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. The purpose of this study is to continue testing whether ABBV-951 is safe, effective, and tolerable in participants with Parkinson's disease after completion of the parent study M15-741. ABBV-951 is an investigational (unapproved) drug containing levodopa phosphate/carbidopa phosphate (LDP/CDP) given as infusion under the skin for the treatment of Parkinson's Disease. Participants who have successfully completed M15-741 study will immediately enter this study's treatment period to continue receiving ABBV-951. Adult participants with advanced PD will be enrolled. Approximately 130 adult participants will be enrolled in the study at approximately 65 sites worldwide. Participants will receive continuous subcutaneous infusion (CSCI) of ABBV-951 for 24 hours daily during the Primary Treatment Period and during the optional Extended Treatment Period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular clinic visits and have remote assessments completed via phone calls during the course of the study. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Solution for continuous subcutaneous infusion (CSCI).
University of Alabama at Birmingham - Main /ID# 215597
Birmingham, Alabama, United States
Banner Sun Health Research Institute /ID# 215579
Sun City, Arizona, United States
University of Colorado Hospital /ID# 215625
Aurora, Colorado, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 215412
Boca Raton, Florida, United States
Indiana Clinical Research Cent /ID# 216490
Indianapolis, Indiana, United States
Percentage of Participants With Adverse Events (AE)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of the study drug or device as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Adverse Events of Special Interest (AESI) - polyneuropathy, weight loss, hallucinations/psychosis, and somnolence will be monitored throughout the study.
Time frame: Up To Week 96
Percentage Of Participants With Numeric Grade Equal To Or Higher Than 5 On The Infusion Site Evaluation Scale
The Infusion Site Evaluation Scale will be used to assess infusion sites. Infusion Site Evaluation Scale is an eight-point numeric scale used to assess irritation at the infusion site area (0 being "no evidence of irritation" and 7 being "strong reaction spreading beyond the test site").
Time frame: Up To Week 96
Percentage Of Participants With Letter Grade Equal To Or Higher Than D On The Infusion Site Evaluation Scale
The Infusion Site Evaluation Scale will be used to assess infusion sites. Infusion Site Evaluation Scale is an A to G letter grade scale, used to assess irritation at the infusion site area (A being "no finding" to G being "Small petechial erosions and/or scabs").
Time frame: Up To Week 96
Change in Clinical Laboratory Test Data
Number of participants with clinically significant change from baseline in laboratory parameters (hematology, biochemistry, coagulation, and urinalysis) will be reported throughout the study.
Time frame: Up To Week 96
Change in Vital Signs Measurements
Number of participants with clinically significant change from baseline in vital signs will be reported throughout the study.
Time frame: Up To Week 96
Change From Baseline in Electrocardiograms (ECGs)
Change from baseline in 12-lead ECGs on heart rate, RR interval, PR interval, QRS duration, and QT interval will be monitored throughout the study.
Time frame: Up To Week 96
Average Normalized Daily "Off" Time
Average normalized daily "Off" Time (Hours) is assessed based on Parkinson's Disease (PD) Diary.
Time frame: Up To Week 96
Average Normalized Daily "On" Time
Average normalized daily "On" time is assessed based on Parkinson's Disease (PD) Diary.
Time frame: Up To Week 96
Parkinson's Disease (PD) Symptoms Measurement
PD symptoms will be assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-IV. 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.
Time frame: Up To Week 96
Change From Baseline in Quality Of Life Measurement as Assessed by PD Questionnaire-39 (PDQ-39)
Quality of life is assessed by the PD Questionnaire-39 items (PDQ-39). PDQ-39 is a disease-specific instrument designed to measure aspects of health that are relevant to participants with PD, and which may not be included in general health status questionnaires. Each item is scored on a 5-point scale.
Time frame: Up To Week 96
Change From Baseline in Health-related Quality Of Life Measurement as Assessed by EuroQol 5-dimensions questionnaire (EQ-5D-5L)
Health-related quality of life is assessed by the EuroQol 5-dimensions questionnaire (EQ-5D-5L). EQ-5D-5L is a standardized instrument that consists of 2 parts: the EQ-5D descriptive system and the EQ visual analogue-scale (EQVAS).
Time frame: Up To Week 96
Cognitive Impairment Measurement
Cognitive impairment is assessed by the Mini-Mental State Examination (MMSE). MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score of 0 to 30, with higher scores indicating better function.
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Univ Kansas Med Ctr /ID# 215624
Kansas City, Kansas, United States
Washington University-School of Medicine /ID# 215472
St Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center /ID# 216834
Lebanon, New Hampshire, United States
M3 Wake Research - Raleigh /ID# 215596
Raleigh, North Carolina, United States
Legacy Medical Group - Neurology /ID# 215536
Portland, Oregon, United States
...and 41 more locations
Time frame: Up To Week 96