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

• ClinicalTrials.gov Identifier: NCT03374917
• Recruitment Status: Completed
• First Posted: December 15, 2017
• Last Update Posted: March 13, 2019
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Parkinson's Disease (PD)	Drug: ABBV-951	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: April 18, 2018
• Actual Primary Completion Date: March 4, 2019
• Actual Study Completion Date: March 4, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, Arizona

Banner Sun Health Res Inst /ID# 165840

Sun City, Arizona, United States, 85351

United States, California

Loma Linda University /ID# 165592

Loma Linda, California, United States, 92354

Univ CA, Irvine Med Ctr /ID# 165594

Orange, California, United States, 92868

United States, Florida

Compass Research /ID# 167329

Orlando, Florida, United States, 32806

United States, Kansas

Univ Kansas Med Ctr /ID# 166280

Kansas City, Kansas, United States, 66160

United States, Kentucky

University of Kentucky Chandler Medical Center /ID# 164407

Lexington, Kentucky, United States, 40536

University of Louisville /ID# 164997

Louisville, Kentucky, United States, 40202

United States, Missouri

Washington University-School of Medicine /ID# 164412

Saint Louis, Missouri, United States, 63110

United States, New York

NYU Langone Medical Center /ID# 164924

New York, New York, United States, 10016-6402

United States, Ohio

University of Cincinnati /ID# 165142

Cincinnati, Ohio, United States, 45267-0585

Cleveland Clinic Foundation /ID# 164413

Cleveland, Ohio, United States, 44195

United States, Texas

Neurology Consultants of Dallas /ID# 167116

Dallas, Texas, United States, 75251-3831

Sponsors and Collaborators

AbbVie

Investigators

• Study Director: AbbVie Inc.; AbbVie

More Information

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT03374917
• Other Study ID Numbers: M15-739
• First Posted: December 15, 2017
• Last Update Posted: March 13, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by AbbVie:

carbidopa; levodopa

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases