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

Parkinson's Disease (PD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03374917
• Other study ID #: M15-739
• Status: Completed
• Phase: Phase 1
• Start date: April 18, 2018
• Est. completion date: March 4, 2019

Study information

• Verified date: March 2019
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 4, 2019
• Est. primary completion date: March 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease (PD)

Intervention

Drug:
• ABBV-951
powder for solution

Locations

Country	Name	City	State
United States	University of Cincinnati /ID# 165142	Cincinnati	Ohio
United States	Cleveland Clinic Foundation /ID# 164413	Cleveland	Ohio
United States	Neurology Consultants of Dallas /ID# 167116	Dallas	Texas
United States	Univ Kansas Med Ctr /ID# 166280	Kansas City	Kansas
United States	University of Kentucky Chandler Medical Center /ID# 164407	Lexington	Kentucky
United States	Loma Linda University /ID# 165592	Loma Linda	California
United States	University of Louisville /ID# 164997	Louisville	Kentucky
United States	NYU Langone Medical Center /ID# 164924	New York	New York
United States	Univ CA, Irvine Med Ctr /ID# 165594	Orange	California
United States	Compass Research /ID# 167329	Orlando	Florida
United States	Washington University-School of Medicine /ID# 164412	Saint Louis	Missouri
United States	Banner Sun Health Res Inst /ID# 165840	Sun City	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Infusion Site Reactions	Local tolerability (infusion site evaluation) was assessed using the Infusion Site Assessment 2-part rating scale.	28 Days
Primary	Number of Participants with Adverse Events	Treatment emergent adverse events defined as any adverse event from the time of study drug administration until 30 days after discontinuation of study drug.	From first dose of study drug to 30 days after last dose of study drug (up to 2 months)
Primary	Percentage of Participants with Markedly Abnormal Vital Signs Values	Vital signs will be collected both supine and standing.	28 days
Primary	Columbia-Suicide Severity Rating Scale (C-SSRS)	The C-SSRS is an instrument designed to assess suicidal behavior and ideation.	28 days
Primary	Percentage of Participants with Potentially Clinically Significant Laboratory Values	Blood samples for serum chemistry tests will be collected following a minimum 8-hour fast.	28 days
Primary	Percentage of Participants with Potentially Clinically Significant Electrocardiogram (ECG) Results	A 12-lead ECG will be performed after the participant has been supine for at least 5 minutes.	28 days
Secondary	Plasma Concentrations of Levodopa	Blood samples for pharmacokinetic assessment will be collected twice at each visit.	Days 1, 7, 14, 21, and 28