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
NCT ID: NCT03374917
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
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2018-04-18
2019-03-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ABBV-951
ABBV-951 administered by continuous subcutaneous infusion (CSCI) for 4 weeks.
ABBV-951
powder for solution
Interventions
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ABBV-951
powder for solution
Eligibility Criteria
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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 enrollment in this study.
* Subject is judged inadequately controlled on current therapy in the opinion of the Investigator and must experience a minimum of 2.5 hours of "off" time per day prior to Enrollment.
* Subjects with a MMSE score greater than or equal to 24 and considered by the Investigator to not have dementia.
Exclusion Criteria
* History of significant skin conditions or disorders that in the Investigator's opinion would interfere with the infusion of the study drug or could interfere with study assessments.
* Receipt of an investigational product within at least 6 weeks prior to study drug administration.
* Subjects with moderate to severe kidney disease.
* Consideration by the investigator for any reason that the subject is an unsuitable candidate to receive ABBV-951.
* Patient/caregiver that cannot demonstrate proper use of the devices (drug pump and wearable device) will not be allowed to participate.
30 Years
85 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Banner Sun Health Res Inst /ID# 165840
Sun City, Arizona, United States
Loma Linda University /ID# 165592
Loma Linda, California, United States
Univ CA, Irvine Med Ctr /ID# 165594
Orange, California, United States
Compass Research /ID# 167329
Orlando, Florida, United States
Univ Kansas Med Ctr /ID# 166280
Kansas City, Kansas, United States
University of Kentucky Chandler Medical Center /ID# 164407
Lexington, Kentucky, United States
University of Louisville /ID# 164997
Louisville, Kentucky, United States
Washington University-School of Medicine /ID# 164412
St Louis, Missouri, United States
NYU Langone Medical Center /ID# 164924
New York, New York, United States
University of Cincinnati /ID# 165142
Cincinnati, Ohio, United States
Cleveland Clinic Foundation /ID# 164413
Cleveland, Ohio, United States
Neurology Consultants of Dallas /ID# 167116
Dallas, Texas, United States
Countries
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Related Links
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clinical study report synopsis
Other Identifiers
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M15-739
Identifier Type: -
Identifier Source: org_study_id
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