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
Public ClinicalTrials.gov record NCT04380142. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT04380142
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 174 participants
Conditions and interventions
Conditions
Interventions
- ABBV-951 Drug
- Placebo for Levodopa/Carbidopa (LD/CD) Drug
- Levodopa/Carbidopa (LD/CD) Drug
- Placebo for ABBV-951 Drug
Drug
Eligibility (public fields only)
- Age range
- 30 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 19, 2020 (Actual)
- Primary completion
- Sep 29, 2021 (Actual)
- Completion
- Sep 29, 2021 (Actual)
- Last update posted
- Nov 18, 2022
2020 – 2021
United States locations
- U.S. sites
- 70
- U.S. states
- 29
- U.S. cities
- 65
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham - Main /ID# 216595 | Birmingham | Alabama | 35233 | — |
| University of South Alabama /ID# 216757 | Mobile | Alabama | 36604-3302 | — |
| Xenoscience, Inc /ID# 217110 | Phoenix | Arizona | 85004 | — |
| Barrow Neurological Institute /ID# 216566 | Phoenix | Arizona | 85013-4407 | — |
| HonorHealth /ID# 216642 | Phoenix | Arizona | 85018-2111 | — |
| Movement Disorders Center of Arizona /ID# 216503 | Scottsdale | Arizona | 85258-4582 | — |
| Banner Sun Health Res Inst /ID# 216507 | Sun City | Arizona | 85351 | — |
| University of Arkansas for Medical Sciences /ID# 216501 | Little Rock | Arkansas | 72205 | — |
| The Parkinson's & Movement Disorder Institute - Fountain Valley /ID# 216705 | Fountain Valley | California | 92708 | — |
| Neuro Pain Medical Center /ID# 216551 | Fresno | California | 93710-5473 | — |
| University of California, San /ID# 216598 | La Jolla | California | 92093 | — |
| Loma Linda University Medical /ID# 216500 | Loma Linda | California | 92354 | — |
| Collaborative Neuroscience Research - Long Beach /ID# 216970 | Long Beach | California | 90806 | — |
| University of California, Los Angeles /ID# 216674 | Los Angeles | California | 90095 | — |
| SC3 Research Group - Pasadena /ID# 216821 | Pasadena | California | 91105-3149 | — |
| Cedars-Sinai Medical Center-West Hollywood /ID# 216561 | West Hollywood | California | 90048 | — |
| University of Colorado Hospital /ID# 216527 | Aurora | Colorado | 80045 | — |
| Alpine Clinical Research Center /ID# 216637 | Boulder | Colorado | 80301-1880 | — |
| Denver Neurological Research, LLC /ID# 216784 | Denver | Colorado | 80210-7009 | — |
| Rocky Mountain Movement Disorders Center /ID# 216737 | Englewood | Colorado | 80113-2736 | — |
| Christiana Care Health Service /ID# 216515 | Newark | Delaware | 19713 | — |
| Georgetown University Hospital /ID# 216632 | Washington D.C. | District of Columbia | 20007 | — |
| Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 216517 | Boca Raton | Florida | 33486 | — |
| Brain Matters Research /ID# 217089 | Delray Beach | Florida | 33445 | — |
| Fixel Institute for Neurological Diseases /ID# 216514 | Gainesville | Florida | 32608-3928 | — |
| Visionary Investigators Network - Miami /ID# 216679 | Miami | Florida | 33176-2148 | — |
| Renstar Medical Research /ID# 216765 | Ocala | Florida | 34470 | — |
| Neurology Associates Ormond Beach /ID# 216521 | Ormond Beach | Florida | 32174 | — |
| Parkinson's Disease Treatment Center of Southwest Florida /ID# 222656 | Port Charlotte | Florida | 33980 | — |
| University of South Florida /ID# 216638 | Tampa | Florida | 33612 | — |
| Premiere Research Institute - Palm Beach /ID# 217207 | West Palm Beach | Florida | 33407-3209 | — |
| Duplicate_Atlanta Center for Medical Res /ID# 217091 | Atlanta | Georgia | 30331 | — |
| The Neurological Center of North Georgia /ID# 216499 | Gainesville | Georgia | 30501 | — |
| Rush University Medical Center /ID# 216567 | Chicago | Illinois | 60612 | — |
| University of Chicago Medical /ID# 217187 | Chicago | Illinois | 60637 | — |
| Indiana Clinical Research Cent /ID# 216615 | Indianapolis | Indiana | 46202 | — |
| Univ Kansas Med Ctr /ID# 216528 | Kansas City | Kansas | 66160 | — |
| St Elizabeth's Medical Center - Brighton /ID# 216716 | Brighton | Massachusetts | 02135-2907 | — |
| Michigan State University /ID# 217158 | East Lansing | Michigan | 48824 | — |
| Clinical Research Professionals - Chesterfield /ID# 216669 | Chesterfield | Missouri | 63005-1205 | — |
| St. Luke's Hosp. of Kansas City /ID# 216633 | Kansas City | Missouri | 64111 | — |
| Washington University-School of Medicine /ID# 216548 | St Louis | Missouri | 63110 | — |
| Global Neurosciences Institute /ID# 217875 | Lawrenceville | New Jersey | 08648-2300 | — |
| Northwell Health /ID# 216833 | Lake Success | New York | 11042 | — |
| Mount Sinai Beth Israel /ID# 216712 | New York | New York | 10003 | — |
| University of Rochester /ID# 218737 | Rochester | New York | 14642-0001 | — |
| Wake Forest Univ HS /ID# 216522 | Winston-Salem | North Carolina | 27157 | — |
| Ohio State University - Wexner Medical Center /ID# 216900 | Columbus | Ohio | 43210-1229 | — |
| The Orthopedic Foundation /ID# 217157 | New Albany | Ohio | 43054-8167 | — |
| The Movement Disorder Clinic of Oklahoma /ID# 216860 | Tulsa | Oklahoma | 74136-6378 | — |
| Legacy Research Institute /ID# 216558 | Portland | Oregon | 97232-2003 | — |
| University of Pennsylvania /ID# 216560 | Philadelphia | Pennsylvania | 19104-5502 | — |
| Thomas Jefferson University Hospital /ID# 216553 | Philadelphia | Pennsylvania | 19107 | — |
| Prisma Health-Upstate /ID# 216594 | Greenville | South Carolina | 29615 | — |
| Premier Neurology, P.C. /ID# 217308 | Greer | South Carolina | 29650 | — |
| Coastal Neurology /ID# 217190 | Port Royal | South Carolina | 29935-2029 | — |
| KCA Neurology - Franklin /ID# 217419 | Franklin | Tennessee | 37067-5914 | — |
| Vanderbilt University Medical Center /ID# 216675 | Nashville | Tennessee | 37232-0011 | — |
| Houston Pulmonary Sleep and Allergy Associates /ID# 216942 | Cypress | Texas | 77429 | — |
| Kerwin Research Center /ID# 216587 | Dallas | Texas | 75231-4316 | — |
| Neurology Consultants of Dallas - LBJ Fwy /ID# 216564 | Dallas | Texas | 75243-1188 | — |
| Texas Movement Disorder Specialists /ID# 216523 | Georgetown | Texas | 78628-4126 | — |
| Houston Methodist Hospital /ID# 216707 | Houston | Texas | 77030 | — |
| Central Texas Neurology Consul /ID# 216629 | Round Rock | Texas | 78681 | — |
| University of Utah Health Care /ID# 216710 | Salt Lake City | Utah | 84132 | — |
| Meridian Clinical Research /ID# 216731 | Norfolk | Virginia | 23502-3932 | — |
| Neurological Associates - Forest Ave /ID# 216636 | Richmond | Virginia | 23229-4913 | — |
| Swedish Neuroscience /ID# 216526 | Seattle | Washington | 98122-5788 | — |
| Inland Northwest Research /ID# 221036 | Spokane | Washington | 99202-1342 | — |
| Medical College of Wisconsin /ID# 216498 | Milwaukee | Wisconsin | 53226-3522 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04380142, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 18, 2022 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04380142 live on ClinicalTrials.gov.