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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
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. 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.
Official title: An Open-label Extension of Study M15-741 to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's Disease
Key Details
Gender
All
Age Range
30 Years - Any
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2020-06-08
Completion Date
2026-04
Last Updated
2025-08-05
Healthy Volunteers
No
Conditions
Interventions
ABBV-951
Solution for continuous subcutaneous infusion (CSCI).
Locations (51)
University of Alabama at Birmingham - Main /ID# 215597
Birmingham, Alabama, United States
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 Inc. /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
Bispebjerg and Frederiksberg Hospital /ID# 215391
Copenhagen NV, Capital Region, Denmark
Aarhus Universitetshospital - Skejby /ID# 215392
Aarhus, Central Jutland, Denmark
Odense University Hospital /ID# 215390
Odense, Region Syddanmark, Denmark
Universitaetsklinikum Ulm /ID# 215405
Ulm, Baden-Wurttemberg, Germany
curiositas ad sanum /ID# 215404
Haag i.OB, Bavaria, Germany
Kliniken Beelitz GmbH /ID# 215403
Beelitz-Heilstätten, Germany
IRCCS Centro Neurolesi Bonino Pulejo /ID# 215422
Messina, Italy
Azienda Ospedale-Universita Padova /ID# 215421
Padova, Italy
National Hospital Organization Asahikawa Medical Center /ID# 218762
Asahikawa-shi, Hokkaido, Japan
Duplicate_Osaka University Hospital /ID# 217415
Suita-shi, Osaka, Japan
National Center of Neurology and Psychiatry /ID# 218763
Kodaira-shi, Tokyo, Japan
St. Antonius Ziekenhuis /ID# 215396
Nieuwegein, Utrecht, Netherlands
Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 218869
Saint Petersburg, Sankt-Peterburg, Russia
City Clinical Hospital #40 /ID# 218870
Sestroretsk, Sankt-Peterburg, Russia
Complejo Hospitalario Universitario A Coruña /ID# 215426
A Coruña, A Coruna, Spain
Hospital General Universitario de Elche /ID# 215425
Elche, Alicante, Spain
Hospital Universitari de Bellvitge /ID# 215427
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Santa Creu i Sant Pau /ID# 215429
Barcelona, Spain
Hospital Universitario Virgen de las Nieves /ID# 215431
Granada, Spain
Hospital Universitario Virgen del Rocio /ID# 215428
Seville, Spain
Skane University Hospital Lund /ID# 215385
Lund, Skåne County, Sweden
Karolinska Universitetssjukhuset - Huddinge /ID# 215386
Huddinge, Stockholm County, Sweden
Sahlgrenska Universitetssjukhuset /ID# 215387
Gothenburg, Västra Götaland County, Sweden
Derriford Hospital and the Royal Eye Infirmary /ID# 217390
Plymouth, Devon, United Kingdom
NHS Tayside /ID# 217389
Dundee, Scotland, United Kingdom
King's College Hospital NHS Foundation Trust /ID# 217388
London, United Kingdom