Parkinson's Disease (PD)
Conditions
Keywords
carbidopa, levodopa
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).
Interventions
DRUGABBV-951
powder for solution
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with Markedly Abnormal Vital Signs Values | 28 days | Vital signs will be collected both supine and standing. |
| Percentage of Participants with Infusion Site Reactions | 28 Days | Local tolerability (infusion site evaluation) was assessed using the Infusion Site Assessment 2-part rating scale. |
| Number of Participants with Adverse Events | From first dose of study drug to 30 days after last dose of study drug (up to 2 months) | 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 Potentially Clinically Significant Electrocardiogram (ECG) Results | 28 days | A 12-lead ECG will be performed after the participant has been supine for at least 5 minutes. |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | 28 days | The C-SSRS is an instrument designed to assess suicidal behavior and ideation. |
| Percentage of Participants with Potentially Clinically Significant Laboratory Values | 28 days | Blood samples for serum chemistry tests will be collected following a minimum 8-hour fast. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentrations of Levodopa | Days 1, 7, 14, 21, and 28 | Blood samples for pharmacokinetic assessment will be collected twice at each visit. |
Countries
United States
Outcome results
None listed