Study To Assess Adverse Events and Change in Disease Activity Of 24-hour Continuous Subcutaneous Infusion Of ABBV-951 In Adult Participants With Advanced Parkinson's Disease

An Open-Label Extension of Studies M15-736 and M20-339 to Evaluate the Safety and Tolerability of 24-Hour Daily Exposure of ABBV-951 in Subjects With Advanced Parkinson's Disease

Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study will assess how safe and effective ABBV-951 is in adult participants with PD. Adverse events and change in disease activity is evaluated.

ABBV-951 is an investigational (unapproved) drug containing Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP) given as an infusion under the skin for the treatment of Parkinson's Disease. Adult participants with advanced PD and who have completed M15-736 or M20-339 study will be enrolled. Approximately 130 participants will be enrolled in the study in approximately 60 sites in the United States and Australia.

Participants will receive continuous subcutaneous infusion (CSCI) (under the skin) of ABBV-951 for 96 weeks during the Primary Treatment Period and during the optional Extended Treatment Period.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical and remote telephone assessments, blood tests, checking for side effects, and completing questionnaires.

Study Overview

• Status: Active, not recruiting
• Conditions: Parkinson's Disease (PD)
• Intervention / Treatment: Drug: ABBV-951

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Liverpool, New South Wales, Australia, 2170
      • Liverpool Hospital /ID# 221693
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital /ID# 218418
  • Queensland
    • SouthPort, Queensland, Australia, 4215
      • Gold coast University Hospital /ID# 221694
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital /ID# 218417
  • Victoria
    • Parkville, Victoria, Australia, 3050
      • The Royal Melbourne Hospital /ID# 218419
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham - Main /ID# 217814
    • Mobile, Alabama, United States, 36604-3302
      • University of South Alabama /ID# 218467
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Xenoscience, Inc /ID# 222515
    • Phoenix, Arizona, United States, 85013-4407
      • Muhammad Ali Parkinson Center /ID# 218609
    • Scottsdale, Arizona, United States, 85258-4582
      • Movement Disorders Center of Arizona /ID# 218471
  • California
    • Fresno, California, United States, 93710-5473
      • Neuro Pain Medical Center /ID# 217720
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical /ID# 217724
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles /ID# 218460
    • Pasadena, California, United States, 91105-3149
      • SC3 Research Group - Pasadena /ID# 223018
    • San Diego, California, United States, 92037
      • University of California, San /ID# 218595
    • West Hollywood, California, United States, 90048
      • Cedars-Sinai Medical Center-West Hollywood /ID# 218607
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital /ID# 218486
    • Boulder, Colorado, United States, 80301-1880
      • Alpine Clinical Research Center /ID# 218461
    • Denver, Colorado, United States, 80210-7009
      • Denver Neurological Research, LLC /ID# 217811
    • Englewood, Colorado, United States, 80113-2736
      • CenExel Rocky Mountain Clinical Research, LLC /ID# 217731
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Hospital /ID# 218599
  • Florida
    • Miami, Florida, United States, 33176-2148
      • Visionary Investigators Network - Miami /ID# 217726
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research /ID# 217837
    • Ormond Beach, Florida, United States, 32174
      • Neurology Associates Ormond Beach /ID# 217800
    • Port Charlotte, Florida, United States, 33980
      • Parkinson's Disease Treatment Center of Southwest Florida /ID# 222679
    • Tampa, Florida, United States, 33612
      • University of South Florida /ID# 218481
    • West Palm Beach, Florida, United States, 33407-3209
      • Premiere Research Institute - Palm Beach /ID# 218743
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center /ID# 217807
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical /ID# 218611
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135-2907
      • St Elizabeth's Medical Center - Brighton /ID# 223082
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hosp. of Kansas City /ID# 218604
    • Saint Louis, Missouri, United States, 63110
      • Washington University-School of Medicine /ID# 217723
  • New Jersey
    • Lawrenceville, New Jersey, United States, 08648-2300
      • Global Neurosciences Institute /ID# 218472
  • New York
    • Lake Success, New York, United States, 11042
      • Northwell Health /ID# 218600
  • North Carolina
    • Raleigh, North Carolina, United States, 27612-8106
      • M3 Wake Research Inc. /ID# 218482
  • Ohio
    • New Albany, Ohio, United States, 43054-8167
      • The Orthopedic Foundation /ID# 218608
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136-6378
      • The Movement Disorder Clinic of Oklahoma /ID# 218580
  • Oregon
    • Portland, Oregon, United States, 97232-2003
      • Legacy Medical Group - Neurology /ID# 217804
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-5502
      • University of Pennsylvania /ID# 218605
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital /ID# 218594
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Prisma Health-Upstate /ID# 217803
    • Port Royal, South Carolina, United States, 29935-2029
      • Coastal Neurology /ID# 222893
  • Tennessee
    • Franklin, Tennessee, United States, 37067-5914
      • KCA Neurology - Franklin /ID# 222811
    • Nashville, Tennessee, United States, 37232-0011
      • Vanderbilt University Medical Center /ID# 217722
  • Texas
    • Austin, Texas, United States, 78701-4082
      • St. David's Healthcare Partnership, L.P., LLP /ID# 248148
    • Cypress, Texas, United States, 77429
      • Houston Pulmonary Sleep and Allergy Associates /ID# 218473
    • Georgetown, Texas, United States, 78628-4126
      • Texas Movement Disorder Specialists /ID# 218610
    • Houston, Texas, United States, 77030-3411
      • Baylor College of Medicine - Baylor Medical Center /ID# 217728
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Health Care /ID# 218597
  • Virginia
    • Richmond, Virginia, United States, 23229-4913
      • Neurological Associates - Forest Ave /ID# 218458
  • Washington
    • Spokane, Washington, United States, 99202-1342
      • Inland Northwest Research /ID# 222520
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226-3522
      • Medical College of Wisconsin /ID# 217721

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- Completion of the parent study, Study M15-736 or Study M20-339.

Exclusion Criteria:

- Participant considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason.

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; Participants will receive ABBV-951 by continuous subcutaneous infusion (CSCI) for 96 weeks during the Primary Treatment Period and during the optional Extended Treatment Period.	Drug: ABBV-951; Solution for continuous subcutaneous infusion (CSCI).; Other Names: Foscarbidopa; Foslevodopa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Adverse Event (AEs)	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An SAE is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.	Up to Week 96
Percentage of Participants with AEs of Special Interest (AESIs)	AESIs are defined as AEs from "special situations," such as accidental or intentional overdose, medication error, occupational or accidental exposure, off-label use, drug abuse, drug misuse, or drug withdrawal, all which must be reported whether associated with an AE or not.	Up to Week 96
Percentage Of Participants With Numeric Grade Equal To Or Higher Than 5 On The Infusion Site Evaluation Scale	The Infusion Site Evaluation Scale will be used to assess infusion sites. Infusion Site Evaluation Scale is an eight-point numeric scale used to assess irritation at the infusion site area (0 being "no evidence of irritation" and 7 being "strong reaction spreading beyond the test site").	Up To Week 96
Percentage Of Participants With Letter Grade Equal To Or Higher Than D On The Infusion Site Evaluation Scale	The Infusion Site Evaluation Scale will be used to assess infusion sites. Infusion Site Evaluation Scale is an A to G letter grade scale, used to assess irritation at the infusion site area (A being "no finding" to G being "Small petechial erosions and/or scabs").	Up To Week 96
Change From Baseline in Suicidality as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)	C-SSRS is a systematically administered instrument designed to assess suicidal behavior and ideation, track and assess all suicidal events, and assess the lethality of attempts. Any participant who has suicidal behavior or suicidal ideation with plan since the last C-SSRS completed, will be evaluated immediately by the investigator.	Up To Week 96
Change From Baseline in Impulsive-Compulsive Disorders and related behaviors as assessed in Parkinson's Disease- Rating Scale (QUIP-RS)	The QUIP-RS is a brief, self-completed or rater-administered rating scale to assess the severity of symptoms of impulse control disorders (ICDs) and related behaviors reported to occur in PD. The QUIP-RS uses a 5-point Likert scale that requires individuals to rate the severity of each symptom based on its frequency.	Up To Week 96
Change From Baseline in Cognitive Impairment as Assessed by the Mini-Mental State Examination (MMSE)	Cognitive impairment is assessed by the Mini-Mental State Examination (MMSE). MMSE is a brief 30-point questionnaire, administered by a trained rater, that provides a quantitative measure of cognitive status in adults and is used widely to screen for cognitive impairment and to estimate the severity of cognitive impairment at a given point in time, to follow the course of changes in a patient over time, and to document response to treatment.	Up To Week 96
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed.	Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed..	Up to Week 96
Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements like Systolic and Diastolic Blood Pressure will be Assessed	Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.	Up to Week 96
Change From Baseline in Electrocardiograms (ECGs)	12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.	Up to Week 96

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Average Normalized "On" Time as Assessed by the Parkinson's Disease (PD) Diary	Change in "On" time without dyskinesia or with non-troublesome dyskinesia as assessed by the PD diary.	Up To Week 96
Change From Baseline in Average Daily Normalized "Off" Time as Assessed by the PD Diary	Change in average daily normalized "Off" Time (Hours) is assessed based on PD Diary.	Up To Week 96
Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part I	The MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD) with scores ranging from 0 to 236 with 236 representing the worst disability, and 0 representing no disability.	Up To Week 96
Change From Baseline in Motor Experiences of Daily Living	Motor experiences of daily living is assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II. The MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD) with scores ranging from 0 to 236 with 236 representing the worst disability, and 0 representing no disability.	Up To Week 96
Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part III	The MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD) with scores ranging from 0 to 236 with 236 representing the worst disability, and 0 representing no disability.	Up To Week 96
Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part IV	The MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD) with scores ranging from 0 to 236 with 236 representing the worst disability, and 0 representing no disability.	Up To Week 96
Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Parts I-III	The MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD) with scores ranging from 0 to 236 with 236 representing the worst disability, and 0 representing no disability.	Up To Week 96
Change From Baseline in Sleep Symptoms	Sleep symptoms are assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2). The PDSS-2 consists of 15 questions that evaluate motor and non-motor symptoms at night and upon wakening, as well as disturbed sleep.	Up To Week 96
Change From Baseline in Quality Of Life as Assessed by the PD Questionnaire-39 item (PDQ-39)	Quality of life is assessed by the PD Questionnaire-39 item (PDQ-39). PDQ-39 is a disease-specific instrument designed to measure aspects of health that are relevant to participants with PD, and which may not be included in general health status questionnaires. Each item is scored on a 5-point scale.	Up To Week 96
Change From Baseline in Health-related Quality of Life as Assessed by EQ-5D-5L	Health-related quality of life is assessed by EQ-5D-5L. EQ-5D-5L is a standardized instrument that consists of 2 parts: the EQ-5D descriptive system and the EQ visual analogue-scale (EQ-VAS).	Up To Week 96
Percentage Of Participants With Early Morning "Off" Assessed by the PD Diary as Percentage of Participants with early morning "Off" Upon Waking Up	Early morning "Off" status is assessed by the PD Diary as percentage of participants with early morning "Off" upon waking up.	Up To Week 96

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2021
• Primary Completion (Estimated): May 16, 2025
• Study Completion (Estimated): May 16, 2025

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Estimated): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 4, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Parkinson's Disease; PD; ABBV-951; Levodopa/Carbidopa (LD/CD); Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP)
• 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: M20-098; 2019-004204-35 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

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.: Yes