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History of Changes for Study: NCT04380142
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
Latest version (submitted October 27, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 6, 2020 None (earliest Version on record)
2 May 26, 2020 Contacts/Locations and Study Status
3 July 30, 2020 Recruitment Status, Contacts/Locations, Study Status and IPDSharing
4 August 25, 2020 Contacts/Locations and Study Status
5 September 23, 2020 Contacts/Locations and Study Status
6 November 9, 2020 Study Status, Contacts/Locations and Eligibility
7 December 7, 2020 Contacts/Locations and Study Status
8 December 29, 2020 Contacts/Locations and Study Status
9 February 17, 2021 Contacts/Locations and Study Status
10 March 30, 2021 Study Status and Contacts/Locations
11 April 21, 2021 Study Status, Contacts/Locations and Eligibility
12 May 21, 2021 Recruitment Status, Contacts/Locations and Study Status
13 May 25, 2021 Study Status
14 September 30, 2021 Contacts/Locations and Study Status
15 October 7, 2021 Recruitment Status, Study Status, Outcome Measures, Contacts/Locations and Study Design
16 August 16, 2022
Quality Control Review has not concluded Returned: September 8, 2022
Outcome Measures, Study Status, IPDSharing, Document Section, Contacts/Locations, Eligibility, Arms and Interventions and Study Description
17 September 26, 2022
Quality Control Review has not concluded Returned: October 20, 2022
Outcome Measures, Study Status and Adverse Events
18 October 27, 2022 Study Status, Outcome Measures and Adverse Events
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Study NCT04380142
Submitted Date:  May 6, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: M15-736
Brief Title: 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
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
Secondary IDs: 2019-003930-18 [EudraCT Number]
Open or close this module Study Status
Record Verification: May 2020
Overall Status: Not yet recruiting
Study Start: July 13, 2020
Primary Completion: January 27, 2021 [Anticipated]
Study Completion: February 24, 2021 [Anticipated]
First Submitted: May 6, 2020
First Submitted that
Met QC Criteria:
May 6, 2020
First Posted: May 8, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
May 6, 2020
Last Update Posted: May 8, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: AbbVie
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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. The study has two treatment arms . In one arm, participants will be given ABBV-951 plus oral placebo (does not contain treatment drug). In the second arm, participants will be given placebo solution and LD/CD tablets. 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.

Detailed Description:
Open or close this module Conditions
Conditions: Parkinson's Disease (PD)
Keywords: Parkinson's Disease (PD)
ABBV-951
Levodopa/Carbidopa (LD/CD)
Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP)
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 130 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: ABBV-951 + Placebo for Levodopa/Carbidopa (LD/CD)
Participants will receive 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
Participants will receive 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)
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Change in "On" Time (Hours) Without Troublesome Dyskinesia
[ Time Frame: Baseline (Week 0) Up to Week 12 ]

"On" time without dyskinesia plus "On" time with non-troublesome dyskinesia are based on the Parkinson's Disease (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 in "Off" Time (Hours)
[ Time Frame: Baseline (Week 0) Up to Week 12 ]

"Off" time is assessed by the PD Diary.
2. Change in Motor Experiences of Daily Living
[ Time Frame: Baseline (Week 0) Up to Week 12 ]

Motor Experiences of Daily Living is assessed by Part II of Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The Part II MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD) with scores ranging from 0 to 52.
3. Change in Sleep Symptoms
[ Time Frame: Baseline (Week 0) Up to Week 12 ]

Sleep symptoms are assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2). The PDSS-2 consists of 15 questions that evaluate motor and non-motor symptoms at night and upon wakening, as well as disturbed sleep.
4. Change in Quality of Life Assessed by PD Questionnaire-39 item (PDQ-39)
[ Time Frame: Baseline (Week 0) Up to Week 12 ]

PDQ-39 is a disease-specific instrument designed to measure aspects of health that are relevant to subjects with PD, and which may not be included in general health status questionnaires.
5. Early Morning "Off" Status
[ Time Frame: At Week 12 ]

Early morning "Off" status is assessed by the PD Diary as percentage of participants with early morning "Off" upon waking up.
6. Change in Quality of Life Assessed by the EuroQol 5-Dimension Questionnaire (EQ-5D-5L)
[ Time Frame: Baseline (Week 0) Up to Week 12 ]

EQ-5D-5L is a standardized instrument developed by the EuroQol Group as a measure of health related quality of life that can be used in a wide range of health conditions and treatments.
7. Change in PD Symptoms as Assessed by the MDS-UPDRS Tool Part I
[ Time Frame: Baseline (Week 0) Up to Week 12 ]

The MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD) with scores ranging from 0 to 236 with 236 representing the worst disability, and 0 representing no disability.
8. Change in PD Symptoms as Assessed by the MDS-UPDRS Tool Part III
[ Time Frame: Baseline (Week 0) Up to Week 12 ]

The MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD) with scores ranging from 0 to 236 with 236 representing the worst disability, and 0 representing no disability.
9. Change in PD Symptoms as Assessed by the MDS-UPDRS Tool Part IV
[ Time Frame: Baseline (Week 0) Up to Week 12 ]

The MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD) with scores ranging from 0 to 236 with 236 representing the worst disability, and 0 representing no disability.
10. Change in PD Symptoms as Assessed by the MDS-UPDRS Tool Total Score of Parts I - III
[ Time Frame: Baseline (Week 0) Up to Week 12 ]

The MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD) with scores ranging from 0 to 236 with 236 representing the worst disability, and 0 representing no disability.
11. Change in PD Symptoms as Assessed by the Parkinson's KinetiGraph/Personal KinetiGraph (PKG) Wearable Device
[ Time Frame: Baseline (Week 0) Up to Week 12 ]

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.
Open or close this module Eligibility
Minimum Age: 30 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa-responsive.
  • Participants 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.
Open or close this module Contacts/Locations
Central Contact Person: ABBVIE CALL CENTER
Telephone: 847.283.8955
Email: abbvieclinicaltrials@abbvie.com
Study Officials: AbbVie Inc.
Study Director
AbbVie
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
Muhammad Ali Parkinson Center /ID# 216566
Phoenix, Arizona, United States, 85013-4407
HonorHealth Neurology/Phoenix Neurological Associates /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
Parkinson's and Movement /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
University of California, Los Angeles /ID# 216674
Los Angeles, California, United States, 90095
Parkinson's Institute and Clinical Center - Mountainview /ID# 216768
Mountain View, California, United States, 94040-4106
Stanford University School of Med /ID# 216726
Stanford, California, United States, 94305-2200
Cedars-Sinai Medical Center - West Hollywood /ID# 216561
West Hollywood, California, United States, 90048
United States, Colorado
University of Colorado Hosp /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
MedStar Georgetown University Hospital /ID# 216632
Washington, District of Columbia, United States, 20007
United States, Florida
Parkinson's Disease and Moveme /ID# 216517
Boca Raton, Florida, United States, 33486
Brain Matters Research /ID# 217089
Delray Beach, Florida, United States, 33445
University of Florida - Hull Rd /ID# 216514
Gainesville, Florida, United States, 32607
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
Progressive Medical Research /ID# 216525
Port Orange, Florida, United States, 32127
Roskamp Institute /ID# 216552
Sarasota, Florida, United States, 34243-3956
University of South Florida /ID# 216638
Tampa, Florida, United States, 33612
Premiere Research Institute at Palm Beach Neurology /ID# 217207
West Palm Beach, Florida, United States, 33407-3209
United States, Georgia
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
Southern Illinois University (SIU) Medicine /ID# 216721
Springfield, Illinois, United States, 62702-4933
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, Michigan
Michigan State University /ID# 217158
East Lansing, Michigan, United States, 48824
United States, Minnesota
Health Partners /ID# 216510
Saint Paul, Minnesota, United States, 55130-2400
United States, Missouri
Clinical Research Professionals - Chesterfield /ID# 216669
Chesterfield, Missouri, United States, 63005-1205
St. Luke's Hosp. of Kansas Cit /ID# 216633
Kansas City, Missouri, United States, 64111
Washington University-School of Medicine /ID# 216548
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Univ Nebraska Med Ctr /ID# 216497
Omaha, Nebraska, United States, 68198
United States, New Jersey
Global Neurosciences Institute /ID# 217875
Lawrenceville, New Jersey, United States, 08648-2300
The Cognitive Research Center of New Jersey (CRCNJ) /ID# 217281
Springfield, New Jersey, United States, 07081
United States, New York
Northwell Health - Great Neck /ID# 216833
Great Neck, New York, United States, 11021-5206
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
M3 Wake Research Inc. /ID# 216596
Raleigh, North Carolina, United States, 27612-8106
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
OrthoNeuro - New Albany /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
Lehigh Valley Health Network /ID# 216867
Allentown, Pennsylvania, United States, 18103
University of Pennsylvania /ID# 216560
Philadelphia, Pennsylvania, United States, 19104-5502
Thomas Jefferson University Hospital /ID# 216553
Philadelphia, Pennsylvania, United States, 19107
Allegheny Neurological Associates /ID# 216887
Pittsburgh, Pennsylvania, United States, 15212-4740
United States, South Carolina
Prisma Health /ID# 216594
Greenville, South Carolina, United States, 29615-3593
United States, Tennessee
Vanderbilt Univ Med Ctr /ID# 216675
Nashville, Tennessee, United States, 37232-0011
United States, Texas
Gill NeuroScience /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 Specialist /ID# 216523
Georgetown, Texas, United States, 78626-7724
Baylor College of Medicine /ID# 216506
Houston, Texas, United States, 77030-3411
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
Royal Brisbane and Women's Hospital /ID# 217512
Herston, Queensland, Australia, 4029
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
Alfred Hospital /ID# 216534
Melbourne, Victoria, Australia, 3004
Royal Melbourne Hospital /ID# 216536
Parkville, Victoria, Australia, 3050
Open or close this module IPDSharing
Plan to Share IPD: Yes
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 Information:
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame:
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Open or close this module References
Links:
Available IPD/Information:

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