Back to resultsA 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
Primary Purpose
Parkinson's Disease (PD)
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ABBV-951
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease (PD) focused on measuring carbidopa, levodopa
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Banner Sun Health Res Inst /ID# 165840
- Loma Linda University /ID# 165592
- Univ CA, Irvine Med Ctr /ID# 165594
- Compass Research /ID# 167329
- Univ Kansas Med Ctr /ID# 166280
- University of Kentucky Chandler Medical Center /ID# 164407
- University of Louisville /ID# 164997
- Washington University-School of Medicine /ID# 164412
- NYU Langone Medical Center /ID# 164924
- University of Cincinnati /ID# 165142
- Cleveland Clinic Foundation /ID# 164413
- Neurology Consultants of Dallas /ID# 167116
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ABBV-951
Arm Description
ABBV-951 administered by continuous subcutaneous infusion (CSCI) for 4 weeks.
Outcomes
Primary Outcome Measures
Percentage of Participants with Infusion Site Reactions
Local tolerability (infusion site evaluation) was assessed using the Infusion Site Assessment 2-part rating scale.
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.
Percentage of Participants with Markedly Abnormal Vital Signs Values
Vital signs will be collected both supine and standing.
Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is an instrument designed to assess suicidal behavior and ideation.
Percentage of Participants with Potentially Clinically Significant Laboratory Values
Blood samples for serum chemistry tests will be collected following a minimum 8-hour fast.
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.
Secondary Outcome Measures
Plasma Concentrations of Levodopa
Blood samples for pharmacokinetic assessment will be collected twice at each visit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03374917
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 18, 2018 (Actual)
Primary Completion Date
March 4, 2019 (Actual)
Study Completion Date
March 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease (PD)
Keywords
carbidopa, levodopa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABBV-951
Arm Type
Experimental
Arm Description
ABBV-951 administered by continuous subcutaneous infusion (CSCI) for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
ABBV-951
Intervention Description
powder for solution
Primary Outcome Measure Information:
Title
Percentage of Participants with Infusion Site Reactions
Description
Local tolerability (infusion site evaluation) was assessed using the Infusion Site Assessment 2-part rating scale.
Time Frame
28 Days
Title
Number of Participants with Adverse Events
Description
Treatment emergent adverse events defined as any adverse event from the time of study drug administration until 30 days after discontinuation of study drug.
Time Frame
From first dose of study drug to 30 days after last dose of study drug (up to 2 months)
Title
Percentage of Participants with Markedly Abnormal Vital Signs Values
Description
Vital signs will be collected both supine and standing.
Time Frame
28 days
Title
Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
The C-SSRS is an instrument designed to assess suicidal behavior and ideation.
Time Frame
28 days
Title
Percentage of Participants with Potentially Clinically Significant Laboratory Values
Description
Blood samples for serum chemistry tests will be collected following a minimum 8-hour fast.
Time Frame
28 days
Title
Percentage of Participants with Potentially Clinically Significant Electrocardiogram (ECG) Results
Description
A 12-lead ECG will be performed after the participant has been supine for at least 5 minutes.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Plasma Concentrations of Levodopa
Description
Blood samples for pharmacokinetic assessment will be collected twice at each visit.
Time Frame
Days 1, 7, 14, 21, and 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Banner Sun Health Res Inst /ID# 165840
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Loma Linda University /ID# 165592
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Univ CA, Irvine Med Ctr /ID# 165594
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Compass Research /ID# 167329
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Univ Kansas Med Ctr /ID# 166280
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Kentucky Chandler Medical Center /ID# 164407
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Louisville /ID# 164997
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Washington University-School of Medicine /ID# 164412
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
NYU Langone Medical Center /ID# 164924
City
New York
State/Province
New York
ZIP/Postal Code
10016-6402
Country
United States
Facility Name
University of Cincinnati /ID# 165142
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0585
Country
United States
Facility Name
Cleveland Clinic Foundation /ID# 164413
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Neurology Consultants of Dallas /ID# 167116
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251-3831
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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