Session Information
Date: Monday, September 23, 2019
Session Title: Clinical Trials, Pharmacology and Treatment
Session Time: 1:45pm-3:15pm
Location: Agora 3 West, Level 3
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 investigational drug 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).
Method: 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).
Conclusion: 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.
To cite this abstract in AMA style:
M. Facheris, J. Benesh, J. Streit, W. Robieson, C. Zadikoff, D. Standaert. 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 [abstract]. Mov Disord. 2019; 34 (suppl 2). https://www.mdsabstracts.org/abstract/safety-and-tolerability-in-parkinsons-disease-patients-treated-with-a-continuous-subcutaneous-infusion-of-abbv-951-design-of-a-52-week-phase-3-study/. Accessed June 15, 2025.« Back to 2019 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/safety-and-tolerability-in-parkinsons-disease-patients-treated-with-a-continuous-subcutaneous-infusion-of-abbv-951-design-of-a-52-week-phase-3-study/