Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations In Adult Participants With Advanced Parkinson's Disease

A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients

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 measures the efficacy, safety, and tolerability of ABBV-951 versus oral Levodopa (LD)/Carbidopa (CD) [LD/CD] in advanced PD participants to achieve reduction in motor fluctuations.

ABBV-951 is an investigational (unapproved) drug containing Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP) given subcutaneously (under the skin) for the treatment of Parkinson's Disease. Adult participants with advanced PD will be enrolled. Approximately 130 participants will be enrolled in the study in approximately 80 sites across the world.

In one arm, participants will receive ABBV-951 solution as a continuous infusion under the skin plus oral placebo capsules for LD/CD. In the second arm, participants will receive placebo solution for ABBV-951 as a continuous infusion under the skin plus oral capsules containing LD/CD tablets. The treatment duration is 12 weeks.

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 assessments, blood tests, checking for side effects, and completing questionnaires.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease (PD)
• Intervention / Treatment: Drug: ABBV-951; Drug: Placebo for Levodopa/Carbidopa (LD/CD); Drug: Levodopa/Carbidopa (LD/CD); Drug: Placebo for ABBV-951

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Liverpool, New South Wales, Australia, 2170
      • Liverpool Hospital /ID# 218681
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital /ID# 216535
  • Queensland
    • SouthPort, Queensland, Australia, 4215
      • Gold coast University Hospital /ID# 218373
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital /ID# 216533
  • Victoria
    • Cheltenham, Victoria, Australia, 3192
      • Kingston Centre /ID# 216537
    • Parkville, Victoria, Australia, 3050
      • The Royal Melbourne Hospital /ID# 216536
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham - Main /ID# 216595
    • Mobile, Alabama, United States, 36604-3302
      • University of South Alabama /ID# 216757
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Xenoscience, Inc /ID# 217110
    • Phoenix, Arizona, United States, 85013-4407
      • Barrow Neurological Institute /ID# 216566
    • Phoenix, Arizona, United States, 85018-2111
      • HonorHealth /ID# 216642
    • Scottsdale, Arizona, United States, 85258-4582
      • Movement Disorders Center of Arizona /ID# 216503
    • Sun City, Arizona, United States, 85351
      • Banner Sun Health Res Inst /ID# 216507
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences /ID# 216501
  • California
    • Fountain Valley, California, United States, 92708
      • The Parkinson's & Movement Disorder Institute - Fountain Valley /ID# 216705
    • Fresno, California, United States, 93710-5473
      • Neuro Pain Medical Center /ID# 216551
    • La Jolla, California, United States, 92093
      • University of California, San /ID# 216598
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical /ID# 216500
    • Long Beach, California, United States, 90806
      • Collaborative Neuroscience Research - Long Beach /ID# 216970
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles /ID# 216674
    • Pasadena, California, United States, 91105-3149
      • SC3 Research Group - Pasadena /ID# 216821
    • West Hollywood, California, United States, 90048
      • Cedars-Sinai Medical Center-West Hollywood /ID# 216561
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital /ID# 216527
    • Boulder, Colorado, United States, 80301-1880
      • Alpine Clinical Research Center /ID# 216637
    • Denver, Colorado, United States, 80210-7009
      • Denver Neurological Research, LLC /ID# 216784
    • Englewood, Colorado, United States, 80113-2736
      • Rocky Mountain Movement Disorders Center /ID# 216737
  • Delaware
    • Newark, Delaware, United States, 19713
      • Christiana Care Health Service /ID# 216515
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Hospital /ID# 216632
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 216517
    • Delray Beach, Florida, United States, 33445
      • Brain Matters Research /ID# 217089
    • Gainesville, Florida, United States, 32608-3928
      • Fixel Institute for Neurological Diseases /ID# 216514
    • Miami, Florida, United States, 33176-2148
      • Visionary Investigators Network - Miami /ID# 216679
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research /ID# 216765
    • Ormond Beach, Florida, United States, 32174
      • Neurology Associates Ormond Beach /ID# 216521
    • Port Charlotte, Florida, United States, 33980
      • Parkinson's Disease Treatment Center of Southwest Florida /ID# 222656
    • Tampa, Florida, United States, 33612
      • University of South Florida /ID# 216638
    • West Palm Beach, Florida, United States, 33407-3209
      • Premiere Research Institute - Palm Beach /ID# 217207
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Duplicate_Atlanta Center for Medical Res /ID# 217091
    • Gainesville, Georgia, United States, 30501
      • The Neurological Center of North Georgia /ID# 216499
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center /ID# 216567
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical /ID# 217187
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana Clinical Research Cent /ID# 216615
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Univ Kansas Med Ctr /ID# 216528
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135-2907
      • St Elizabeth's Medical Center - Brighton /ID# 216716
  • Michigan
    • East Lansing, Michigan, United States, 48824
      • Michigan State University /ID# 217158
  • Missouri
    • Chesterfield, Missouri, United States, 63005-1205
      • Clinical Research Professionals - Chesterfield /ID# 216669
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hosp. of Kansas City /ID# 216633
    • Saint Louis, Missouri, United States, 63110
      • Washington University-School of Medicine /ID# 216548
  • New Jersey
    • Lawrenceville, New Jersey, United States, 08648-2300
      • Global Neurosciences Institute /ID# 217875
  • New York
    • Lake Success, New York, United States, 11042
      • Northwell Health /ID# 216833
    • New York, New York, United States, 10003
      • Mount Sinai Beth Israel /ID# 216712
    • Rochester, New York, United States, 14642-0001
      • University of Rochester /ID# 218737
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Univ HS /ID# 216522
  • Ohio
    • Columbus, Ohio, United States, 43210-1229
      • Ohio State University - Wexner Medical Center /ID# 216900
    • New Albany, Ohio, United States, 43054-8167
      • The Orthopedic Foundation /ID# 217157
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136-6378
      • The Movement Disorder Clinic of Oklahoma /ID# 216860
  • Oregon
    • Portland, Oregon, United States, 97232-2003
      • Legacy Research Institute /ID# 216558
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-5502
      • University of Pennsylvania /ID# 216560
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital /ID# 216553
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Prisma Health-Upstate /ID# 216594
    • Greer, South Carolina, United States, 29650
      • Premier Neurology, P.C. /ID# 217308
    • Port Royal, South Carolina, United States, 29935-2029
      • Coastal Neurology /ID# 217190
  • Tennessee
    • Franklin, Tennessee, United States, 37067-5914
      • KCA Neurology - Franklin /ID# 217419
    • Nashville, Tennessee, United States, 37232-0011
      • Vanderbilt University Medical Center /ID# 216675
  • Texas
    • Cypress, Texas, United States, 77429
      • Houston Pulmonary Sleep and Allergy Associates /ID# 216942
    • Dallas, Texas, United States, 75231-4316
      • Kerwin Research Center /ID# 216587
    • Dallas, Texas, United States, 75243-1188
      • Neurology Consultants of Dallas - LBJ Fwy /ID# 216564
    • Georgetown, Texas, United States, 78628-4126
      • Texas Movement Disorder Specialists /ID# 216523
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital /ID# 216707
    • Round Rock, Texas, United States, 78681
      • Central Texas Neurology Consul /ID# 216629
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Health Care /ID# 216710
  • Virginia
    • Norfolk, Virginia, United States, 23502-3932
      • Meridian Clinical Research /ID# 216731
    • Richmond, Virginia, United States, 23229-4913
      • Neurological Associates - Forest Ave /ID# 216636
  • Washington
    • Seattle, Washington, United States, 98122-5788
      • Swedish Neuroscience /ID# 216526
    • Spokane, Washington, United States, 99202-1342
      • Inland Northwest Research /ID# 221036
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226-3522
      • Medical College of Wisconsin /ID# 216498

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa-responsive.
• Participant must be taking a minimum of 400 milligrams/day (mg/day) of Levodopa (LD) equivalents and be judged by the investigator to have motor symptoms inadequately controlled by current therapy, have a recognizable/identifiable "Off" and "On" states (motor fluctuations), and have an average "Off" time of at least 2.5 hours/day over 3 consecutive PD Diary days with a minimum of 2 hours each day.
• Participant or caregiver, if applicable, demonstrates the understanding and correct use of the delivery system, including the insertion of the cannula into the participant's abdomen, as assessed by the investigator or designee during the Screening period.

Exclusion Criteria:

• Clinically significant, unstable medical conditions or any other reason that the investigator determines would interfere with the participant's participation in this study or would make the participant an unsuitable candidate to receive study drug.
• History of allergic reaction or significant sensitivity to LD or constituents of the study drug (and its excipients) and/or other products in the same class.
• Participant has not received deep brain stimulation, CD/LD enteral suspension, or any other PD medication as continuous daily infusion, whether commercially available or investigational. Previous exposure to ABBV-951 is not allowed.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABBV-951 + Placebo for Levodopa/Carbidopa (LD/CD); After an open-label LD/CD Stabilization Period, participants will receive double-blind ABBV-951 by continuous subcutaneous infusion (CSCI) and oral placebo for LD/CD for 12 weeks	Drug: ABBV-951; Solution for continuous subcutaneous infusion (CSCI); Drug: Placebo for Levodopa/Carbidopa (LD/CD); Oral capsule
Active Comparator: Levodopa/Carbidopa (LD/CD) + Placebo for ABBV-951; After an open-label LD/CD Stabilization Period, participants will receive double-blind oral LD/CD and CSCI of placebo for ABBV-951 for 12 weeks	Drug: Levodopa/Carbidopa (LD/CD); Oral encapsulated tablet; Drug: Placebo for ABBV-951; Solution for continuous subcutaneous infusion (CSCI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Week 12 of the Double-Blind Treatment Period in Average Daily Normalized "On" Time Without Troublesome Dyskinesia	"On" time is defined as periods of good motor symptom control, and was assessed by the Parkinson's Disease (PD) diary. The normalized "On" time without troublesome dyskinesia is the sum of the normalized "On" time without dyskinesia and the normalized "On" time with non-troublesome dyskinesia. "On" time without dyskinesia plus "On" time with non-troublesome dyskinesia are based on the PD Diary (normalized to a 16-hour waking day averaged over 3 consecutive days). Baseline value is defined as the average of normalized "On" time without troublesome dyskinesia collected over the 3 PD Diary days before randomization.	Baseline (Week 0) up to Week 12 of the double-blind treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Week 12 of the Double-Blind Treatment Period in Average Daily Normalized "Off" Time (Hours)	"Off" time is defined as periods of poor mobility, tremor, slowness, and stiffness and was assessed by the PD Diary.	Baseline (Week 0) up to Week 12 of the double-blind treatment period
Change From Baseline to Week 12 of the Double-Blind Treatment Period in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score	The Part II MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of PD. MDS-UPDRS is multimodal scale assessing impairment and disability. Part II assesses the participant's motor experiences of daily living with 13 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part II scores range from 0 to 52, with higher scores indicating more severe symptoms of PD.	Baseline (Week 0) up to Week 12 of the double-blind treatment period
Early Morning "Off" Status (Morning Akinesia) at Week 12 of the Double-Blind Treatment Period	Early morning "Off" status is assessed by the PD Diary as percentage of participants with early morning "Off" upon waking up at Week 12, based on the first morning symptom upon awakening on the last valid PD Diary day at Week 12. "Off" time is defined as periods of poor mobility, tremor, slowness, and stiffness and was assessed by the PD Diary.	Week 12 of the double-blind treatment period
Change From Baseline to Week 12 of the Double-Blind Treatment Period in Average Daily Normalized "On" Time Without Dyskinesia (Hours)	"On" time is defined as periods of good motor symptom control, and was assessed by the PD diary. The normalized "On" time without dyskinesia is defined as the hours of average daily normalized "On" time without dyskinesia as assessed by the PD Diary (normalized to a 16-hour waking day averaged over 3 consecutive days). Baseline value is defined as the average of normalized "On" time without dyskinesia collected over the 3 PD Diary days before randomization.	Baseline, Week 12 of the double-blind treatment period
Change From Baseline to Week 12 of the Double-Blind Treatment Period in Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score	The PDSS-2 addresses PD-specific sleep disturbances such as restless leg syndrome (RLS), morning akinesia, pain, and sleep apnea. The frequency is assessed for the 15 sleep problems based on a 5-point Likert-type scale (ranging from 0 [never] to 4 [very often]). Scores are calculated for each of the 3 domains (motor symptoms at night, PD symptoms at night, and disturbed sleep) as well as a total score. The PDSS-2 domain scores range from 0 to 20 and the total score is a sum of the 3 domains and ranges from 0 to 60. Higher scores indicate higher frequency and more severe impact of PD on sleep.	Baseline (Week 0) up to Week 12 of the double-blind treatment period
Change From Baseline to Week 12 of the Double-Blind Treatment Period in Quality of Life Assessed by Parkinson's Disease Questionnaire 39 Item (PDQ-39) Summary Index Score	The 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. It evaluates the 8 dimensions of mobility, activities of daily living, emotional well-being, stigma, social support, cognition, and communication. Data from the PDQ-39 can be presented in either domain scores or as a summary index score. The full range of the PDQ-39 Summary Index score is from 0 (no patient-related symptoms/quality of life unaffected) to 100 (highest patient-related symptoms/low quality of life).	Baseline (Week 0) up to Week 12 of the double-blind treatment period
Change From Baseline to Week 12 of the Double-Blind Treatment Period in Quality of Life Assessed by the EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Summary Index	The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. The health status is converted to an index value using the country-specific weighted scoring algorithm for the United States (US). The summary index value for the US ranges from a worst score of -0.109 to a best score of 1. An increase in the EQ-5D-5L total score indicates improvement.	Baseline (Week 0) up to Week 12 of the double-blind treatment period
Change From Baseline to Week 12 of the Double-Blind Treatment Period in Median Bradykinesia Score (BK50) as Assessed by the Parkinson's KinetiGraph/Personal KinetiGraph (PKG) Wearable Device	The PKG wearable device is an innovative mobile health technology that provides continuous, objective, ambulatory assessment of the symptoms of PD including tremor, bradykinesia, dyskinesia, and daytime somnolence. For each participant, the PKG watch collected data continuously and an algorithm calculated a bradykinesia score every 2 minutes between 9am-6pm across multiple days. Among these scores for this participant at this visit, the median of all the score values is defined as BK50. A higher score indicates worse bradykinesia (there is no prespecified range of scores). The BK50 scores for all participants across all visits were then analyzed with mixed-effect model for repeated measures (MMRM) and the LS mean (model-based mean) was obtained from the model.	Baseline (Week 0) up to Week 12 of the double-blind treatment period
Change From Baseline to Week 12 of the Double-Blind Treatment Period in Interquartile Range of Bradykinesia Score (BK75-BK25) as Assessed by the PKG Wearable Device	The PKG wearable device is an innovative mobile health technology that provides continuous, objective, ambulatory assessment of the symptoms of PD including tremor, bradykinesia, dyskinesia, and daytime somnolence. For each participant, the PKG watch collected data continuously and an algorithm calculated a bradykinesia score every 2 minutes between 9am-6pm across multiple days. Among these scores for this participant at this visit, the median of all the score values is defined as BK50 (there is no prespecified range of scores). BK75-BK25 is the difference between the third quartile (BK75) and first quartile (BK25) bradykinesia scores, and this interquartile range is a measure of variability of bradykinesia. A higher score indicates a higher degree of variability in bradykinesia scores. The BK75 and BK 25 scores for all participants across all visits were then analyzed with mixed-effect model for repeated measures (MMRM) and the LS mean (model-based mean) was obtained from the model.	Baseline (Week 0) up to Week 12 of the double-blind treatment period
Change From Baseline to Week 12 of the Double-Blind Treatment Period in Median Dyskinesia Score (DK50) as Assessed by the PKG Wearable Device	The PKG wearable device is an innovative mobile health technology that provides continuous, objective, ambulatory assessment of the symptoms of PD including tremor, bradykinesia, dyskinesia, and daytime somnolence. For each participant, the PKG watch collected data continuously and an algorithm calculated a dyskinesia score every 2 minutes between 9am-6pm across multiple days. Among these scores for this participant at this visit, the median of all the score values is defined as DK50. A higher score indicates worse dyskinesia (there is no prespecified range of scores). The DK50 scores for all participants across all visits were then analyzed with mixed-effect model for repeated measures (MMRM) and the LS mean (model-based mean) was obtained from the model.	Baseline (Week 0) up to Week 12 of the double-blind treatment period
Change From Baseline to Week 12 of the Double-Blind Treatment Period in Interquartile Range of Dyskinesia Score (DK75-DK25) as Assessed by the PKG Wearable Device	The PKG wearable device is an innovative mobile health technology that provides continuous, objective, ambulatory assessment of the symptoms of PD including tremor, bradykinesia, dyskinesia, and daytime somnolence. For each participant, the PKG watch collected data continuously and an algorithm calculated a dyskinesia score every 2 minutes between 9am-6pm across multiple days. Among these scores for this participant at this visit, the median of all the score values is defined as DK50 (there is no prespecified range of scores). DK75-DK25 is the difference between the third quartile (DK75) and first quartile (DK25) dyskinesia scores, and this interquartile range is a measure of variability of dyskinesia. A higher score indicates a higher degree of variability in dyskinesia scores. The DK75 and DK25 scores for all participants across all visits were then analyzed with mixed-effect model for repeated measures (MMRM) and the LS mean (model-based mean) was obtained from the model.	Baseline (Week 0) up to Week 12 of the double-blind treatment period
Number of Participants With Irritation Grade Numeric Grade >= 5 or Letter Grade >= D on the Infusion Site Irritation Scale Across All Study Post-Baseline Visits	The investigator or qualified designee evaluated the infusion site area (abdomen). A 2-part (numeric and letter grading) evaluation scale was used to assess irritation. Irritation - Numeric Grades: 0 = No evidence of irritation; 1 = Minimal erythema, barely perceptible; 2 = Moderate erythema, readily visible; or minimal edema, or minimal papular response; 3 = Erythema and papules; 4 = Definite edema; 5 = Erythema, edema, and papules; 6 = Vesicular eruption; 7 = Strong reaction spreading beyond the test site. Irritation - Letter Grades: A = No finding; B = Slight glazed appearance; C = Marked glazing; D = Glazing with peeling and cracking; E = Glazing with fissures; F = Film of dried serous exudates covering all or portion of the patch site; G = Small petechial erosions and/or scabs.	Day 2 up to Week 12 of the double-blind treatment period plus 30 days
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the Oral LD/CD Stabilization Period	An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. An AE, whether associated with study drug or not, meeting any of the following criteria is considered a serious AE (SAE): results in death; is life-threatening; results in hospitalization or prolongation of hospitalization; is a congenital anomaly; results in persistent or significant disability/incapacity; is an important medical event requiring medical or surgical intervention to prevent a serious outcome. The severity of each AE is rated as mild, moderate, or severe, and having either a reasonable possibility or no reasonable possibility of relationship to study drug. Events were considered treatment emergent if they arose after the first dose of study drug.	From first dose of stabilization period treatment up to the first dose of the double-blind treatment period
Number of Participants With TEAEs During the Double-Blind Treatment Period	An AE is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. An AE, whether associated with study drug or not, meeting any of the following criteria is considered an SAE: results in death; is life-threatening; results in hospitalization or prolongation of hospitalization; is a congenital anomaly; results in persistent or significant disability/incapacity; is an important medical event requiring medical or surgical intervention to prevent a serious outcome. The severity of each AE is rated as mild, moderate, or severe, and having either a reasonable possibility or no reasonable possibility of relationship to study drug. Adverse events of special interest include polyneuropathy, weight loss, somnolence, hallucinations/psychosis. Events were considered treatment emergent if they arose after the first dose of study drug.	From first dose of double-blind treatment up to Week 12 of the double-blind treatment period plus 30 days
Number of Participants With Potentially Clinically Significant Changes From Baseline in Hematology, Chemistry, Urinalysis, Special Laboratory Parameters, Vital Signs, and Electrocardiograms (ECGs)	Measures analyzed for prespecified potentially clinically significant criteria: hematology (hematocrit, hemoglobin, red blood cells, white blood cells, neutrophils, bands, lymphocytes, monocytes, basophils, eosinophils, platelets, mean corpuscular hemoglobin, mean corpuscular volume concentration, prothrombin time, activated partial thromboplastin time), laboratory (blood urea nitrogen, creatinine, creatine phosphokinase, bilirubin, alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, gamma-glutamyl transpeptidase, alkaline phosphatase, sodium, potassium, calcium, phosphorus, uric acid, total protein, albumin, glucose, sodium bicarbonate, chloride, triglycerides, cholesterol, magnesium), special lab criteria (vitamin B12, vitamin B6, folate, homocysteine, methylmalonic acid), vital signs (diastolic and systolic blood pressure, pulse rate), ECG (heart rate, PR, and QTcF interval), urinalysis (specific gravity, ketones, pH, protein, glucose, blood, bilirubin).	Screening up to Week 12 of the double-blind treatment period
Number of Participants With Affirmative Responses on the Columbia-Suicide Severity Rating Scale (C-SSRS) Across All Study Post-Baseline Visits During the Double-Blind Treatment Period	The C-SSRS is a systematically administered instrument developed to track suicidal adverse events across a treatment study. The instrument is designed to assess suicidal behavior and ideation, track and assess all suicidal events, as well as the lethality of attempts. Suicidal ideation categories include the following: wish to be dead; nonspecific active suicidal thoughts; active suicidal ideation without intent to act; active suicidal ideation with some intent to act but no plan; active suicidal ideation with plan and intent. Suicidal behavior categories include the following: actual attempt; interrupted attempt; aborted attempt; preparatory acts or behavior; suicidal behavior; completed suicide.	Screening up to Week 12 of the double-blind treatment period
Number of Participants With a Subscore > 5 For Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Ration Scale (QUIP-RS) at Any Time During the Double-Blind Treatment Period	The QUIP-RS measures the severity of symptoms and support a diagnosis of impulse control disorders and related disorders in PD. QUIP-RS subscores include gambling (score 0 to 16), sex (score 0 to 16), buying (score 0 to 16), eating (score 0 to 16), hobbyism-punding (score 0 to 32), and PD medication use (score 0 to 16). Higher scores represent a worse outcome.	Baseline (Week 0) up to Week 12 of the double-blind treatment period

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

General Publications

• Soileau MJ, Aldred J, Budur K, Fisseha N, Fung VS, Jeong A, Kimber TE, Klos K, Litvan I, O'Neill D, Robieson WZ, Spindler MA, Standaert DG, Talapala S, Vaou EO, Zheng H, Facheris MF, Hauser RA. Safety and efficacy of continuous subcutaneous foslevodopa-foscarbidopa in patients with advanced Parkinson's disease: a randomised, double-blind, active-controlled, phase 3 trial. Lancet Neurol. 2022 Dec;21(12):1099-1109. doi: 10.1016/S1474-4422(22)00400-8.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2020
• Primary Completion (Actual): September 29, 2021
• Study Completion (Actual): September 29, 2021

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (Actual): May 8, 2020

Study Record Updates

• Last Update Posted (Actual): November 18, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: ABBV-951; Levodopa/Carbidopa (LD/CD); Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP); Parkinson's Disease (PD)
• 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; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Aromatic Amino Acid Decarboxylase Inhibitors; Levodopa; Carbidopa
• Other Study ID Numbers: M15-736; 2019-003930-18 (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 and 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, please refer to the link below.
• 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 (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (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