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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
powder for solution
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
Percentage of Participants with Infusion Site Reactions
Local tolerability (infusion site evaluation) was assessed using the Infusion Site Assessment 2-part rating scale.
Time frame: 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.
Time frame: 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.
Time frame: 28 days
Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is an instrument designed to assess suicidal behavior and ideation.
Time frame: 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.
Time frame: 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.
Time frame: 28 days
Plasma Concentrations of Levodopa
Blood samples for pharmacokinetic assessment will be collected twice at each visit.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 2 more locations
Time frame: Days 1, 7, 14, 21, and 28