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

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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).


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
Loma Linda, California 92354
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Cincinnati, Ohio 45267
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Cincinnati, OH
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Cleveland, OH
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Dallas, TX
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Kansas City, Kansas 66160
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Kansas City, KS
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Lexington, KY
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Louisville, Kentucky 40202
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Louisville, KY
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New York, New York 10016
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New York, NY
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Orange, California 92868
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Orange, CA
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Orlando, Florida 32806
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Orlando, FL
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Saint Louis, MO
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Sun City, Arizona 85351
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Sun City, AZ
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