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
Purpose
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.
Condition
- Parkinson's Disease (PD)
Eligibility
- Eligible Ages
- Over 30 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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. - Has no known active Coronavirus Disease - 2019 (COVID-19) infection.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
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 |
|
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 |
|
Recruiting Locations
Birmingham, Alabama 35233
Mobile, Alabama 36604-3302
Phoenix, Arizona 85004
Phoenix, Arizona 85013-4407
Scottsdale, Arizona 85258-4582
Sun City, Arizona 85351
Little Rock, Arkansas 72205
Fountain Valley, California 92708
Fresno, California 93710-5473
La Jolla, California 92093
Loma Linda, California 92354
Long Beach, California 90806
Los Angeles, California 90095
Pasadena, California 91105-3149
West Hollywood, California 90048
Aurora, Colorado 80045
Boulder, Colorado 80301-1880
Denver, Colorado 80210-7009
Englewood, Colorado 80113-2736
Newark, Delaware 19713
Washington, District of Columbia 20007
Boca Raton, Florida 33486
Delray Beach, Florida 33445
Gainesville, Florida 32608-3928
Miami, Florida 33176-2148
Ocala, Florida 34470
Ormond Beach, Florida 32174
Port Charlotte, Florida 33980
Tampa, Florida 33612
West Palm Beach, Florida 33407-3209
Gainesville, Georgia 30501
Chicago, Illinois 60612
Chicago, Illinois 60637
Indianapolis, Indiana 46202
Kansas City, Kansas 66160
East Lansing, Michigan 48824
Chesterfield, Missouri 63005-1205
Kansas City, Missouri 64111
Saint Louis, Missouri 63110
Lawrenceville, New Jersey 08648-2300
Lake Success, New York 11042
New York, New York 10003
Winston-Salem, North Carolina 27157
Columbus, Ohio 43210-1229
New Albany, Ohio 43054-8167
Tulsa, Oklahoma 74136-6378
Portland, Oregon 97232-2003
Philadelphia, Pennsylvania 19104-5502
Greenville, South Carolina 29615-3593
Greer, South Carolina 29650
Port Royal, South Carolina 29935-2029
Franklin, Tennessee 37067-5914
Nashville, Tennessee 37232-0011
Cypress, Texas 77429
Dallas, Texas 75231-4316
Dallas, Texas 75243-1188
Georgetown, Texas 78628-4126
Houston, Texas 77030
Round Rock, Texas 78681
Salt Lake City, Utah 84132
Norfolk, Virginia 23502-3932
Richmond, Virginia 23229-4913
Seattle, Washington 98122-5788
Spokane, Washington 99202-1342
Milwaukee, Wisconsin 53226-3522
More Details
- NCT ID
- NCT04380142
- Status
- Recruiting
- Sponsor
- AbbVie