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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 12
- 主要终点
- Percentage of Participants with Infusion Site Reactions
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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-
- •Patient/caregiver that cannot demonstrate proper use of the devices (drug pump and wearable device) will not be allowed to participate.
研究组 & 干预措施
ABBV-951
ABBV-951 administered by continuous subcutaneous infusion (CSCI) for 4 weeks.
干预措施: ABBV-951 (Drug)
结局指标
主要结局
Percentage of Participants with Infusion Site Reactions
时间窗: 28 Days
Local tolerability (infusion site evaluation) was assessed using the Infusion Site Assessment 2-part rating scale.
Number of Participants with Adverse Events
时间窗: 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 Markedly Abnormal Vital Signs Values
时间窗: 28 days
Vital signs will be collected both supine and standing.
Columbia-Suicide Severity Rating Scale (C-SSRS)
时间窗: 28 days
The C-SSRS is an instrument designed to assess suicidal behavior and ideation.
Percentage of Participants with Potentially Clinically Significant Laboratory Values
时间窗: 28 days
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
时间窗: 28 days
A 12-lead ECG will be performed after the participant has been supine for at least 5 minutes.
次要结局
- Plasma Concentrations of Levodopa(Days 1, 7, 14, 21, and 28)