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

NCT04380142 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: M15-7362019-003930-18
• Study Type: interventional
• Target: 174
• Locations: 2 countries
• Sites: 76

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.

Conditions

Parkinson's Disease (PD)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Change From Baseline to Week 12 of the Double-Blind Treatment Period in Average Daily Normalized "Off" Time (Hours)

  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

  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

  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)

  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

  Baseline (Week 0) up to Week 12 of the double-blind treatment period

Study Arms (2)

ABBV-951 + Placebo for Levodopa/Carbidopa (LD/CD)

EXPERIMENTAL

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; Drug: Placebo for Levodopa/Carbidopa (LD/CD)

Levodopa/Carbidopa (LD/CD) + Placebo for ABBV-951

ACTIVE COMPARATOR

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); Drug: Placebo for ABBV-951

Interventions

ABBV-951 DRUG

Solution for continuous subcutaneous infusion (CSCI)

ABBV-951 + Placebo for Levodopa/Carbidopa (LD/CD)

Placebo for Levodopa/Carbidopa (LD/CD) DRUG

Oral capsule

ABBV-951 + Placebo for Levodopa/Carbidopa (LD/CD)

Levodopa/Carbidopa (LD/CD) DRUG

Oral encapsulated tablet

Levodopa/Carbidopa (LD/CD) + Placebo for ABBV-951

Placebo for ABBV-951 DRUG

Solution for continuous subcutaneous infusion (CSCI)

Levodopa/Carbidopa (LD/CD) + Placebo for ABBV-951

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (76)

University of Alabama at Birmingham - Main /ID# 216595

Birmingham, Alabama, 35233, United States

Location

University of South Alabama /ID# 216757

Mobile, Alabama, 36604-3302, United States

Location

Xenoscience, Inc /ID# 217110

Phoenix, Arizona, 85004, United States

Location

Barrow Neurological Institute /ID# 216566

Phoenix, Arizona, 85013-4407, United States

Location

HonorHealth /ID# 216642

Phoenix, Arizona, 85018-2111, United States

Location

Movement Disorders Center of Arizona /ID# 216503

Scottsdale, Arizona, 85258-4582, United States

Location

Banner Sun Health Res Inst /ID# 216507

Sun City, Arizona, 85351, United States

Location

University of Arkansas for Medical Sciences /ID# 216501

Little Rock, Arkansas, 72205, United States

Location

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

Fountain Valley, California, 92708, United States

Location

Neuro Pain Medical Center /ID# 216551

Fresno, California, 93710-5473, United States

Location

University of California, San /ID# 216598

La Jolla, California, 92093, United States

Location

Loma Linda University Medical /ID# 216500

Loma Linda, California, 92354, United States

Location

Collaborative Neuroscience Research - Long Beach /ID# 216970

Long Beach, California, 90806, United States

Location

University of California, Los Angeles /ID# 216674

Los Angeles, California, 90095, United States

Location

SC3 Research Group - Pasadena /ID# 216821

Pasadena, California, 91105-3149, United States

Location

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

West Hollywood, California, 90048, United States

Location

University of Colorado Hospital /ID# 216527

Aurora, Colorado, 80045, United States

Location

Alpine Clinical Research Center /ID# 216637

Boulder, Colorado, 80301-1880, United States

Location

Denver Neurological Research, LLC /ID# 216784

Denver, Colorado, 80210-7009, United States

Location

Rocky Mountain Movement Disorders Center /ID# 216737

Englewood, Colorado, 80113-2736, United States

Location

Christiana Care Health Service /ID# 216515

Newark, Delaware, 19713, United States

Location

Georgetown University Hospital /ID# 216632

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

Location

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

Boca Raton, Florida, 33486, United States

Location

Brain Matters Research /ID# 217089

Delray Beach, Florida, 33445, United States

Location

Fixel Institute for Neurological Diseases /ID# 216514

Gainesville, Florida, 32608-3928, United States

Location

Visionary Investigators Network - Miami /ID# 216679

Miami, Florida, 33176-2148, United States

Location

Renstar Medical Research /ID# 216765

Ocala, Florida, 34470, United States

Location

Neurology Associates Ormond Beach /ID# 216521

Ormond Beach, Florida, 32174, United States

Location

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

Port Charlotte, Florida, 33980, United States

Location

University of South Florida /ID# 216638

Tampa, Florida, 33612, United States

Location

Premiere Research Institute - Palm Beach /ID# 217207

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

Location

Duplicate_Atlanta Center for Medical Res /ID# 217091

Atlanta, Georgia, 30331, United States

Location

The Neurological Center of North Georgia /ID# 216499

Gainesville, Georgia, 30501, United States

Location

Rush University Medical Center /ID# 216567

Chicago, Illinois, 60612, United States

Location

University of Chicago Medical /ID# 217187

Chicago, Illinois, 60637, United States

Location

Indiana Clinical Research Cent /ID# 216615

Indianapolis, Indiana, 46202, United States

Location

Univ Kansas Med Ctr /ID# 216528

Kansas City, Kansas, 66160, United States

Location

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

Brighton, Massachusetts, 02135-2907, United States

Location

Michigan State University /ID# 217158

East Lansing, Michigan, 48824, United States

Location

Clinical Research Professionals - Chesterfield /ID# 216669

Chesterfield, Missouri, 63005-1205, United States

Location

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

Kansas City, Missouri, 64111, United States

Location

Washington University-School of Medicine /ID# 216548

St Louis, Missouri, 63110, United States

Location

Global Neurosciences Institute /ID# 217875

Lawrenceville, New Jersey, 08648-2300, United States

Location

Northwell Health /ID# 216833

Lake Success, New York, 11042, United States

Location

Mount Sinai Beth Israel /ID# 216712

New York, New York, 10003, United States

Location

University of Rochester /ID# 218737

Rochester, New York, 14642-0001, United States

Location

Wake Forest Univ HS /ID# 216522

Winston-Salem, North Carolina, 27157, United States

Location

Ohio State University - Wexner Medical Center /ID# 216900

Columbus, Ohio, 43210-1229, United States

Location

The Orthopedic Foundation /ID# 217157

New Albany, Ohio, 43054-8167, United States

Location

The Movement Disorder Clinic of Oklahoma /ID# 216860

Tulsa, Oklahoma, 74136-6378, United States

Location

Legacy Research Institute /ID# 216558

Portland, Oregon, 97232-2003, United States

Location

University of Pennsylvania /ID# 216560

Philadelphia, Pennsylvania, 19104-5502, United States

Location

Thomas Jefferson University Hospital /ID# 216553

Philadelphia, Pennsylvania, 19107, United States

Location

Prisma Health-Upstate /ID# 216594

Greenville, South Carolina, 29615, United States

Location

Premier Neurology, P.C. /ID# 217308

Greer, South Carolina, 29650, United States

Location

Coastal Neurology /ID# 217190

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

Location

KCA Neurology - Franklin /ID# 217419

Franklin, Tennessee, 37067-5914, United States

Location

Vanderbilt University Medical Center /ID# 216675

Nashville, Tennessee, 37232-0011, United States

Location

Houston Pulmonary Sleep and Allergy Associates /ID# 216942

Cypress, Texas, 77429, United States

Location

Kerwin Research Center /ID# 216587

Dallas, Texas, 75231-4316, United States

Location

Neurology Consultants of Dallas - LBJ Fwy /ID# 216564

Dallas, Texas, 75243-1188, United States

Location

Texas Movement Disorder Specialists /ID# 216523

Georgetown, Texas, 78628-4126, United States

Location

Houston Methodist Hospital /ID# 216707

Houston, Texas, 77030, United States

Location

Central Texas Neurology Consul /ID# 216629

Round Rock, Texas, 78681, United States

Location

University of Utah Health Care /ID# 216710

Salt Lake City, Utah, 84132, United States

Location

Meridian Clinical Research /ID# 216731

Norfolk, Virginia, 23502-3932, United States

Location

Neurological Associates - Forest Ave /ID# 216636

Richmond, Virginia, 23229-4913, United States

Location

Swedish Neuroscience /ID# 216526

Seattle, Washington, 98122-5788, United States

Location

Inland Northwest Research /ID# 221036

Spokane, Washington, 99202-1342, United States

Location

Medical College of Wisconsin /ID# 216498

Milwaukee, Wisconsin, 53226-3522, United States

Location

Liverpool Hospital /ID# 218681

Liverpool, New South Wales, 2170, Australia

Location

Westmead Hospital /ID# 216535

Westmead, New South Wales, 2145, Australia

Location

Gold coast University Hospital /ID# 218373

Southport, Queensland, 4215, Australia

Location

Royal Adelaide Hospital /ID# 216533

Adelaide, South Australia, 5000, Australia

Location

Kingston Centre /ID# 216537

Cheltenham, Victoria, 3192, Australia

Location

The Royal Melbourne Hospital /ID# 216536

Parkville, Victoria, 3050, Australia

Location

Related Publications (3)

• Antonini A, Bergmans B, Kern DS, Gandor F, Nishikawa N, Standaert DG, Fritz B, Gupta R, Nozaki T, Shah MB, Bergmann L, Kimber T. Foslevodopa/Foscarbidopa in Younger Patients Earlier Within Advanced Parkinson's Disease: Post Hoc Analysis of a Randomized Trial. Neurol Ther. 2026 Feb;15(1):309-324. doi: 10.1007/s40120-025-00856-1. Epub 2025 Dec 1.

  PMID: 41324738 DERIVED

• Pahwa R, Aldred J, Soileau MJ, Standaert DG, Fung VSC, Kimber T, Malaty IA, Santos-Garcia D, Carroll C, Henriksen T, Parab A, Yan CH, Facheris MF, Spiegel A, Harmer L, Zamudio J, Chaudhuri KR. Improvement in Motor Consistency and Stability with Foslevodopa/Foscarbidopa in Advanced Parkinson's Disease: Post Hoc Analysis of Two Phase 3 Clinical Trials. Neurol Ther. 2025 Dec;14(6):2491-2506. doi: 10.1007/s40120-025-00827-6. Epub 2025 Oct 4.

  PMID: 41045349 DERIVED

• 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.

  PMID: 36402160 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Levodopa; Carbidopa; carbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine; Methyldopa; Hydrazines

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

1-800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 8, 2020
• Study Start: October 19, 2020
• Primary Completion: September 29, 2021
• Study Completion: September 29, 2021
• Last Updated: November 18, 2022
• Results First Posted: November 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

AU (6); US (70)