Status:
COMPLETED
A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)
Lead Sponsor:
AbbVie
Conditions:
Parkinson's Disease (PD)
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief 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 a...
Eligibility Criteria
Inclusion
- Participants with diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa-responsive
- Participants must be judged by the investigator to be inadequately controlled by current therapy, have recognizable/identifiable "Off" and "On" states (motor fluctuations), and have a minimum of 2.5 hours of "Off" time per day
Exclusion
- Participant is cognitively impaired and is not able to safely and effectively manage the drug delivery system and the diaries and is not able to adhere to the study
- Participant is considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason
Key Trial Info
Start Date :
April 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2022
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT03781167
Start Date
April 29 2019
End Date
August 17 2022
Last Update
October 23 2023
Active Locations (65)
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1
University of Alabama at Birmingham - Main /ID# 207996
Birmingham, Alabama, United States, 35233
2
Banner Sun Health Res Inst /ID# 208811
Sun City, Arizona, United States, 85351
3
The Parkinson's & Movement Disorder Institute - Fountain Valley /ID# 216126
Fountain Valley, California, United States, 92708
4
University of Colorado Hospital /ID# 207968
Aurora, Colorado, United States, 80045