Clinical trial NCT04750226: Study To Assess Adverse Events and Change in Disease Activity Of 24-hour Continuous Subcutaneous Infusion Of ABBV-951 In Adult Participants With Advanced Parkinson's Disease
Official title: An Open-Label Extension of Studies M15-736 and M20-339 to Evaluate the Safety and Tolerability of 24-Hour Daily Exposure of ABBV-951 in Subjects With Advanced Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Parkinson's Disease (PD)
Keywords: Parkinson's Disease
PD
ABBV-951
Levodopa/Carbidopa (LD/CD)
Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-02-11
Enrollment: 118
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 will assess how safe and effective ABBV-951 is in adult participants with PD. Adverse events and change in disease activity is evaluated.

ABBV-951 is an investigational (unapproved) drug containing Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP) given as an infusion under the skin for the treatment of Parkinson's Disease. Adult participants with advanced PD and who have completed M15-736 or M20-339 study will be enrolled. Approximately 130 participants will be enrolled in the study in approximately 60 sites in the United States and Australia.

Participants will receive continuous subcutaneous infusion (CSCI) (under the skin) of ABBV-951 for 96 weeks 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 visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical and remote telephone assessments, blood tests, checking for side effects, and completing questionnaires.


Eligibility criteria: Inclusion Criteria:

- Completion of the parent study, Study M15-736 or Study M20-339.

Exclusion Criteria:

- Participant considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason.

Primary outcomes:
measure: Percentage of Participants with Adverse Event (AEs)
timeFrame: Up to Week 96
measure: Percentage of Participants with AEs of Special Interest (AESIs)
timeFrame: Up to Week 96
measure: Percentage Of Participants With Numeric Grade Equal To Or Higher Than 5 On The Infusion Site Evaluation Scale
timeFrame: Up To Week 96
measure: Percentage Of Participants With Letter Grade Equal To Or Higher Than D On The Infusion Site Evaluation Scale
timeFrame: Up To Week 96
measure: Change From Baseline in Suicidality as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Up To Week 96
measure: Change From Baseline in Impulsive-Compulsive Disorders and related behaviors as assessed in Parkinson's Disease- Rating Scale (QUIP-RS)
timeFrame: Up To Week 96
measure: Change From Baseline in Cognitive Impairment as Assessed by the Mini-Mental State Examination (MMSE)
timeFrame: Up To Week 96
measure: Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed.
timeFrame: Up to Week 96
measure: Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements like Systolic and Diastolic Blood Pressure will be Assessed
timeFrame: Up to Week 96
measure: Change From Baseline in Electrocardiograms (ECGs)
timeFrame: Up to Week 96
Secondary outcomes:
measure: Change From Baseline in Average Normalized "On" Time as Assessed by the Parkinson's Disease (PD) Diary
timeFrame: Up To Week 96
measure: Change From Baseline in Average Daily Normalized "Off" Time as Assessed by the PD Diary
timeFrame: Up To Week 96
measure: Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part I
timeFrame: Up To Week 96
measure: Change From Baseline in Motor Experiences of Daily Living
timeFrame: Up To Week 96
measure: Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part III
timeFrame: Up To Week 96
measure: Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part IV
timeFrame: Up To Week 96
measure: Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Parts I-III
timeFrame: Up To Week 96
measure: Change From Baseline in Sleep Symptoms
timeFrame: Up To Week 96
measure: Change From Baseline in Quality Of Life as Assessed by the PD Questionnaire-39 item (PDQ-39)
timeFrame: Up To Week 96
measure: Change From Baseline in Health-related Quality of Life as Assessed by EQ-5D-5L
timeFrame: Up To Week 96
measure: Percentage Of Participants With Early Morning "Off" Assessed by the PD Diary as Percentage of Participants with early morning "Off" Upon Waking Up
timeFrame: Up To Week 96
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham - Main /ID# 217814
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama /ID# 218467
state: Alabama
city: Phoenix
country: United States
facility: Xenoscience, Inc /ID# 222515
state: Arizona
city: Phoenix
country: United States
facility: Muhammad Ali Parkinson Center /ID# 218609
state: Arizona
city: Scottsdale
country: United States
facility: Movement Disorders Center of Arizona /ID# 218471
state: Arizona
city: Fresno
country: United States
facility: Neuro Pain Medical Center /ID# 217720
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical /ID# 217724
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles /ID# 218460
state: California
city: Pasadena
country: United States
facility: SC3 Research Group - Pasadena /ID# 223018
state: California
city: San Diego
country: United States
facility: University of California, San /ID# 218595
state: California
city: West Hollywood
country: United States
facility: Cedars-Sinai Medical Center-West Hollywood /ID# 218607
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital /ID# 218486
state: Colorado
city: Boulder
country: United States
facility: Alpine Clinical Research Center /ID# 218461
state: Colorado
city: Denver
country: United States
facility: Denver Neurological Research, LLC /ID# 217811
state: Colorado
city: Englewood
country: United States
facility: CenExel Rocky Mountain Clinical Research, LLC /ID# 217731
state: Colorado
city: Washington
country: United States
facility: Georgetown University Hospital /ID# 218599
state: District of Columbia
city: Miami
country: United States
facility: Visionary Investigators Network - Miami /ID# 217726
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research /ID# 217837
state: Florida
city: Ormond Beach
country: United States
facility: Neurology Associates Ormond Beach /ID# 217800
state: Florida
city: Port Charlotte
country: United States
facility: Parkinson's Disease Treatment Center of Southwest Florida /ID# 222679
state: Florida
city: Tampa
country: United States
facility: University of South Florida /ID# 218481
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute - Palm Beach /ID# 218743
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center /ID# 217807
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical /ID# 218611
state: Illinois
city: Brighton
country: United States
facility: St Elizabeth's Medical Center - Brighton /ID# 223082
state: Massachusetts
city: Kansas City
country: United States
facility: St. Luke's Hosp. of Kansas City /ID# 218604
state: Missouri
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 217723
state: Missouri
city: Lawrenceville
country: United States
facility: Global Neurosciences Institute /ID# 218472
state: New Jersey
city: Lake Success
country: United States
facility: Northwell Health /ID# 218600
state: New York
city: Raleigh
country: United States
facility: M3 Wake Research Inc. /ID# 218482
state: North Carolina
city: New Albany
country: United States
facility: The Orthopedic Foundation /ID# 218608
state: Ohio
city: Tulsa
country: United States
facility: The Movement Disorder Clinic of Oklahoma /ID# 218580
state: Oklahoma
city: Portland
country: United States
facility: Legacy Medical Group - Neurology /ID# 217804
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania /ID# 218605
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital /ID# 218594
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma Health-Upstate /ID# 217803
state: South Carolina
city: Port Royal
country: United States
facility: Coastal Neurology /ID# 222893
state: South Carolina
city: Franklin
country: United States
facility: KCA Neurology - Franklin /ID# 222811
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center /ID# 217722
state: Tennessee
city: Austin
country: United States
facility: St. David's Healthcare Partnership, L.P., LLP /ID# 248148
state: Texas
city: Cypress
country: United States
facility: Houston Pulmonary Sleep and Allergy Associates /ID# 218473
state: Texas
city: Georgetown
country: United States
facility: Texas Movement Disorder Specialists /ID# 218610
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine - Baylor Medical Center /ID# 217728
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Care /ID# 218597
state: Utah
city: Richmond
country: United States
facility: Neurological Associates - Forest Ave /ID# 218458
state: Virginia
city: Spokane
country: United States
facility: Inland Northwest Research /ID# 222520
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin /ID# 217721
state: Wisconsin
city: Liverpool
country: Australia
facility: Liverpool Hospital /ID# 221693
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital /ID# 218418
state: New South Wales
city: SouthPort
country: Australia
facility: Gold coast University Hospital /ID# 221694
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital /ID# 218417
state: South Australia
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital /ID# 218419
state: Victoria
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: