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
Status: | Completed |
---|---|
Conditions: | Parkinsons Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 30 - 85 |
Updated: | 3/15/2019 |
Start Date: | April 18, 2018 |
End Date: | March 4, 2019 |
An Open-Label Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 for up to 4 Weeks in an Outpatient Environment
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).
weeks of continuous infusion with ABBV-951 in adult subjects with Parkinson's Disease (PD).
Inclusion Criteria:
- 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 Criteria:
- 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.
We found this trial at
12
sites
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