Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With 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. The purpose of this study is to continue testing whether ABBV-951 is safe, effective, and tolerable in participants with Parkinson's disease after completion of the parent study M15-741. ABBV-951 is an investigational (unapproved) drug containing levodopa phosphate/carbidopa phosphate (LDP/CDP) given as infusion under the skin for the treatment of Parkinson's Disease. Participants who have successfully completed M15-741 study will immediately enter this study's treatment period to continue receiving ABBV-951. Adult participants with advanced PD will be enrolled. Approximately 130 adult participants will be enrolled in the study at approximately 65 sites worldwide. Participants will receive continuous subcutaneous infusion (CSCI) of ABBV-951 for 24 hours daily 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 clinic visits and have remote assessments completed via phone calls during the course of the study. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.

Key facts

Study ID

NCT04379050

Run by

AbbVie

People needed

130

Starts

2020-06-08

Expected to finish

2026-04-17

Last updated by the study team

2026-05-13

Who can join

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

You may qualify if…

• Participants who have Parkinson's Disease and who have successfully completed the parent study M15-741.
• Participants willing and able to comply with procedures required in the protocol.

You may not qualify if…

• Participants, if judged by the investigator to be unsuitable candidates to continue to receive ABBV-951 for any reason.

Where it is running

• Banner Sun Health Research Institute /ID# 215579 — Sun City, Arizona, United States
• University of Colorado Hospital /ID# 215625 — Aurora, Colorado, United States
• Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 215412 — Boca Raton, Florida, United States
• Indiana Clinical Research Cent /ID# 216490 — Indianapolis, Indiana, United States
• Univ Kansas Med Ctr /ID# 215624 — Kansas City, Kansas, United States
• Washington University-School of Medicine /ID# 215472 — St Louis, Missouri, United States
• Dartmouth-Hitchcock Medical Center /ID# 216834 — Lebanon, New Hampshire, United States
• M3 Wake Research - Raleigh /ID# 215596 — Raleigh, North Carolina, United States
• Legacy Medical Group - Neurology /ID# 215536 — Portland, Oregon, United States
• Baylor College of Medicine /ID# 215401 — Houston, Texas, United States
• Central Texas Neurology Consul /ID# 217013 — Round Rock, Texas, United States
• Univ Texas HSC San Antonio /ID# 215400 — San Antonio, Texas, United States
• Booth Gardner Parkinson's Care Center /ID# 215535 — Kirkland, Washington, United States
• Inland Northwest Research /ID# 215533 — Spokane, Washington, United States
• Concord Repatriation General Hospital /ID# 215943 — Concord, New South Wales, Australia
• Westmead Hospital /ID# 215941 — Westmead, New South Wales, Australia
• Duplicate_Royal Adelaide Hospital /ID# 215940 — Adelaide, South Australia, Australia
• The Alfred Hospital /ID# 215942 — Melbourne, Victoria, Australia
• Perron Institute /ID# 215944 — Nedlands, Western Australia, Australia
• Universitair Ziekenhuis Leuven /ID# 215684 — Leuven, Vlaams-Brabant, Belgium
• Duplicate_Algemeen Ziekenhuis Sint-Jan Brugge /ID# 215686 — Bruges, West-Vlaanderen, Belgium
• Duplicate_Groupe Sante CHC - Clinique du MontLegia /ID# 215685 — Liège, Belgium
• University of Calgary /ID# 215369 — Calgary, Alberta, Canada
• Clinique Neuro Levis /ID# 215371 — Lévis, Quebec, Canada
• University of Alabama at Birmingham - Main /ID# 215597 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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