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
NCT ID: NCT04380142
Last Updated: 2022-11-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
174 participants
INTERVENTIONAL
2020-10-19
2021-09-29
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
ABBV-951
Solution for continuous subcutaneous infusion (CSCI)
Placebo for Levodopa/Carbidopa (LD/CD)
Oral capsule
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
Levodopa/Carbidopa (LD/CD)
Oral encapsulated tablet
Placebo for ABBV-951
Solution for continuous subcutaneous infusion (CSCI)
Interventions
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ABBV-951
Solution for continuous subcutaneous infusion (CSCI)
Placebo for Levodopa/Carbidopa (LD/CD)
Oral capsule
Levodopa/Carbidopa (LD/CD)
Oral encapsulated tablet
Placebo for ABBV-951
Solution for continuous subcutaneous infusion (CSCI)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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University of Alabama at Birmingham - Main /ID# 216595
Birmingham, Alabama, United States
University of South Alabama /ID# 216757
Mobile, Alabama, United States
Xenoscience, Inc /ID# 217110
Phoenix, Arizona, United States
Barrow Neurological Institute /ID# 216566
Phoenix, Arizona, United States
HonorHealth /ID# 216642
Phoenix, Arizona, United States
Movement Disorders Center of Arizona /ID# 216503
Scottsdale, Arizona, United States
Banner Sun Health Res Inst /ID# 216507
Sun City, Arizona, United States
University of Arkansas for Medical Sciences /ID# 216501
Little Rock, Arkansas, United States
The Parkinson's & Movement Disorder Institute - Fountain Valley /ID# 216705
Fountain Valley, California, United States
Neuro Pain Medical Center /ID# 216551
Fresno, California, United States
University of California, San /ID# 216598
La Jolla, California, United States
Loma Linda University Medical /ID# 216500
Loma Linda, California, United States
Collaborative Neuroscience Research - Long Beach /ID# 216970
Long Beach, California, United States
University of California, Los Angeles /ID# 216674
Los Angeles, California, United States
SC3 Research Group - Pasadena /ID# 216821
Pasadena, California, United States
Cedars-Sinai Medical Center-West Hollywood /ID# 216561
West Hollywood, California, United States
University of Colorado Hospital /ID# 216527
Aurora, Colorado, United States
Alpine Clinical Research Center /ID# 216637
Boulder, Colorado, United States
Denver Neurological Research, LLC /ID# 216784
Denver, Colorado, United States
Rocky Mountain Movement Disorders Center /ID# 216737
Englewood, Colorado, United States
Christiana Care Health Service /ID# 216515
Newark, Delaware, United States
Georgetown University Hospital /ID# 216632
Washington D.C., District of Columbia, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 216517
Boca Raton, Florida, United States
Brain Matters Research /ID# 217089
Delray Beach, Florida, United States
Fixel Institute for Neurological Diseases /ID# 216514
Gainesville, Florida, United States
Visionary Investigators Network - Miami /ID# 216679
Miami, Florida, United States
Renstar Medical Research /ID# 216765
Ocala, Florida, United States
Neurology Associates Ormond Beach /ID# 216521
Ormond Beach, Florida, United States
Parkinson's Disease Treatment Center of Southwest Florida /ID# 222656
Port Charlotte, Florida, United States
University of South Florida /ID# 216638
Tampa, Florida, United States
Premiere Research Institute - Palm Beach /ID# 217207
West Palm Beach, Florida, United States
Duplicate_Atlanta Center for Medical Res /ID# 217091
Atlanta, Georgia, United States
The Neurological Center of North Georgia /ID# 216499
Gainesville, Georgia, United States
Rush University Medical Center /ID# 216567
Chicago, Illinois, United States
University of Chicago Medical /ID# 217187
Chicago, Illinois, United States
Indiana Clinical Research Cent /ID# 216615
Indianapolis, Indiana, United States
Univ Kansas Med Ctr /ID# 216528
Kansas City, Kansas, United States
St Elizabeth's Medical Center - Brighton /ID# 216716
Brighton, Massachusetts, United States
Michigan State University /ID# 217158
East Lansing, Michigan, United States
Clinical Research Professionals - Chesterfield /ID# 216669
Chesterfield, Missouri, United States
St. Luke's Hosp. of Kansas City /ID# 216633
Kansas City, Missouri, United States
Washington University-School of Medicine /ID# 216548
St Louis, Missouri, United States
Global Neurosciences Institute /ID# 217875
Lawrenceville, New Jersey, United States
Northwell Health /ID# 216833
Lake Success, New York, United States
Mount Sinai Beth Israel /ID# 216712
New York, New York, United States
University of Rochester /ID# 218737
Rochester, New York, United States
Wake Forest Univ HS /ID# 216522
Winston-Salem, North Carolina, United States
Ohio State University - Wexner Medical Center /ID# 216900
Columbus, Ohio, United States
The Orthopedic Foundation /ID# 217157
New Albany, Ohio, United States
The Movement Disorder Clinic of Oklahoma /ID# 216860
Tulsa, Oklahoma, United States
Legacy Research Institute /ID# 216558
Portland, Oregon, United States
University of Pennsylvania /ID# 216560
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital /ID# 216553
Philadelphia, Pennsylvania, United States
Prisma Health-Upstate /ID# 216594
Greenville, South Carolina, United States
Premier Neurology, P.C. /ID# 217308
Greer, South Carolina, United States
Coastal Neurology /ID# 217190
Port Royal, South Carolina, United States
KCA Neurology - Franklin /ID# 217419
Franklin, Tennessee, United States
Vanderbilt University Medical Center /ID# 216675
Nashville, Tennessee, United States
Houston Pulmonary Sleep and Allergy Associates /ID# 216942
Cypress, Texas, United States
Kerwin Research Center /ID# 216587
Dallas, Texas, United States
Neurology Consultants of Dallas - LBJ Fwy /ID# 216564
Dallas, Texas, United States
Texas Movement Disorder Specialists /ID# 216523
Georgetown, Texas, United States
Houston Methodist Hospital /ID# 216707
Houston, Texas, United States
Central Texas Neurology Consul /ID# 216629
Round Rock, Texas, United States
University of Utah Health Care /ID# 216710
Salt Lake City, Utah, United States
Meridian Clinical Research /ID# 216731
Norfolk, Virginia, United States
Neurological Associates - Forest Ave /ID# 216636
Richmond, Virginia, United States
Swedish Neuroscience /ID# 216526
Seattle, Washington, United States
Inland Northwest Research /ID# 221036
Spokane, Washington, United States
Medical College of Wisconsin /ID# 216498
Milwaukee, Wisconsin, United States
Liverpool Hospital /ID# 218681
Liverpool, New South Wales, Australia
Westmead Hospital /ID# 216535
Westmead, New South Wales, Australia
Gold coast University Hospital /ID# 218373
Southport, Queensland, Australia
Royal Adelaide Hospital /ID# 216533
Adelaide, South Australia, Australia
Kingston Centre /ID# 216537
Cheltenham, Victoria, Australia
The Royal Melbourne Hospital /ID# 216536
Parkville, Victoria, Australia
Countries
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References
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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 Oct 4. doi: 10.1007/s40120-025-00827-6. Online ahead of print.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-003930-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M15-736
Identifier Type: -
Identifier Source: org_study_id
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