weeks in Parkinson’s disease (PD) patients.

Background ABBV-951 is a new soluble formulation of carbidopa and levodopa prodrugs being developed for the treatment of PD. This Phase 3, open-label, single-arm study examines the 52-week safety and tolerability of ABBV-951 in PD patients in an outpatient setting (NCT03781167).

Design/Methods Approximately 130 patients (≥30 years of age) with idiopathic PD will be enrolled across 65 global study sites. Eligibility criteria include PD patients who are levodopa-responsive, have a minimum of 2.5 hours of OFF time/day, and are inadequately controlled by current oral therapies. The study consists of three periods: screening (up to 42 days), dose optimization (4 weeks), and maintenance (48 weeks). Study visits will occur weekly during the optimization period and at weeks 6, 13, 26, 39, and 52 during the maintenance period.

Results The primary objective is to assess the local and systemic safety and tolerability of ABBV-951 during CSCI administration. Local and systemic safety and tolerability will be assessed using the Infusion Site Evaluation Scale and adverse event monitoring, respectively. Exploratory efficacy will be evaluated by changes in OFF time using PD diaries and changes in PD symptoms using the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS).

Conclusions ABBV-951 has the potential to provide a non-surgical treatment option for patients with PD whose motor complications are inadequately controlled by oral medications. The current study is designed to assess the 52-week safety and tolerability of personally titrated therapeutic doses of ABBV-951 continuously infused in PD patients in an outpatient setting.

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.
Janet Benesh, BSMT (Abbott Laboratories)	No disclosure on file
Janet Streit (AbbVie)	No disclosure on file
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.
Cindy Zadikoff, MD (AbbVie)	Dr. Zadikoff has received personal compensation for serving as an employee of AbbVie.
David G. Standaert, MD, PhD, F�鶹��ýӳ�� (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 �鶹��ýӳ�� interests or activities.

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