Status:
COMPLETED
Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations In Adult Participants With Advanced Parkinson's Disease
Lead Sponsor:
AbbVie
Conditions:
Parkinson's Disease (PD)
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief 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 tremor...
Eligibility Criteria
Inclusion
- Diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa-responsive.
- Participant must be taking a minimum of 400 milligrams/day (mg/day) of Levodopa (LD) equivalents and be judged by the investigator to have motor symptoms inadequately controlled by current therapy, have a recognizable/identifiable "Off" and "On" states (motor fluctuations), and have an average "Off" time of at least 2.5 hours/day over 3 consecutive PD Diary days with a minimum of 2 hours each day.
- Participant or caregiver, if applicable, demonstrates the understanding and correct use of the delivery system, including the insertion of the cannula into the participant's abdomen, as assessed by the investigator or designee during the Screening period.
Exclusion
- Clinically significant, unstable medical conditions or any other reason that the investigator determines would interfere with the participant's participation in this study or would make the participant an unsuitable candidate to receive study drug.
- History of allergic reaction or significant sensitivity to LD or constituents of the study drug (and its excipients) and/or other products in the same class.
- Participant has not received deep brain stimulation, CD/LD enteral suspension, or any other PD medication as continuous daily infusion, whether commercially available or investigational. Previous exposure to ABBV-951 is not allowed.
Key Trial Info
Start Date :
October 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2021
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT04380142
Start Date
October 19 2020
End Date
September 29 2021
Last Update
November 18 2022
Active Locations (76)
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1
University of Alabama at Birmingham - Main /ID# 216595
Birmingham, Alabama, United States, 35233
2
University of South Alabama /ID# 216757
Mobile, Alabama, United States, 36604-3302
3
Xenoscience, Inc /ID# 217110
Phoenix, Arizona, United States, 85004
4
Barrow Neurological Institute /ID# 216566
Phoenix, Arizona, United States, 85013-4407