A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Infusions of ABBV-951 in Subjects With Parkinson's Disease
NCT ID: NCT03033498
Last Updated: 2024-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
29 participants
INTERVENTIONAL
2017-05-17
2019-06-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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 and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)
NCT03781167
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
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
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.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ABBV-951 Dose 1
Participants will receive dose 1 of ABBV-951.
ABBV-951
ABBV-951 administered by subcutaneous infusion.
ABBV-951 Dose 2
Participants will receive dose 2 of ABBV-951.
ABBV-951
ABBV-951 administered by subcutaneous infusion.
ABBV-951 Dose 3
Participants will receive dose 3 of ABBV-951.
ABBV-951
ABBV-951 administered by subcutaneous infusion.
ABBV-951 Dose 4
Participants will receive dose 4 of ABBV-951.
ABBV-951
ABBV-951 administered by subcutaneous infusion.
ABBV-951 Dose 5
Participants will receive dose 5 of ABBV-951.
ABBV-951
ABBV-951 administered by subcutaneous infusion.
ABBV-951 Dose 6
Participants will receive dose 6 of ABBV-951.
ABBV-951
ABBV-951 administered by subcutaneous infusion.
ABBV-951 Dose 7
Participants will receive dose 7 of ABBV-951.
ABBV-951
ABBV-951 administered by subcutaneous infusion.
ABBV-951 Dose 8
Participants will receive dose 8 of ABBV-951.
ABBV-951
ABBV-951 administered by subcutaneous infusion.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ABBV-951
ABBV-951 administered by subcutaneous infusion.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subject must be taking an optimized and stable regimen of oral medications for PD, which has remained stable and unchanged for at least 30 days before dosing in this study. This regimen must include oral carbidopa/levodopa (CD/LD) tablets (e.g., Sinemet).
* Females must have negative results for pregnancy tests at screening and prior to confinement.
* If male, subject must be surgically sterile or practicing an adequate method of birth control from initial study drug administration until 30 days after last dose of study drug.
* Body Mass Index (BMI) is 18.0 to 38.0, inclusive.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG).
Exclusion Criteria
* History of significant skin conditions or disorders (e.g., psoriasis, atopic dermatitis, etc.) or evidence of recent sunburn, acne, scar tissue, tattoo, open wound, branding, or colorations that in the Investigator's opinion would interfere with the infusion of the study drug or could interfere with study assessments.
* Use of any medication from the prohibited concomitant therapies.
* Subjects with glomerular filtration rate (GFR) less than 45 ml/min/1.73 m2 as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation.
* Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to initial study drug administration.
* Consideration by the investigator for any reason that the subject is an unsuitable candidate to receive ABBV-951.
45 Years
85 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.
Glendale Adventist Medical Ctr /ID# 166512
Glendale, California, United States
Bioclinica Research - Orlando /ID# 169687
Orlando, Florida, United States
Acpru /Id# 154976
Grayslake, Illinois, United States
University of Kentucky Chandler Medical Center /ID# 169086
Lexington, Kentucky, United States
Parexel Baltimore /ID# 169255
Baltimore, Maryland, United States
QUEST Research Institute /ID# 166035
Farmington Hills, Michigan, United States
Carolina Phase I, LLC /ID# 166034
Raleigh, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
clinical study report synopsis
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M15-738
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.