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A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD) | Clinical Trials | Clareo Health

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A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)

A 52-Week, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's Disease

NCT03781167•AbbVie

View on ClinicalTrials.gov

Summary

The purpose of this study was to assess the safety and tolerability of ABBV-951 (Foslevodopa/Foscarbidopa) in participants with Parkinson's disease (PD). This was a single-arm study with preplanned analyses conducted by dose subgroup (Low Dose or High Dose) based on the modal total daily dose (most frequent dose) over the treatment period.

Eligibility

Age

30 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants with diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa-responsive
•Participants must be judged by the investigator to be inadequately controlled by current therapy, have recognizable/identifiable "Off" and "On" states (motor fluctuations), and have a minimum of 2.5 hours of "Off" time per day

Exclusion Criteria

•Participant is cognitively impaired and is not able to safely and effectively manage the drug delivery system and the diaries and is not able to adhere to the study
•Participant is considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason

Locations (65)

University of Alabama at Birmingham - Main /ID# 207996

Birmingham, Alabama, United States

Banner Sun Health Res Inst /ID# 208811

Sun City, Arizona, United States

The Parkinson's & Movement Disorder Institute - Fountain Valley /ID# 216126

Fountain Valley, California, United States

University of Colorado Hospital /ID# 207968

Aurora, Colorado, United States

Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 207677

Boca Raton, Florida, United States

Northwestern University Feinberg School of Medicine /ID# 208812

Chicago, Illinois, United States

Indiana Clinical Research Cent /ID# 207952

Indianapolis, Indiana, United States

Univ Kansas Med Ctr /ID# 208963

Kansas City, Kansas, United States

University of Kentucky Chandler Medical Center /ID# 207603

Lexington, Kentucky, United States

Massachusetts General Hospital /ID# 207993

Boston, Massachusetts, United States

Key Dates

Start Date

April 29, 2019

Primary Completion Date

August 17, 2022

Completion Date

August 17, 2022

Last Updated

October 23, 2023

Enrollment

244

ACTUAL participants

Conditions

Parkinson's Disease (PD)

Interventions

ABBV-951

DRUG

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

NCT07310264

Healthy Volunteers (HV)Parkinson's Disease (PD)

View study

RECRUITINGNA

LIFUS For Neurological Disorders

NCT07417280

Parkinson's Disease (PD)Essential Tremor+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 23, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)

Inclusion Criteria

Exclusion Criteria

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

LIFUS For Neurological Disorders

Real-World Study of ABBV-951 Subcutaneous Infusion to Assess Change in Disease Activity in Adult Participants With Parkinson's Disease

A Phase 2 Study to Assess the Effects of SUL-238 on High Energy Phosphates With ³¹P-MRS in Patients With Early, Untreated Parkinson's Disease

Novel DBS Device in Parkinson's Disease

Health Related Quality of Life in LCIG Patients and LCIG Eligible Patients Continuing Oral Therapy