A 52-Week, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson’s Disease

Status: 
Recruiting
Clinicaltrials.gov identifier: 
NCT03781167
Sponsor: 
AbbVie
Enrollment: 
130
Study Design: 
This is a phase 3, 52-week, open-label, a single-arm interventional study evaluating the safety and tolerability of continuous s.c. infusion of the active drug ABBV-951. The study is including participants 30 years or older with levodopa responsive idiopathic PD inadequately controlled by their current therapy and having recognizable motor fluctuations, with a minimum of daily 2.5 hrs of OFF time. Standard exclusionary criteria are applied including cognitive impairment that will prevent the participant to safely and effectively adhere to the study requirements. The study is being conducted across multiple international centers. The study includes a screening period, a dose optimization period of 4 weeks followed by 48 weeks of the maintenance period. The study requires a daily 24 hr infusion via a s.c. pump.
Rationale: 
The primary objective of the study overall focuses on the safety profile of the drug. It monitors the following from the day of the infusion through 30 days after the last infusion device is removed. 1. Treatment emergent AE with a focus on AE of special interest defined as any AE of polyneuropathy or weight loss. 2. Effect on blood and urine parameters from baseline to the end of the study. 3. Effect on blood pressure, pulse rate and abnormal electrocardiogram up to 56 weeks. The secondary outcomes focus on the clinical outcome looking at the change from baseline to the end of the study, which is up to 56 weeks. 1. Average normalized daily OFF time and ON time. 2. Parkinson’s symptoms as assessed by the MDS-UPDRS parts I-IV. 3. Quality of life using the PDQ-39 and EQ-5D-5L scores. 4. Sleep symptoms using the Parkinson’s Disease Sleep Scale-2.
Comments: 
Since these are initial studies, their focus is on the safety and tolerability profile. It will be important to demonstrate equal, if not superior, long-term PK profile of the prodrug with similar clinical efficacy as compared to LCIG. The newer drug, if successful, may provide a less invasive alternative to appropriate candidates in comparison to LCIG via PEG-J tube and potentially bypass gastric related complications. The trial is still ongoing and design for the study was presented during the 2019 Movement Disorder Society – International Congress.