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
- Registration Number
- NCT04750226
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 118
- Completion of the parent study, Study M15-736 or Study M20-339.
- Participant considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ABBV-951 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.
- Primary Outcome Measures
Name Time Method Change From Baseline in Impulsive-Compulsive Disorders and related behaviors as assessed in Parkinson's Disease- Rating Scale (QUIP-RS) Up To Week 96 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.
Percentage of Participants with Adverse Event (AEs) Up to Week 96 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.
Percentage of Participants with AEs of Special Interest (AESIs) Up to Week 96 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.
Percentage Of Participants With Letter Grade Equal To Or Higher Than D On The Infusion Site Evaluation Scale Up To Week 96 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").
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 Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Change From Baseline in Electrocardiograms (ECGs) Up to Week 96 12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.
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 in clinical laboratory test results like hematology will be assessed..
Percentage Of Participants With Numeric Grade Equal To Or Higher Than 5 On The Infusion Site Evaluation Scale Up To Week 96 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").
Change From Baseline in Suicidality as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) Up To Week 96 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.
Change From Baseline in Cognitive Impairment as Assessed by the Mini-Mental State Examination (MMSE) Up To Week 96 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Motor Experiences of Daily Living Up To Week 96 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.
Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Parts I-III Up To Week 96 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.
Percentage Of Participants With Early Morning "Off" Assessed by the PD Diary as Percentage of Participants with early morning "Off" Upon Waking Up Up To Week 96 Early morning "Off" status is assessed by the PD Diary as percentage of participants with early morning "Off" upon waking up.
Change From Baseline in Average Normalized "On" Time as Assessed by the Parkinson's Disease (PD) Diary Up To Week 96 Change in "On" time without dyskinesia or with non-troublesome dyskinesia as assessed by the PD diary.
Change From Baseline in Average Daily Normalized "Off" Time as Assessed by the PD Diary Up To Week 96 Change in average daily normalized "Off" Time (Hours) is assessed based on PD Diary.
Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part I Up To Week 96 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.
Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part III Up To Week 96 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.
Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part IV Up To Week 96 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.
Change From Baseline in Sleep Symptoms Up To Week 96 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.
Change From Baseline in Quality Of Life as Assessed by the PD Questionnaire-39 item (PDQ-39) Up To Week 96 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.
Change From Baseline in Health-related Quality of Life as Assessed by EQ-5D-5L Up To Week 96 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).
Trial Locations
- Locations (52)
University of South Alabama /ID# 218467
šŗšøMobile, Alabama, United States
Thomas Jefferson University Hospital /ID# 218594
šŗšøPhiladelphia, Pennsylvania, United States
Visionary Investigators Network - Miami /ID# 217726
šŗšøMiami, Florida, United States
Rush University Medical Center /ID# 217807
šŗšøChicago, Illinois, United States
University of Chicago Medical /ID# 218611
šŗšøChicago, Illinois, United States
University of California, San /ID# 218595
šŗšøSan Diego, California, United States
Vanderbilt University Medical Center /ID# 217722
šŗšøNashville, Tennessee, United States
University of Alabama at Birmingham - Main /ID# 217814
šŗšøBirmingham, Alabama, United States
Denver Neurological Research, LLC /ID# 217811
šŗšøDenver, Colorado, United States
Legacy Medical Group - Neurology /ID# 217804
šŗšøPortland, Oregon, United States
University of California, Los Angeles /ID# 218460
šŗšøLos Angeles, California, United States
Parkinson's Disease Treatment Center of Southwest Florida /ID# 222679
šŗšøPort Charlotte, Florida, United States
Neuro Pain Medical Center /ID# 217720
šŗšøFresno, California, United States
Loma Linda University Medical /ID# 217724
šŗšøLoma Linda, California, United States
Alpine Clinical Research Center /ID# 218461
šŗšøBoulder, Colorado, United States
CenExel Rocky Mountain Clinical Research, LLC /ID# 217731
šŗšøEnglewood, Colorado, United States
Renstar Medical Research /ID# 217837
šŗšøOcala, Florida, United States
Westmead Hospital /ID# 218418
š¦šŗWestmead, New South Wales, Australia
Gold coast University Hospital /ID# 221694
š¦šŗSouthPort, Queensland, Australia
Houston Pulmonary Sleep and Allergy Associates /ID# 218473
šŗšøCypress, Texas, United States
The Royal Melbourne Hospital /ID# 218419
š¦šŗParkville, Victoria, Australia
Liverpool Hospital /ID# 221693
š¦šŗLiverpool, New South Wales, Australia
Royal Adelaide Hospital /ID# 218417
š¦šŗAdelaide, South Australia, Australia
Texas Movement Disorder Specialists /ID# 218610
šŗšøGeorgetown, Texas, United States
University of Utah Health Care /ID# 218597
šŗšøSalt Lake City, Utah, United States
The Movement Disorder Clinic of Oklahoma /ID# 218580
šŗšøTulsa, Oklahoma, United States
SC3 Research Group - Pasadena /ID# 223018
šŗšøPasadena, California, United States
Neurology Associates Ormond Beach /ID# 217800
šŗšøOrmond Beach, Florida, United States
St Elizabeth's Medical Center - Brighton /ID# 223082
šŗšøBrighton, Massachusetts, United States
M3 Wake Research Inc. /ID# 218482
šŗšøRaleigh, North Carolina, United States
University of Pennsylvania /ID# 218605
šŗšøPhiladelphia, Pennsylvania, United States
Baylor College of Medicine - Baylor Medical Center /ID# 217728
šŗšøHouston, Texas, United States
Inland Northwest Research /ID# 222520
šŗšøSpokane, Washington, United States
Northwell Health /ID# 218600
šŗšøLake Success, New York, United States
Premiere Research Institute - Palm Beach /ID# 218743
šŗšøWest Palm Beach, Florida, United States
Washington University-School of Medicine /ID# 217723
šŗšøSaint Louis, Missouri, United States
Cedars-Sinai Medical Center-West Hollywood /ID# 218607
šŗšøWest Hollywood, California, United States
The Orthopedic Foundation /ID# 218608
šŗšøNew Albany, Ohio, United States
Xenoscience, Inc /ID# 222515
šŗšøPhoenix, Arizona, United States
Global Neurosciences Institute /ID# 218472
šŗšøLawrenceville, New Jersey, United States
Muhammad Ali Parkinson Center /ID# 218609
šŗšøPhoenix, Arizona, United States
Coastal Neurology /ID# 222893
šŗšøPort Royal, South Carolina, United States
Movement Disorders Center of Arizona /ID# 218471
šŗšøScottsdale, Arizona, United States
Georgetown University Hospital /ID# 218599
šŗšøWashington, District of Columbia, United States
KCA Neurology - Franklin /ID# 222811
šŗšøFranklin, Tennessee, United States
Prisma Health-Upstate /ID# 217803
šŗšøGreenville, South Carolina, United States
St. Luke's Hosp. of Kansas City /ID# 218604
šŗšøKansas City, Missouri, United States
University of South Florida /ID# 218481
šŗšøTampa, Florida, United States
University of Colorado Hospital /ID# 218486
šŗšøAurora, Colorado, United States
Neurological Associates - Forest Ave /ID# 218458
šŗšøRichmond, Virginia, United States
Medical College of Wisconsin /ID# 217721
šŗšøMilwaukee, Wisconsin, United States
St. David's Healthcare Partnership, L.P., LLP /ID# 248148
šŗšøAustin, Texas, United States