NCT03781167

A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)

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: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 244 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to assess the safety and tolerability of ABBV-951 (Foslevodopa/Foscarbidopa) in participants with Parkinson's disease (PD). This was a single-arm study with preplanned analyses conducted by dose subgroup (Low Dose or High Dose) based on the modal total daily dose (most frequent dose) over the treatment period.

Conditions

• Parkinson's Disease (PD)

Interventions

Type	Name	Description
DRUG	ABBV-951	Solution for continuous subcutaneous infusion (CSCI)

Timeline

• Start date: 2019-04-29
• Primary completion: 2022-08-17
• Completion: 2022-08-17
• First posted: 2018-12-19
• Last updated: 2023-10-23
• Results posted: 2023-10-23

Locations

65 sites across 13 countries: United States, Australia, Belgium, Canada, Denmark, Germany, Italy, Japan, Netherlands, Russia, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study