Study To Assess Adverse Events and Change in Disease Activity Of 24-hour Continuous Subcutaneous Infusion Of ABBV-951 In Adult Participants With Advanced Parkinson's Disease

Completed · Phase 3

Conditions studied: Parkinson's Disease (PD)

In brief

Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study will assess how safe and effective ABBV-951 is in adult participants with PD. Adverse events and change in disease activity is evaluated. ABBV-951 is an investigational (unapproved) drug containing Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP) given as an infusion under the skin for the treatment of Parkinson's Disease. Adult participants with advanced PD and who have completed M15-736 or M20-339 study will be enrolled. Approximately 130 participants will be enrolled in the study in approximately 60 sites in the United States and Australia. Participants will receive continuous subcutaneous infusion (CSCI) (under the skin) of ABBV-951 for 96 weeks during the Primary Treatment Period and during the optional Extended Treatment Period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical and remote telephone assessments, blood tests, checking for side effects, and completing questionnaires.

Key facts

Study ID

NCT04750226

Run by

AbbVie

People needed

118

Starts

2021-02-18

Expected to finish

2026-04-27

Last updated by the study team

2026-06-01

Who can join

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

You may qualify if…

• Completion of the parent study, Study M15-736 or Study M20-339.

You may not qualify if…

• Participant considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason.

Where it is running

• Usa Mitchell Cancer Institute /ID# 218467 — Mobile, Alabama, United States
• Xenoscience, Inc /ID# 222515 — Phoenix, Arizona, United States
• Muhammad Ali Parkinson Center /ID# 218609 — Phoenix, Arizona, United States
• Movement Disorders Center of Arizona /ID# 218471 — Scottsdale, Arizona, United States
• Neuro Pain Research Center /ID# 217720 — Fresno, California, United States
• Loma Linda University Medical /ID# 217724 — Loma Linda, California, United States
• University of California, Los Angeles /ID# 218460 — Los Angeles, California, United States
• SC3 Research Group - Pasadena /ID# 223018 — Pasadena, California, United States
• University of California, San /ID# 218595 — San Diego, California, United States
• Duplicate_Cedars-Sinai Medical Center-West Hollywood /ID# 218607 — West Hollywood, California, United States
• University of Colorado Hospital /ID# 218486 — Aurora, Colorado, United States
• Alpine Clinical Research Center /ID# 218461 — Boulder, Colorado, United States
• Denver Neurological Research, LLC /ID# 217811 — Denver, Colorado, United States
• CenExel Rocky Mountain Clinical Research, LLC /ID# 217731 — Englewood, Colorado, United States
• Georgetown University Hospital /ID# 218599 — Washington D.C., District of Columbia, United States
• Visionary Investigators Network - Miami /ID# 217726 — Miami, Florida, United States
• Renstar Medical Research /ID# 217837 — Ocala, Florida, United States
• Neurology Associates Ormond Beach /ID# 217800 — Ormond Beach, Florida, United States
• Parkinson's Disease Treatment Center of Southwest Florida /ID# 222679 — Port Charlotte, Florida, United States
• University of South Florida- Neuroscience Institute /ID# 218481 — Tampa, Florida, United States
• Premiere Research Institute - Palm Beach /ID# 218743 — West Palm Beach, Florida, United States
• Rush University Medical Center /ID# 217807 — Chicago, Illinois, United States
• University of Chicago Medical Center /ID# 218611 — Chicago, Illinois, United States
• St Elizabeth's Medical Center - Brighton /ID# 223082 — Brighton, Massachusetts, United States
• University of Alabama at Birmingham - Main /ID# 217814 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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