A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)
NCT ID: NCT03781167
Last Updated: 2023-10-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
244 participants
INTERVENTIONAL
2019-04-29
2022-08-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 in an Outpatient Environment
NCT03374917
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Infusions of ABBV-951 in Subjects With Parkinson's Disease
NCT03033498
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
NCT04379050
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
NCT04750226
Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations In Adult Participants With Advanced Parkinson's Disease
NCT04380142
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ABBV-951 Low Dose Subgroup
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
ABBV-951
Solution for continuous subcutaneous infusion (CSCI)
ABBV-951 High Dose Subgroup
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
ABBV-951
Solution for continuous subcutaneous infusion (CSCI)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ABBV-951
Solution for continuous subcutaneous infusion (CSCI)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* Participant is considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason
30 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AbbVie
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham - Main /ID# 207996
Birmingham, Alabama, United States
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
Westmead Hospital /ID# 207633
Westmead, New South Wales, Australia
Royal Adelaide Hospital /ID# 207634
Adelaide, South Australia, Australia
Alfred Health /ID# 207632
Melbourne, Victoria, Australia
Perron Institute /ID# 207627
Nedlands, Western Australia, Australia
Universitair Ziekenhuis Leuven /ID# 209058
Leuven, Vlaams-Brabant, Belgium
AZ Sint-Jan Brugge /ID# 208178
Bruges, , Belgium
Groupe Sante CHC - Clinique du MontLegia /ID# 208177
Liège, , Belgium
University of Calgary - Movement Disorders Clinic /ID# 207342
Calgary, Alberta, Canada
Centre de Recherche St-Louis /ID# 207344
Québec, Quebec, Canada
Bispebjerg and Frederiksberg Hospital /ID# 207669
Copenhagen NV, Capital Region, Denmark
Aarhus University Hospital /ID# 207668
Aarhus N, Central Jutland, Denmark
Odense University Hospital /ID# 207871
Odense C, Region Syddanmark, Denmark
Universitaetsklinikum Ulm /ID# 208602
Ulm, Baden-Wurttemberg, Germany
Kliniken Beelitz GmbH /ID# 208600
Beelitz-Heilstätten, , Germany
InnKlinikum Haag /ID# 208601
Haag, , Germany
IRCCS Centro Neurolesi Bonino Pulejo /ID# 207975
Messina, , Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 207955
Milan, , Italy
Azienda Ospedaliera di Padova /ID# 208077
Padua, , Italy
National Hospital Organization Asahikawa Medical Center /ID# 210914
Asahikawa-shi, Hokkaido, Japan
National Hospital Organization Utano National Hospital /ID# 210912
Kyoto, Kyoto, Japan
Osaka University Hospital /ID# 210913
Suita-shi, Osaka, Japan
Juntendo University Hospital /ID# 210915
Bunkyo-ku, Tokyo, Japan
National Center of Neurology and Psychiatry /ID# 210911
Kodaira-shi, Tokyo, Japan
Erasmus Medisch Centrum /ID# 208168
Rotterdam, South Holland, Netherlands
St. Antonius Ziekenhuis /ID# 208529
Nieuwegein, , Netherlands
Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 216303
Saint Petersburg, Sankt-Peterburg, Russia
City Clinical Hospital #40 /ID# 216301
Sestroretsk, Sankt-Peterburg, Russia
Hospital General Universitario de Elche /ID# 209777
Elche, Alicante, Spain
Hospital Universitario de Bellvitge /ID# 209539
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario A Coruna - CHUAC /ID# 212147
A Coruña, , Spain
Hospital Santa Creu i Sant Pau /ID# 208240
Barcelona, , Spain
Hospital Universitario Virgen de las Nieves /ID# 208242
Granada, , Spain
Hospital Universitario Ramon y Cajal /ID# 208241
Madrid, , Spain
Hospital Universitario Virgen del Rocio /ID# 208239
Seville, , Spain
Skane University Hospital Lund /ID# 207811
Lund, Skåne County, Sweden
Centrum for neurologi /ID# 207716
Stockholm, Stockholm County, Sweden
Sahlgrenska University Hospital /ID# 207718
Gothenburg, Västra Götaland County, Sweden
NHS Tayside /ID# 209242
Dundee, Scotland, United Kingdom
King's College Hospital NHS Foundation Trust /ID# 208413
London, , United Kingdom
University Hospital Plymouth NHS Trust /ID# 208447
Plymouth, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Pahwa R, Aldred J, Soileau MJ, Standaert DG, Fung VSC, Kimber T, Malaty IA, Santos-Garcia D, Carroll C, Henriksen T, Parab A, Yan CH, Facheris MF, Spiegel A, Harmer L, Zamudio J, Chaudhuri KR. Improvement in Motor Consistency and Stability with Foslevodopa/Foscarbidopa in Advanced Parkinson's Disease: Post Hoc Analysis of Two Phase 3 Clinical Trials. Neurol Ther. 2025 Oct 4. doi: 10.1007/s40120-025-00827-6. Online ahead of print.
Chaudhuri KR, Facheris MF, Bergmans B, Bergquist F, Criswell SR, Jia J, Kukreja P, Mukai Y, Spiegel AM, Gupta R, Bergmann L, Pahwa R. Improved Sleep Correlates with Improved Quality of Life and Motor Symptoms with Foslevodopa/Foscarbidopa. Mov Disord Clin Pract. 2024 Jul;11(7):861-866. doi: 10.1002/mdc3.14018. Epub 2024 Mar 11.
Aldred J, Freire-Alvarez E, Amelin AV, Antonini A, Bergmans B, Bergquist F, Bouchard M, Budur K, Carroll C, Chaudhuri KR, Criswell SR, Danielsen EH, Gandor F, Jia J, Kimber TE, Mochizuki H, Robieson WZ, Spiegel AM, Standaert DG, Talapala S, Facheris MF, Fung VSC. Continuous Subcutaneous Foslevodopa/Foscarbidopa in Parkinson's Disease: Safety and Efficacy Results From a 12-Month, Single-Arm, Open-Label, Phase 3 Study. Neurol Ther. 2023 Dec;12(6):1937-1958. doi: 10.1007/s40120-023-00533-1. Epub 2023 Aug 26.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018-002144-85
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M15-741
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.