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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
Sponsor: AbbVie
Summary
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.
Official title: An Open-Label Extension of Studies M15-736 and M20-339 to Evaluate the Safety and Tolerability of 24-Hour Daily Exposure of ABBV-951 in Subjects With Advanced Parkinson's Disease
Key Details
Gender
All
Age Range
30 Years - Any
Study Type
INTERVENTIONAL
Enrollment
118
Start Date
2021-02-18
Completion Date
2026-04
Last Updated
2025-08-12
Healthy Volunteers
No
Conditions
Interventions
ABBV-951
Solution for continuous subcutaneous infusion (CSCI).
Locations (52)
University of Alabama at Birmingham - Main /ID# 217814
Birmingham, Alabama, United States
University of South Alabama /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 Medical 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 /ID# 218611
Chicago, Illinois, United States
St Elizabeth's Medical Center - Brighton /ID# 223082
Brighton, Massachusetts, United States
St. Luke's Hosp. of Kansas City /ID# 218604
Kansas City, Missouri, United States
Washington University-School of Medicine /ID# 217723
St Louis, Missouri, United States
Global Neurosciences Institute /ID# 218472
Lawrenceville, New Jersey, United States
Northwell Health /ID# 218600
Lake Success, New York, United States
M3 Wake Research Inc. /ID# 218482
Raleigh, North Carolina, United States
The Orthopedic Foundation /ID# 218608
New Albany, Ohio, United States
The Movement Disorder Clinic of Oklahoma /ID# 218580
Tulsa, Oklahoma, United States
Legacy Medical Group - Neurology /ID# 217804
Portland, Oregon, United States
University of Pennsylvania /ID# 218605
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital /ID# 218594
Philadelphia, Pennsylvania, United States
Prisma Health-Upstate /ID# 217803
Greenville, South Carolina, United States
Coastal Neurology /ID# 222893
Port Royal, South Carolina, United States
KCA Neurology - Franklin /ID# 222811
Franklin, Tennessee, United States
Vanderbilt University Medical Center /ID# 217722
Nashville, Tennessee, United States
St. David's Healthcare Partnership, L.P., LLP /ID# 248148
Austin, Texas, United States
Houston Pulmonary Sleep and Allergy Associates /ID# 218473
Cypress, Texas, United States
Texas Movement Disorder Specialists /ID# 218610
Georgetown, Texas, United States
Baylor College of Medicine /ID# 217728
Houston, Texas, United States
University of Utah Health Care /ID# 218597
Salt Lake City, Utah, United States
Neurological Associates - Forest Ave /ID# 218458
Richmond, Virginia, United States
Inland Northwest Research /ID# 222520
Spokane, Washington, United States
Duplicate_Medical College of Wisconsin /ID# 217721
Milwaukee, Wisconsin, United States
Liverpool Hospital /ID# 221693
Liverpool, New South Wales, Australia
Westmead Hospital /ID# 218418
Westmead, New South Wales, Australia
Gold coast University Hospital /ID# 221694
Southport, Queensland, Australia
Royal Adelaide Hospital /ID# 218417
Adelaide, South Australia, Australia
The Royal Melbourne Hospital /ID# 218419
Parkville, Victoria, Australia