Status:
COMPLETED
A Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 in an Outpatient Environment
Lead Sponsor:
AbbVie
Conditions:
Parkinson's Disease (PD)
Eligibility:
All Genders
30-85 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of 4 weeks of continuous infusion with ABBV-951 in adult subjects with Parkinson's Disease (PD).
Eligibility Criteria
Inclusion
- Subject with a diagnosis of definite idiopathic Parkinson's disease (PD) that is levodopa-responsive according to the United Kingdom Parkinson's Disease Society Brain Bank Criteria.
- Subject must be taking an optimized and stable regimen of oral medications for PD, which has remained stable and unchanged for at least 30 days before enrollment in this study.
- Subject is judged inadequately controlled on current therapy in the opinion of the Investigator and must experience a minimum of 2.5 hours of "off" time per day prior to Enrollment.
- Subjects with a MMSE score greater than or equal to 24 and considered by the Investigator to not have dementia.
Exclusion
- Subjects with clinically significant electrocardiogram (ECG) values.
- History of significant skin conditions or disorders that in the Investigator's opinion would interfere with the infusion of the study drug or could interfere with study assessments.
- Receipt of an investigational product within at least 6 weeks prior to study drug administration.
- Subjects with moderate to severe kidney disease.
- Consideration by the investigator for any reason that the subject is an unsuitable candidate to receive ABBV-951.
- Patient/caregiver that cannot demonstrate proper use of the devices (drug pump and wearable device) will not be allowed to participate.
Key Trial Info
Start Date :
April 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03374917
Start Date
April 18 2018
End Date
March 4 2019
Last Update
November 12 2024
Active Locations (12)
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1
Banner Sun Health Res Inst /ID# 165840
Sun City, Arizona, United States, 85351
2
Loma Linda University /ID# 165592
Loma Linda, California, United States, 92354
3
Univ CA, Irvine Med Ctr /ID# 165594
Orange, California, United States, 92868
4
Compass Research /ID# 167329
Orlando, Florida, United States, 32806