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

NCT04750226 | Completed Phase 3 FDA Drug

• 2 other identifiers: M20-0982019-004204-35
• Study Type: interventional
• Target: 118
• Locations: 2 countries
• Sites: 52

Brief Summary

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.

Conditions

Parkinson's Disease (PD)

Keywords

Parkinson's Disease; PD; ABBV-951; Levodopa/Carbidopa (LD/CD); Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP)

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (11)

• Change From Baseline in Average Normalized "On" Time as Assessed by the Parkinson's Disease (PD) Diary

  Up To Week 96

• Change From Baseline in Average Daily Normalized "Off" Time as Assessed by the PD Diary

  Up To Week 96

• Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part I

  Up To Week 96

• Change From Baseline in Motor Experiences of Daily Living

  Up To Week 96

• Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part III

  Up To Week 96

Study Arms (1)

ABBV-951

EXPERIMENTAL

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

Interventions

ABBV-951 DRUG

Solution for continuous subcutaneous infusion (CSCI).

Also known as: Foscarbidopa, Foslevodopa

ABBV-951

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (52)

University of Alabama at Birmingham - Main /ID# 217814

Birmingham, Alabama, 35233, United States

Location

Usa Mitchell Cancer Institute /ID# 218467

Mobile, Alabama, 36604, United States

Location

Xenoscience, Inc /ID# 222515

Phoenix, Arizona, 85004, United States

Location

Muhammad Ali Parkinson Center /ID# 218609

Phoenix, Arizona, 85013-4407, United States

Location

Movement Disorders Center of Arizona /ID# 218471

Scottsdale, Arizona, 85258-4582, United States

Location

Neuro Pain Research Center /ID# 217720

Fresno, California, 93710, United States

Location

Loma Linda University Medical /ID# 217724

Loma Linda, California, 92354, United States

Location

University of California, Los Angeles /ID# 218460

Los Angeles, California, 90095, United States

Location

SC3 Research Group - Pasadena /ID# 223018

Pasadena, California, 91105-3149, United States

Location

University of California, San /ID# 218595

San Diego, California, 92037, United States

Location

Duplicate_Cedars-Sinai Medical Center-West Hollywood /ID# 218607

West Hollywood, California, 90048, United States

Location

University of Colorado Hospital /ID# 218486

Aurora, Colorado, 80045, United States

Location

Alpine Clinical Research Center /ID# 218461

Boulder, Colorado, 80301-1880, United States

Location

Denver Neurological Research, LLC /ID# 217811

Denver, Colorado, 80210-7009, United States

Location

CenExel Rocky Mountain Clinical Research, LLC /ID# 217731

Englewood, Colorado, 80113-2736, United States

Location

Georgetown University Hospital /ID# 218599

Washington D.C., District of Columbia, 20007, United States

Location

Visionary Investigators Network - Miami /ID# 217726

Miami, Florida, 33176-2148, United States

Location

Renstar Medical Research /ID# 217837

Ocala, Florida, 34470, United States

Location

Neurology Associates Ormond Beach /ID# 217800

Ormond Beach, Florida, 32174, United States

Location

Parkinson's Disease Treatment Center of Southwest Florida /ID# 222679

Port Charlotte, Florida, 33980, United States

Location

University of South Florida- Neuroscience Institute /ID# 218481

Tampa, Florida, 33613, United States

Location

Premiere Research Institute - Palm Beach /ID# 218743

West Palm Beach, Florida, 33407-3209, United States

Location

Rush University Medical Center /ID# 217807

Chicago, Illinois, 60612, United States

Location

University of Chicago Medical Center /ID# 218611

Chicago, Illinois, 60637, United States

Location

St Elizabeth's Medical Center - Brighton /ID# 223082

Brighton, Massachusetts, 02135-2907, United States

Location

St. Lukes Hosp. of Kansas City /ID# 218604

Kansas City, Missouri, 64111, United States

Location

Washington University-School of Medicine /ID# 217723

St Louis, Missouri, 63110, United States

Location

Global Neurosciences Institute /ID# 218472

Lawrenceville, New Jersey, 08648-2300, United States

Location

Northwell Health /ID# 218600

Lake Success, New York, 11042, United States

Location

M3 Wake Research - Raleigh /ID# 218482

Raleigh, North Carolina, 27612-8106, United States

Location

The Orthopedic Foundation /ID# 218608

New Albany, Ohio, 43054-8167, United States

Location

The Movement Disorder Clinic of Oklahoma /ID# 218580

Tulsa, Oklahoma, 74136-6378, United States

Location

Legacy Medical Group - Neurology /ID# 217804

Portland, Oregon, 97232-2003, United States

Location

University of Pennsylvania /ID# 218605

Philadelphia, Pennsylvania, 19104-5502, United States

Location

Thomas Jefferson University Hospital /ID# 218594

Philadelphia, Pennsylvania, 19107, United States

Location

Prisma Health-Upstate /ID# 217803

Greenville, South Carolina, 29615, United States

Location

Coastal Neurology /ID# 222893

Port Royal, South Carolina, 29935-2029, United States

Location

KCA Neurology - Franklin /ID# 222811

Franklin, Tennessee, 37067-5914, United States

Location

Vanderbilt University Medical Center /ID# 217722

Nashville, Tennessee, 37232-0011, United States

Location

St. David's Healthcare Partnership, L.P., LLP /ID# 248148

Austin, Texas, 78701-4082, United States

Location

Houston Pulmonary Sleep and Allergy Associates /ID# 218473

Cypress, Texas, 77429, United States

Location

Texas Movement Disorder Specialists /ID# 218610

Georgetown, Texas, 78628-4126, United States

Location

Baylor College of Medicine /ID# 217728

Houston, Texas, 77030, United States

Location

University of Utah Health Care /ID# 218597

Salt Lake City, Utah, 84132, United States

Location

Neurological Associates - Forest Ave /ID# 218458

Richmond, Virginia, 23229-4913, United States

Location

Inland Northwest Research /ID# 222520

Spokane, Washington, 99202-1342, United States

Location

Duplicate_Medical College of Wisconsin /ID# 217721

Milwaukee, Wisconsin, 53226-3522, United States

Location

Liverpool Hospital /ID# 221693

Liverpool, New South Wales, 2170, Australia

Location

Westmead Hospital /ID# 218418

Westmead, New South Wales, 2145, Australia

Location

Gold coast University Hospital /ID# 221694

Southport, Queensland, 4215, Australia

Location

Royal Adelaide Hospital /ID# 218417

Adelaide, South Australia, 5000, Australia

Location

The Royal Melbourne Hospital /ID# 218419

Parkville, Victoria, 3050, Australia

Location

Related Publications (1)

• Soileau M, Kumar R, Parab A, Brion T, White K, Yan CH, Shah MB, Kukreja P, Facheris MF, Shewale A, Aldred J. Patients' experience with and perspectives on long-term use of continuous subcutaneous infusion of foslevodopa/foscarbidopa in Parkinson's disease. J Neurol. 2025 May 22;272(6):416. doi: 10.1007/s00415-025-13123-y.

  PMID: 40402298 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 11, 2021
• Study Start: February 18, 2021
• Primary Completion: April 27, 2026
• Study Completion: April 27, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

AU (5); US (47)