A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)

Completed · Phase 3

Conditions studied: Parkinson's Disease (PD)

In brief

The purpose of this study was to assess the safety and tolerability of ABBV-951 (Foslevodopa/Foscarbidopa) in participants with Parkinson's disease (PD). This was a single-arm study with preplanned analyses conducted by dose subgroup (Low Dose or High Dose) based on the modal total daily dose (most frequent dose) over the treatment period.

Key facts

Study ID

NCT03781167

Run by

AbbVie

People needed

244

Starts

2019-04-29

Expected to finish

2022-08-17

Last updated by the study team

2023-10-23

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa-responsive
• Participants must be judged by the investigator to be inadequately controlled by current therapy, have recognizable/identifiable "Off" and "On" states (motor fluctuations), and have a minimum of 2.5 hours of "Off" time per day

You may not qualify if…

• Participant is cognitively impaired and is not able to safely and effectively manage the drug delivery system and the diaries and is not able to adhere to the study
• Participant is considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason

Where it is running

• Banner Sun Health Res Inst /ID# 208811 — Sun City, Arizona, United States
• The Parkinson's & Movement Disorder Institute - Fountain Valley /ID# 216126 — Fountain Valley, California, United States
• University of Colorado Hospital /ID# 207968 — Aurora, Colorado, United States
• Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 207677 — Boca Raton, Florida, United States
• Northwestern University Feinberg School of Medicine /ID# 208812 — Chicago, Illinois, United States
• Indiana Clinical Research Cent /ID# 207952 — Indianapolis, Indiana, United States
• Univ Kansas Med Ctr /ID# 208963 — Kansas City, Kansas, United States
• University of Kentucky Chandler Medical Center /ID# 207603 — Lexington, Kentucky, United States
• Massachusetts General Hospital /ID# 207993 — Boston, Massachusetts, United States
• Health Partners /ID# 207950 — Saint Paul, Minnesota, United States
• University of Missouri /ID# 209043 — Columbia, Missouri, United States
• Washington University-School of Medicine /ID# 207525 — St Louis, Missouri, United States
• Dartmouth-Hitchcock Medical Center /ID# 207972 — Lebanon, New Hampshire, United States
• Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 209784 — Raleigh, North Carolina, United States
• Legacy Medical Group - Neurology /ID# 208031 — Portland, Oregon, United States
• Prisma Health Cancer Institute-Faris Road /ID# 207650 — Greenville, South Carolina, United States
• Neurology Consultants of Dallas - LBJ Fwy /ID# 207619 — Dallas, Texas, United States
• Baylor College of Medicine /ID# 207620 — Houston, Texas, United States
• Central Texas Neurology Consul /ID# 216918 — Round Rock, Texas, United States
• Univ Texas HSC San Antonio /ID# 208958 — San Antonio, Texas, United States
• Booth Gardner Parkinson's Care Center /ID# 208026 — Kirkland, Washington, United States
• Inland Northwest Research /ID# 208122 — Spokane, Washington, United States
• Medical College of Wisconsin /ID# 207999 — Milwaukee, Wisconsin, United States
• Concord Repatriation General Hospital /ID# 207628 — Concord, New South Wales, Australia
• University of Alabama at Birmingham - Main /ID# 207996 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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