A Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 in an Outpatient Environment

Completed · Phase 1

Conditions studied: Parkinson's Disease (PD)

In brief

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of 4 weeks of continuous infusion with ABBV-951 in adult subjects with Parkinson's Disease (PD).

Key facts

Study ID

NCT03374917

Run by

AbbVie

People needed

20

Starts

2018-04-18

Expected to finish

2019-03-04

Last updated by the study team

2024-11-12

Who can join

Age: 30 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject with a diagnosis of definite idiopathic Parkinson's disease (PD) that is levodopa-responsive according to the United Kingdom Parkinson's Disease Society Brain Bank Criteria.
• Subject must be taking an optimized and stable regimen of oral medications for PD, which has remained stable and unchanged for at least 30 days before enrollment in this study.
• Subject is judged inadequately controlled on current therapy in the opinion of the Investigator and must experience a minimum of 2.5 hours of "off" time per day prior to Enrollment.
• Subjects with a MMSE score greater than or equal to 24 and considered by the Investigator to not have dementia.

You may not qualify if…

• Subjects with clinically significant electrocardiogram (ECG) values.
• History of significant skin conditions or disorders that in the Investigator's opinion would interfere with the infusion of the study drug or could interfere with study assessments.
• Receipt of an investigational product within at least 6 weeks prior to study drug administration.
• Subjects with moderate to severe kidney disease.
• Consideration by the investigator for any reason that the subject is an unsuitable candidate to receive ABBV-951.
• Patient/caregiver that cannot demonstrate proper use of the devices (drug pump and wearable device) will not be allowed to participate.

Where it is running

• Banner Sun Health Res Inst /ID# 165840 — Sun City, Arizona, United States
• Loma Linda University /ID# 165592 — Loma Linda, California, United States
• Univ CA, Irvine Med Ctr /ID# 165594 — Orange, California, United States
• Compass Research /ID# 167329 — Orlando, Florida, United States
• Univ Kansas Med Ctr /ID# 166280 — Kansas City, Kansas, United States
• University of Kentucky Chandler Medical Center /ID# 164407 — Lexington, Kentucky, United States
• University of Louisville /ID# 164997 — Louisville, Kentucky, United States
• Washington University-School of Medicine /ID# 164412 — St Louis, Missouri, United States
• NYU Langone Medical Center /ID# 164924 — New York, New York, United States
• University of Cincinnati /ID# 165142 — Cincinnati, Ohio, United States
• Cleveland Clinic Foundation /ID# 164413 — Cleveland, Ohio, United States
• Neurology Consultants of Dallas /ID# 167116 — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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