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

• ClinicalTrials.gov Identifier: NCT04380142
• Recruitment Status: Completed
• First Posted: May 8, 2020
• Results First Posted: November 18, 2022
• Last Update Posted: November 18, 2022
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Study Description

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 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.

Condition or disease	Intervention/treatment	Phase
Parkinson's Disease (PD)	Drug: ABBV-951; Drug: Placebo for Levodopa/Carbidopa (LD/CD); Drug: Levodopa/Carbidopa (LD/CD); Drug: Placebo for ABBV-951	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 174 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: October 19, 2020
• Actual Primary Completion Date: September 29, 2021
• Actual Study Completion Date: September 29, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline to Week 12 of the Double-Blind Treatment Period in Average Daily Normalized "On" Time Without Troublesome Dyskinesia [ Time Frame: Baseline (Week 0) up to Week 12 of the double-blind treatment period ]
   "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.

Secondary Outcome Measures :

1. Change From Baseline to Week 12 of the Double-Blind Treatment Period in Average Daily Normalized "Off" Time (Hours) [ Time Frame: Baseline (Week 0) up to Week 12 of the double-blind treatment period ]
   "Off" time is defined as periods of poor mobility, tremor, slowness, and stiffness and was assessed by the PD Diary.
2. 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 [ Time Frame: Baseline (Week 0) up to Week 12 of the double-blind treatment period ]
   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.
3. Early Morning "Off" Status (Morning Akinesia) at Week 12 of the Double-Blind Treatment Period [ Time Frame: 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.

4. Change From Baseline to Week 12 of the Double-Blind Treatment Period in Average Daily Normalized "On" Time Without Dyskinesia (Hours) [ Time Frame: Baseline, Week 12 of the double-blind treatment period ]

   "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.

5. Change From Baseline to Week 12 of the Double-Blind Treatment Period in Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score [ Time Frame: Baseline (Week 0) up to Week 12 of the double-blind treatment period ]
   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.
6. 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 [ Time Frame: Baseline (Week 0) up to Week 12 of the double-blind treatment period ]
   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).
7. 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 [ Time Frame: Baseline (Week 0) up to Week 12 of the double-blind treatment period ]
   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.
8. 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 [ Time Frame: Baseline (Week 0) up to Week 12 of the double-blind treatment period ]
   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.
9. 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 [ Time Frame: Baseline (Week 0) up to Week 12 of the double-blind treatment period ]
   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.
10. Change From Baseline to Week 12 of the Double-Blind Treatment Period in Median Dyskinesia Score (DK50) as Assessed by the PKG Wearable Device [ Time Frame: Baseline (Week 0) up to Week 12 of the double-blind treatment period ]
    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.
11. 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 [ Time Frame: Baseline (Week 0) up to Week 12 of the double-blind treatment period ]
    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.
12. 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 [ Time Frame: Day 2 up to Week 12 of the double-blind treatment period plus 30 days ]
    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.
13. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the Oral LD/CD Stabilization Period [ Time Frame: From first dose of stabilization period treatment up to the first dose of the double-blind treatment 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.
14. Number of Participants With TEAEs During the Double-Blind Treatment Period [ Time Frame: From first dose of double-blind treatment up to Week 12 of the double-blind treatment period plus 30 days ]
    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.
15. Number of Participants With Potentially Clinically Significant Changes From Baseline in Hematology, Chemistry, Urinalysis, Special Laboratory Parameters, Vital Signs, and Electrocardiograms (ECGs) [ Time Frame: Screening up to Week 12 of the double-blind treatment period ]
    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).
16. 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 [ Time Frame: Screening up to Week 12 of 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.
17. 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 [ Time Frame: Baseline (Week 0) up to Week 12 of 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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Alabama

University of Alabama at Birmingham - Main /ID# 216595

Birmingham, Alabama, United States, 35233

University of South Alabama /ID# 216757

Mobile, Alabama, United States, 36604-3302

United States, Arizona

Xenoscience, Inc /ID# 217110

Phoenix, Arizona, United States, 85004

Barrow Neurological Institute /ID# 216566

Phoenix, Arizona, United States, 85013-4407

HonorHealth /ID# 216642

Phoenix, Arizona, United States, 85018-2111

Movement Disorders Center of Arizona /ID# 216503

Scottsdale, Arizona, United States, 85258-4582

Banner Sun Health Res Inst /ID# 216507

Sun City, Arizona, United States, 85351

United States, Arkansas

University of Arkansas for Medical Sciences /ID# 216501

Little Rock, Arkansas, United States, 72205

United States, California

The Parkinson's & Movement Disorder Institute - Fountain Valley /ID# 216705

Fountain Valley, California, United States, 92708

Neuro Pain Medical Center /ID# 216551

Fresno, California, United States, 93710-5473

University of California, San /ID# 216598

La Jolla, California, United States, 92093

Loma Linda University Medical /ID# 216500

Loma Linda, California, United States, 92354

Collaborative Neuroscience Research - Long Beach /ID# 216970

Long Beach, California, United States, 90806

University of California, Los Angeles /ID# 216674

Los Angeles, California, United States, 90095

SC3 Research Group - Pasadena /ID# 216821

Pasadena, California, United States, 91105-3149

Cedars-Sinai Medical Center-West Hollywood /ID# 216561

West Hollywood, California, United States, 90048

United States, Colorado

University of Colorado Hospital /ID# 216527

Aurora, Colorado, United States, 80045

Alpine Clinical Research Center /ID# 216637

Boulder, Colorado, United States, 80301-1880

Denver Neurological Research, LLC /ID# 216784

Denver, Colorado, United States, 80210-7009

Rocky Mountain Movement Disorders Center /ID# 216737

Englewood, Colorado, United States, 80113-2736

United States, Delaware

Christiana Care Health Service /ID# 216515

Newark, Delaware, United States, 19713

United States, District of Columbia

Georgetown University Hospital /ID# 216632

Washington, District of Columbia, United States, 20007

United States, Florida

Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 216517

Boca Raton, Florida, United States, 33486

Brain Matters Research /ID# 217089

Delray Beach, Florida, United States, 33445

Fixel Institute for Neurological Diseases /ID# 216514

Gainesville, Florida, United States, 32608-3928

Visionary Investigators Network - Miami /ID# 216679

Miami, Florida, United States, 33176-2148

Renstar Medical Research /ID# 216765

Ocala, Florida, United States, 34470

Neurology Associates Ormond Beach /ID# 216521

Ormond Beach, Florida, United States, 32174

Parkinson's Disease Treatment Center of Southwest Florida /ID# 222656

Port Charlotte, Florida, United States, 33980

University of South Florida /ID# 216638

Tampa, Florida, United States, 33612

Premiere Research Institute - Palm Beach /ID# 217207

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

United States, Georgia

Duplicate_Atlanta Center for Medical Res /ID# 217091

Atlanta, Georgia, United States, 30331

The Neurological Center of North Georgia /ID# 216499

Gainesville, Georgia, United States, 30501

United States, Illinois

Rush University Medical Center /ID# 216567

Chicago, Illinois, United States, 60612

University of Chicago Medical /ID# 217187

Chicago, Illinois, United States, 60637

United States, Indiana

Indiana Clinical Research Cent /ID# 216615

Indianapolis, Indiana, United States, 46202

United States, Kansas

Univ Kansas Med Ctr /ID# 216528

Kansas City, Kansas, United States, 66160

United States, Massachusetts

St Elizabeth's Medical Center - Brighton /ID# 216716

Brighton, Massachusetts, United States, 02135-2907

United States, Michigan

Michigan State University /ID# 217158

East Lansing, Michigan, United States, 48824

United States, Missouri

Clinical Research Professionals - Chesterfield /ID# 216669

Chesterfield, Missouri, United States, 63005-1205

St. Luke's Hosp. of Kansas City /ID# 216633

Kansas City, Missouri, United States, 64111

Washington University-School of Medicine /ID# 216548

Saint Louis, Missouri, United States, 63110

United States, New Jersey

Global Neurosciences Institute /ID# 217875

Lawrenceville, New Jersey, United States, 08648-2300

United States, New York

Northwell Health /ID# 216833

Lake Success, New York, United States, 11042

Mount Sinai Beth Israel /ID# 216712

New York, New York, United States, 10003

University of Rochester /ID# 218737

Rochester, New York, United States, 14642-0001

United States, North Carolina

Wake Forest Univ HS /ID# 216522

Winston-Salem, North Carolina, United States, 27157

United States, Ohio

Ohio State University - Wexner Medical Center /ID# 216900

Columbus, Ohio, United States, 43210-1229

The Orthopedic Foundation /ID# 217157

New Albany, Ohio, United States, 43054-8167

United States, Oklahoma

The Movement Disorder Clinic of Oklahoma /ID# 216860

Tulsa, Oklahoma, United States, 74136-6378

United States, Oregon

Legacy Research Institute /ID# 216558

Portland, Oregon, United States, 97232-2003

United States, Pennsylvania

University of Pennsylvania /ID# 216560

Philadelphia, Pennsylvania, United States, 19104-5502

Thomas Jefferson University Hospital /ID# 216553

Philadelphia, Pennsylvania, United States, 19107

United States, South Carolina

Prisma Health-Upstate /ID# 216594

Greenville, South Carolina, United States, 29615

Premier Neurology, P.C. /ID# 217308

Greer, South Carolina, United States, 29650

Coastal Neurology /ID# 217190

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

United States, Tennessee

KCA Neurology - Franklin /ID# 217419

Franklin, Tennessee, United States, 37067-5914

Vanderbilt University Medical Center /ID# 216675

Nashville, Tennessee, United States, 37232-0011

United States, Texas

Houston Pulmonary Sleep and Allergy Associates /ID# 216942

Cypress, Texas, United States, 77429

Kerwin Research Center /ID# 216587

Dallas, Texas, United States, 75231-4316

Neurology Consultants of Dallas - LBJ Fwy /ID# 216564

Dallas, Texas, United States, 75243-1188

Texas Movement Disorder Specialists /ID# 216523

Georgetown, Texas, United States, 78628-4126

Houston Methodist Hospital /ID# 216707

Houston, Texas, United States, 77030

Central Texas Neurology Consul /ID# 216629

Round Rock, Texas, United States, 78681

United States, Utah

University of Utah Health Care /ID# 216710

Salt Lake City, Utah, United States, 84132

United States, Virginia

Meridian Clinical Research /ID# 216731

Norfolk, Virginia, United States, 23502-3932

Neurological Associates - Forest Ave /ID# 216636

Richmond, Virginia, United States, 23229-4913

United States, Washington

Swedish Neuroscience /ID# 216526

Seattle, Washington, United States, 98122-5788

Inland Northwest Research /ID# 221036

Spokane, Washington, United States, 99202-1342

United States, Wisconsin

Medical College of Wisconsin /ID# 216498

Milwaukee, Wisconsin, United States, 53226-3522

Australia, New South Wales

Liverpool Hospital /ID# 218681

Liverpool, New South Wales, Australia, 2170

Westmead Hospital /ID# 216535

Westmead, New South Wales, Australia, 2145

Australia, Queensland

Gold coast University Hospital /ID# 218373

SouthPort, Queensland, Australia, 4215

Australia, South Australia

Royal Adelaide Hospital /ID# 216533

Adelaide, South Australia, Australia, 5000

Australia, Victoria

Kingston Centre /ID# 216537

Cheltenham, Victoria, Australia, 3192

The Royal Melbourne Hospital /ID# 216536

Parkville, Victoria, Australia, 3050

Sponsors and Collaborators

AbbVie

Investigators

• Study Director: ABBVIE INC.; AbbVie

  Study Documents (Full-Text)

Documents provided by AbbVie:

Study Protocol  [PDF] September 10, 2021

Statistical Analysis Plan  [PDF] October 19, 2021

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Erratum In: Lancet Neurol. 2023 Mar;22(3):e5.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT04380142
• Other Study ID Numbers: M15-736; 2019-003930-18 ( EudraCT Number )
• First Posted: May 8, 2020
• Results First Posted: November 18, 2022
• Last Update Posted: November 18, 2022
• Last Verified: October 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)
• Time Frame: For details on when studies are available for sharing, please refer to the link below.
• 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.
• URL: https://vivli.org/ourmember/abbvie/

• 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

Keywords provided by AbbVie:

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

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Levodopa; Carbidopa; Antiparkinson Agents; Anti-Dyskinesia Agents; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Aromatic Amino Acid Decarboxylase Inhibitors; Enzyme Inhibitors