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

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).

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease (PD)
• Intervention / Treatment: Drug: ABBV-951

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Sun City, Arizona, United States, 85351
      • Banner Sun Health Res Inst /ID# 165840
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University /ID# 165592
    • Orange, California, United States, 92868
      • Univ CA, Irvine Med Ctr /ID# 165594
  • Florida
    • Orlando, Florida, United States, 32806
      • Compass Research /ID# 167329
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Univ Kansas Med Ctr /ID# 166280
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Chandler Medical Center /ID# 164407
    • Louisville, Kentucky, United States, 40202
      • University of Louisville /ID# 164997
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University-School of Medicine /ID# 164412
  • New York
    • New York, New York, United States, 10016-6402
      • NYU Langone Medical Center /ID# 164924
  • Ohio
    • Cincinnati, Ohio, United States, 45267-0585
      • University of Cincinnati /ID# 165142
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation /ID# 164413
  • Texas
    • Dallas, Texas, United States, 75251-3831
      • Neurology Consultants of Dallas /ID# 167116

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABBV-951; ABBV-951 administered by continuous subcutaneous infusion (CSCI) for 4 weeks.	Drug: ABBV-951; powder for solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
Percentage of Participants with Markedly Abnormal Vital Signs Values	Vital signs will be collected both supine and standing.	28 days
Columbia-Suicide Severity Rating Scale (C-SSRS)	The C-SSRS is an instrument designed to assess suicidal behavior and ideation.	28 days
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Concentrations of Levodopa	Blood samples for pharmacokinetic assessment will be collected twice at each visit.	Days 1, 7, 14, 21, and 28

Collaborators and Investigators

• Sponsor: AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2018
• Primary Completion (Actual): March 4, 2019
• Study Completion (Actual): March 4, 2019

Study Registration Dates

• First Submitted: December 8, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (Actual): December 15, 2017

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 12, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: levodopa; carbidopa
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: M15-739

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No