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

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified July 2025 by AbbVie
Sponsor
AbbVie
Information Provided by (Responsible Party)
AbbVie
Clinicaltrials.gov Identifier
NCT04750226
Other Study ID Numbers:
M20-098
First Submitted
February 9, 2021
First Posted
February 10, 2021
Last Update Posted
August 11, 2025
Last Verified
July 2025

ClinicalTrials.gov processed this data on August 2025Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Parkinson's Disease (PD)
Drug: ABBV-951

Study Design

Study TypeInterventional
Actual Enrollment118 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleAn 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
Study Start DateFebruary 17, 2021
Actual Primary Completion DateMarch 31, 2026
Actual Study Completion DateMarch 31, 2026

Groups and Cohorts

Group/CohortIntervention/Treatment
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).

Outcome Measures

Primary Outcome Measures
  1. 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.
  2. 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.
  3. 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").
  4. 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").
  5. 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.
  6. 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.
  7. 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.
  8. 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..
  9. 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.
  10. Change From Baseline in Electrocardiograms (ECGs)
    12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.
Secondary Outcome Measures
  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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).
  11. 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.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsAbbVie
Locations
University of Alabama at Birmingham - Main /ID# 217814 | Birmingham Alabama, United States, 35233University of South Alabama /ID# 218467 | Mobile Alabama, United States, 36604-3302Xenoscience, Inc /ID# 222515 | Phoenix Arizona, United States, 85004Muhammad Ali Parkinson Center /ID# 218609 | Phoenix Arizona, United States, 85013-4407Movement Disorders Center of Arizona /ID# 218471 | Scottsdale Arizona, United States, 85258-4582Neuro Pain Medical Center /ID# 217720 | Fresno California, United States, 93710Loma Linda University Medical /ID# 217724 | Loma Linda California, United States, 92354University of California, Los Angeles /ID# 218460 | Los Angeles California, United States, 90095SC3 Research Group - Pasadena /ID# 223018 | Pasadena California, United States, 91105-3149University of California, San /ID# 218595 | San Diego California, United States, 92037Duplicate_Cedars-Sinai Medical Center-West Hollywood /ID# 218607 | West Hollywood California, United States, 90048University of Colorado Hospital /ID# 218486 | Aurora Colorado, United States, 80045Alpine Clinical Research Center /ID# 218461 | Boulder Colorado, United States, 80301-1880Denver Neurological Research, LLC /ID# 217811 | Denver Colorado, United States, 80210-7009CenExel Rocky Mountain Clinical Research, LLC /ID# 217731 | Englewood Colorado, United States, 80113-2736Georgetown University Hospital /ID# 218599 | Washington D.C. District of Columbia, United States, 20007Visionary Investigators Network - Miami /ID# 217726 | Miami Florida, United States, 33176-2148Renstar Medical Research /ID# 217837 | Ocala Florida, United States, 34470Neurology Associates Ormond Beach /ID# 217800 | Ormond Beach Florida, United States, 32174Parkinson's Disease Treatment Center of Southwest Florida /ID# 222679 | Port Charlotte Florida, United States, 33980University of South Florida- Neuroscience Institute /ID# 218481 | Tampa Florida, United States, 33613Premiere Research Institute - Palm Beach /ID# 218743 | West Palm Beach Florida, United States, 33407-3209Rush University Medical Center /ID# 217807 | Chicago Illinois, United States, 60612University of Chicago Medical /ID# 218611 | Chicago Illinois, United States, 60637St Elizabeth's Medical Center - Brighton /ID# 223082 | Brighton Massachusetts, United States, 02135-2907St. Luke's Hosp. of Kansas City /ID# 218604 | Kansas City Missouri, United States, 64111Washington University-School of Medicine /ID# 217723 | St Louis Missouri, United States, 63110Global Neurosciences Institute /ID# 218472 | Lawrenceville New Jersey, United States, 08648-2300Northwell Health /ID# 218600 | Lake Success New York, United States, 11042M3 Wake Research Inc. /ID# 218482 | Raleigh North Carolina, United States, 27612-8106The Orthopedic Foundation /ID# 218608 | New Albany Ohio, United States, 43054-8167The Movement Disorder Clinic of Oklahoma /ID# 218580 | Tulsa Oklahoma, United States, 74136-6378Legacy Medical Group - Neurology /ID# 217804 | Portland Oregon, United States, 97232-2003University of Pennsylvania /ID# 218605 | Philadelphia Pennsylvania, United States, 19104-5502Thomas Jefferson University Hospital /ID# 218594 | Philadelphia Pennsylvania, United States, 19107Prisma Health-Upstate /ID# 217803 | Greenville South Carolina, United States, 29615Coastal Neurology /ID# 222893 | Port Royal South Carolina, United States, 29935-2029KCA Neurology - Franklin /ID# 222811 | Franklin Tennessee, United States, 37067-5914Vanderbilt University Medical Center /ID# 217722 | Nashville Tennessee, United States, 37232-0011St. David's Healthcare Partnership, L.P., LLP /ID# 248148 | Austin Texas, United States, 78701-4082Houston Pulmonary Sleep and Allergy Associates /ID# 218473 | Cypress Texas, United States, 77429Texas Movement Disorder Specialists /ID# 218610 | Georgetown Texas, United States, 78628-4126Baylor College of Medicine /ID# 217728 | Houston Texas, United States, 77030University of Utah Health Care /ID# 218597 | Salt Lake City Utah, United States, 84132Neurological Associates - Forest Ave /ID# 218458 | Richmond Virginia, United States, 23229-4913Inland Northwest Research /ID# 222520 | Spokane Washington, United States, 99202-1342Duplicate_Medical College of Wisconsin /ID# 217721 | Milwaukee Wisconsin, United States, 53226-3522Liverpool Hospital /ID# 221693 | Liverpool New South Wales, Australia, 2170Westmead Hospital /ID# 218418 | Westmead New South Wales, Australia, 2145Gold coast University Hospital /ID# 221694 | Southport Queensland, Australia, 4215Royal Adelaide Hospital /ID# 218417 | Adelaide South Australia, Australia, 5000The Royal Melbourne Hospital /ID# 218419 | Parkville Victoria, Australia, 3050
Investigators
Study Director: ABBVIE INC., AbbVie