Clinical trial NCT03374917: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson's Disease (PD)
Keywords: carbidopa
levodopa
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-12-15
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Percentage of Participants with Infusion Site Reactions
timeFrame: 28 Days
measure: Number of Participants with Adverse Events
timeFrame: From first dose of study drug to 30 days after last dose of study drug (up to 2 months)
measure: Percentage of Participants with Markedly Abnormal Vital Signs Values
timeFrame: 28 days
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: 28 days
measure: Percentage of Participants with Potentially Clinically Significant Laboratory Values
timeFrame: 28 days
measure: Percentage of Participants with Potentially Clinically Significant Electrocardiogram (ECG) Results
timeFrame: 28 days
Secondary outcomes:
measure: Plasma Concentrations of Levodopa
timeFrame: Days 1, 7, 14, 21, and 28
Other outcomes:
Locations:
city: Sun City
country: United States
facility: Banner Sun Health Res Inst /ID# 165840
state: Arizona
city: Loma Linda
country: United States
facility: Loma Linda University /ID# 165592
state: California
city: Orange
country: United States
facility: Univ CA, Irvine Med Ctr /ID# 165594
state: California
city: Orlando
country: United States
facility: Compass Research /ID# 167329
state: Florida
city: Kansas City
country: United States
facility: Univ Kansas Med Ctr /ID# 166280
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center /ID# 164407
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville /ID# 164997
state: Kentucky
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 164412
state: Missouri
city: New York
country: United States
facility: NYU Langone Medical Center /ID# 164924
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati /ID# 165142
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation /ID# 164413
state: Ohio
city: Dallas
country: United States
facility: Neurology Consultants of Dallas /ID# 167116
state: Texas
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: