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

Phase 1

Completed

• Conditions: Parkinson's Disease (PD)
• Interventions: Drug: ABBV-951

• Registration Number: NCT03374917
• Lead Sponsor: AbbVie

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-12-08
• Study First Submitted QC: 2017-12-12
• Study First Posted: 2017-12-15
• Study Start: 2018-04-18
• Primary Completion: 2019-03-04
• Study Completion: 2019-03-04
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ABBV-951	ABBV-951	ABBV-951 administered by continuous subcutaneous infusion (CSCI) for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Infusion Site Reactions	28 Days	Local tolerability (infusion site evaluation) was assessed using the Infusion Site Assessment 2-part rating scale.
Number of Participants with Adverse Events	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.
Percentage of Participants with Markedly Abnormal Vital Signs Values	28 days	Vital signs will be collected both supine and standing.
Columbia-Suicide Severity Rating Scale (C-SSRS)	28 days	The C-SSRS is an instrument designed to assess suicidal behavior and ideation.
Percentage of Participants with Potentially Clinically Significant Laboratory Values	28 days	Blood samples for serum chemistry tests will be collected following a minimum 8-hour fast.
Percentage of Participants with Potentially Clinically Significant Electrocardiogram (ECG) Results	28 days	A 12-lead ECG will be performed after the participant has been supine for at least 5 minutes.

Secondary Outcome Measures

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

Trial Locations

Locations (12)

Univ Kansas Med Ctr /ID# 166280; 🇺🇸 Kansas City, Kansas, United States

Loma Linda University /ID# 165592; 🇺🇸 Loma Linda, California, United States

Compass Research /ID# 167329; 🇺🇸 Orlando, Florida, United States

Washington University-School of Medicine /ID# 164412; 🇺🇸 Saint Louis, Missouri, United States

NYU Langone Medical Center /ID# 164924; 🇺🇸 New York, New York, United States

Cleveland Clinic Foundation /ID# 164413; 🇺🇸 Cleveland, Ohio, United States

Neurology Consultants of Dallas /ID# 167116; 🇺🇸 Dallas, Texas, United States

University of Cincinnati /ID# 165142; 🇺🇸 Cincinnati, Ohio, United States

Banner Sun Health Res Inst /ID# 165840; 🇺🇸 Sun City, Arizona, United States

Univ CA, Irvine Med Ctr /ID# 165594; 🇺🇸 Orange, California, United States

University of Kentucky Chandler Medical Center /ID# 164407; 🇺🇸 Lexington, Kentucky, United States

University of Louisville /ID# 164997; 🇺🇸 Louisville, Kentucky, United States