NCT04750226

Study To Assess Adverse Events and Change in Disease Activity Of 24-hour Continuous Subcutaneous Infusion Of ABBV-951 In Adult Participants With Advanced Parkinson's Disease

An Open-Label Extension of Studies M15-736 and M20-339 to Evaluate the Safety and Tolerability of 24-Hour Daily Exposure of ABBV-951 in Subjects With Advanced Parkinson's Disease

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study will assess how safe and effective ABBV-951 is in adult participants with PD. Adverse events and change in disease activity is evaluated. ABBV-951 is an investigational (unapproved) drug containing Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP) given as an infusion under the skin for the treatment of Parkinson's Disease. Adult participants with advanced PD and who have completed M15-736 or M20-339 study will be enrolled. Approximately 130 participants will be enrolled in the study in approximately 60 sites in the United States and Australia. Participants will receive continuous subcutaneous infusion (CSCI) (under the skin) of ABBV-951 for 96 weeks during the Primary Treatment Period and during the optional Extended Treatment Period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical and remote telephone assessments, blood tests, checking for side effects, and completing questionnaires.

Conditions

• Parkinson's Disease (PD)

Interventions

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

Timeline

• Start date: 2021-02-18
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2021-02-11
• Last updated: 2025-08-12

Locations

52 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study