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
Sponsor:
AbbVie
Brief Summary:
The purpose of this study is to assess the safety and tolerability of ABBV-951 in subjects
with Parkinson’s disease (PD).
with Parkinson’s disease (PD).
Criteria
Inclusion Criteria:
– Subjects with diagnosis of idiopathic Parkinson’s Disease (PD) that is levodopa
-responsive
– Subjects 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 Criteria:
– Subject 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.
– Subject is considered by the investigator to be an unsuitable candidate to receive
ABBV-951 for any reason.
Locations
- Parkinson’s and Movement /ID# 216126, Fountain Valley, California, United States, 92708
