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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Parkinson's Disease (PD)

Intervention / Treatment
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* Drug: ABBV-951


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABBV-951<br>ABBV-951 administered by continuous subcutaneous infusion (CSCI) for 4 weeks. | Drug: ABBV-951<br>* powder for solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Concentrations of Levodopa | Blood samples for pharmacokinetic assessment will be collected twice at each visit. | Days 1, 7, 14, 21, and 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carbidopa, levodopa