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
An Open-Label Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 for up to 4 Weeks in an Outpatient Environment
1 other identifier
interventional
20
1 country
12
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of 4 weeks of continuous infusion with ABBV-951 in adult subjects with Parkinson's Disease (PD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2018
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2017
CompletedFirst Posted
Study publicly available on registry
December 15, 2017
CompletedStudy Start
First participant enrolled
April 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 4, 2019
CompletedNovember 12, 2024
November 1, 2024
11 months
December 8, 2017
November 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Percentage of Participants with Infusion Site Reactions
Local tolerability (infusion site evaluation) was assessed using the Infusion Site Assessment 2-part rating scale.
28 Days
Number of Participants with Adverse Events
Treatment emergent adverse events defined as any adverse event from the time of study drug administration until 30 days after discontinuation of study drug.
From first dose of study drug to 30 days after last dose of study drug (up to 2 months)
Percentage of Participants with Markedly Abnormal Vital Signs Values
Vital signs will be collected both supine and standing.
28 days
Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is an instrument designed to assess suicidal behavior and ideation.
28 days
Percentage of Participants with Potentially Clinically Significant Laboratory Values
Blood samples for serum chemistry tests will be collected following a minimum 8-hour fast.
28 days
Percentage of Participants with Potentially Clinically Significant Electrocardiogram (ECG) Results
A 12-lead ECG will be performed after the participant has been supine for at least 5 minutes.
28 days
Secondary Outcomes (1)
Plasma Concentrations of Levodopa
Days 1, 7, 14, 21, and 28
Study Arms (1)
ABBV-951
EXPERIMENTALABBV-951 administered by continuous subcutaneous infusion (CSCI) for 4 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Subject with a diagnosis of definite idiopathic Parkinson's disease (PD) that is levodopa-responsive according to the United Kingdom Parkinson's Disease Society Brain Bank 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.
You may not qualify if:
- Subjects with clinically significant electrocardiogram (ECG) values.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (12)
Banner Sun Health Res Inst /ID# 165840
Sun City, Arizona, 85351, United States
Loma Linda University /ID# 165592
Loma Linda, California, 92354, United States
Univ CA, Irvine Med Ctr /ID# 165594
Orange, California, 92868, United States
Compass Research /ID# 167329
Orlando, Florida, 32806, United States
Univ Kansas Med Ctr /ID# 166280
Kansas City, Kansas, 66160, United States
University of Kentucky Chandler Medical Center /ID# 164407
Lexington, Kentucky, 40536, United States
University of Louisville /ID# 164997
Louisville, Kentucky, 40202, United States
Washington University-School of Medicine /ID# 164412
St Louis, Missouri, 63110, United States
NYU Langone Medical Center /ID# 164924
New York, New York, 10016-6402, United States
University of Cincinnati /ID# 165142
Cincinnati, Ohio, 45267-0585, United States
Cleveland Clinic Foundation /ID# 164413
Cleveland, Ohio, 44195, United States
Neurology Consultants of Dallas /ID# 167116
Dallas, Texas, 75251-3831, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2017
First Posted
December 15, 2017
Study Start
April 18, 2018
Primary Completion
March 4, 2019
Study Completion
March 4, 2019
Last Updated
November 12, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share