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

AbbVie

Status and phase

Completed

Phase 1

Conditions

Parkinson's Disease (PD)

Treatments

Drug: ABBV-951

Study type

Interventional

Funder types

Industry

Identifiers

NCT03374917

M15-739

Details and patient eligibility

About

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).

Enrollment

20 patients

Sex

All

Ages

30 to 85 years old

Volunteers

No Healthy Volunteers

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.