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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

Primary Purpose

Parkinson's Disease (PD)

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ABBV-951
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease (PD) focused on measuring Parkinson's Disease, PD, ABBV-951, Levodopa/Carbidopa (LD/CD), Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP)

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham - Main /ID# 217814
  • University of South Alabama /ID# 218467
  • Xenoscience, Inc /ID# 222515
  • Muhammad Ali Parkinson Center /ID# 218609
  • Movement Disorders Center of Arizona /ID# 218471
  • Neuro Pain Medical Center /ID# 217720
  • Loma Linda University Medical /ID# 217724
  • University of California, Los Angeles /ID# 218460
  • SC3 Research Group - Pasadena /ID# 223018
  • University of California, San /ID# 218595
  • Cedars-Sinai Medical Center-West Hollywood /ID# 218607
  • University of Colorado Hospital /ID# 218486
  • Alpine Clinical Research Center /ID# 218461
  • Denver Neurological Research, LLC /ID# 217811
  • CenExel Rocky Mountain Clinical Research, LLC /ID# 217731
  • Georgetown University Hospital /ID# 218599
  • Visionary Investigators Network - Miami /ID# 217726
  • Renstar Medical Research /ID# 217837
  • Neurology Associates Ormond Beach /ID# 217800
  • Parkinson's Disease Treatment Center of Southwest Florida /ID# 222679
  • University of South Florida /ID# 218481
  • Premiere Research Institute - Palm Beach /ID# 218743
  • Rush University Medical Center /ID# 217807
  • University of Chicago Medical /ID# 218611
  • St Elizabeth's Medical Center - Brighton /ID# 223082
  • St. Luke's Hosp. of Kansas City /ID# 218604
  • Washington University-School of Medicine /ID# 217723
  • Global Neurosciences Institute /ID# 218472
  • Northwell Health /ID# 218600
  • M3 Wake Research Inc. /ID# 218482
  • The Orthopedic Foundation /ID# 218608
  • The Movement Disorder Clinic of Oklahoma /ID# 218580
  • Legacy Medical Group - Neurology /ID# 217804
  • University of Pennsylvania /ID# 218605
  • Thomas Jefferson University Hospital /ID# 218594
  • Prisma Health-Upstate /ID# 217803
  • Coastal Neurology /ID# 222893
  • KCA Neurology - Franklin /ID# 222811
  • Vanderbilt University Medical Center /ID# 217722
  • St. David's Healthcare Partnership, L.P., LLP /ID# 248148
  • Houston Pulmonary Sleep and Allergy Associates /ID# 218473
  • Texas Movement Disorder Specialists /ID# 218610
  • Baylor College of Medicine - Baylor Medical Center /ID# 217728
  • University of Utah Health Care /ID# 218597
  • Neurological Associates - Forest Ave /ID# 218458
  • Inland Northwest Research /ID# 222520
  • Medical College of Wisconsin /ID# 217721
  • Liverpool Hospital /ID# 221693
  • Westmead Hospital /ID# 218418
  • Gold coast University Hospital /ID# 221694
  • Royal Adelaide Hospital /ID# 218417
  • The Royal Melbourne Hospital /ID# 218419

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ABBV-951

Arm Description

Participants will receive ABBV-951 by continuous subcutaneous infusion (CSCI) for 96 weeks during the Primary Treatment Period and during the optional Extended Treatment Period.

Outcomes

Primary Outcome Measures

Percentage of Participants with Adverse Event (AEs)
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 this treatment. An 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above.
Percentage of Participants with AEs of Special Interest (AESIs)
AESIs are defined as AEs from "special situations," such as accidental or intentional overdose, medication error, occupational or accidental exposure, off-label use, drug abuse, drug misuse, or drug withdrawal, all which must be reported whether associated with an AE or not.
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").
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").
Change From Baseline in Suicidality as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS is a systematically administered instrument designed to assess suicidal behavior and ideation, track and assess all suicidal events, and assess the lethality of attempts. Any participant who has suicidal behavior or suicidal ideation with plan since the last C-SSRS completed, will be evaluated immediately by the investigator.
Change From Baseline in Impulsive-Compulsive Disorders and related behaviors as assessed in Parkinson's Disease- Rating Scale (QUIP-RS)
The QUIP-RS is a brief, self-completed or rater-administered rating scale to assess the severity of symptoms of impulse control disorders (ICDs) and related behaviors reported to occur in PD. The QUIP-RS uses a 5-point Likert scale that requires individuals to rate the severity of each symptom based on its frequency.
Change From Baseline in Cognitive Impairment as Assessed by the Mini-Mental State Examination (MMSE)
Cognitive impairment is assessed by the Mini-Mental State Examination (MMSE). MMSE is a brief 30-point questionnaire, administered by a trained rater, that provides a quantitative measure of cognitive status in adults and is used widely to screen for cognitive impairment and to estimate the severity of cognitive impairment at a given point in time, to follow the course of changes in a patient over time, and to document response to treatment.
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed.
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed..
Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements like Systolic and Diastolic Blood Pressure will be Assessed
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Change From Baseline in Electrocardiograms (ECGs)
12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.

Secondary Outcome Measures

Change From Baseline in Average Normalized "On" Time as Assessed by the Parkinson's Disease (PD) Diary
Change in "On" time without dyskinesia or with non-troublesome dyskinesia as assessed by the PD diary.
Change From Baseline in Average Daily Normalized "Off" Time as Assessed by the PD Diary
Change in average daily normalized "Off" Time (Hours) is assessed based on PD Diary.
Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part I
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.
Change From Baseline in Motor Experiences of Daily Living
Motor experiences of daily living is assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II. 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.
Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part III
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.
Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part 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.
Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Parts I-III
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.
Change From Baseline in Sleep Symptoms
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.
Change From Baseline in Quality Of Life as Assessed by the PD Questionnaire-39 item (PDQ-39)
Quality of life is assessed by the PD Questionnaire-39 item (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.
Change From Baseline in Health-related Quality of Life as Assessed by EQ-5D-5L
Health-related quality of life is assessed by 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 (EQ-VAS).
Percentage Of Participants With Early Morning "Off" Assessed by the PD Diary as Percentage of Participants with early morning "Off" Upon Waking Up
Early morning "Off" status is assessed by the PD Diary as percentage of participants with early morning "Off" upon waking up.

Full Information

First Posted
February 10, 2021
Last Updated
September 4, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT04750226
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 18, 2021 (Actual)
Primary Completion Date
May 16, 2025 (Anticipated)
Study Completion Date
May 16, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease (PD)
Keywords
Parkinson's Disease, PD, ABBV-951, Levodopa/Carbidopa (LD/CD), Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABBV-951
Arm Type
Experimental
Arm Description
Participants will receive ABBV-951 by continuous subcutaneous infusion (CSCI) for 96 weeks during the Primary Treatment Period and during the optional Extended Treatment Period.
Intervention Type
Drug
Intervention Name(s)
ABBV-951
Other Intervention Name(s)
Foscarbidopa, Foslevodopa
Intervention Description
Solution for continuous subcutaneous infusion (CSCI).
Primary Outcome Measure Information:
Title
Percentage of Participants with Adverse Event (AEs)
Description
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 this treatment. An 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above.
Time Frame
Up to Week 96
Title
Percentage of Participants with AEs of Special Interest (AESIs)
Description
AESIs are defined as AEs from "special situations," such as accidental or intentional overdose, medication error, occupational or accidental exposure, off-label use, drug abuse, drug misuse, or drug withdrawal, all which must be reported whether associated with an AE or not.
Time Frame
Up to Week 96
Title
Percentage Of Participants With Numeric Grade Equal To Or Higher Than 5 On The Infusion Site Evaluation Scale
Description
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
Title
Percentage Of Participants With Letter Grade Equal To Or Higher Than D On The Infusion Site Evaluation Scale
Description
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
Title
Change From Baseline in Suicidality as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
C-SSRS is a systematically administered instrument designed to assess suicidal behavior and ideation, track and assess all suicidal events, and assess the lethality of attempts. Any participant who has suicidal behavior or suicidal ideation with plan since the last C-SSRS completed, will be evaluated immediately by the investigator.
Time Frame
Up To Week 96
Title
Change From Baseline in Impulsive-Compulsive Disorders and related behaviors as assessed in Parkinson's Disease- Rating Scale (QUIP-RS)
Description
The QUIP-RS is a brief, self-completed or rater-administered rating scale to assess the severity of symptoms of impulse control disorders (ICDs) and related behaviors reported to occur in PD. The QUIP-RS uses a 5-point Likert scale that requires individuals to rate the severity of each symptom based on its frequency.
Time Frame
Up To Week 96
Title
Change From Baseline in Cognitive Impairment as Assessed by the Mini-Mental State Examination (MMSE)
Description
Cognitive impairment is assessed by the Mini-Mental State Examination (MMSE). MMSE is a brief 30-point questionnaire, administered by a trained rater, that provides a quantitative measure of cognitive status in adults and is used widely to screen for cognitive impairment and to estimate the severity of cognitive impairment at a given point in time, to follow the course of changes in a patient over time, and to document response to treatment.
Time Frame
Up To Week 96
Title
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed.
Description
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed..
Time Frame
Up to Week 96
Title
Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements like Systolic and Diastolic Blood Pressure will be Assessed
Description
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Time Frame
Up to Week 96
Title
Change From Baseline in Electrocardiograms (ECGs)
Description
12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.
Time Frame
Up to Week 96
Secondary Outcome Measure Information:
Title
Change From Baseline in Average Normalized "On" Time as Assessed by the Parkinson's Disease (PD) Diary
Description
Change in "On" time without dyskinesia or with non-troublesome dyskinesia as assessed by the PD diary.
Time Frame
Up To Week 96
Title
Change From Baseline in Average Daily Normalized "Off" Time as Assessed by the PD Diary
Description
Change in average daily normalized "Off" Time (Hours) is assessed based on PD Diary.
Time Frame
Up To Week 96
Title
Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part I
Description
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
Title
Change From Baseline in Motor Experiences of Daily Living
Description
Motor experiences of daily living is assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II. 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
Title
Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part III
Description
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
Title
Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part IV
Description
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
Title
Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Parts I-III
Description
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
Title
Change From Baseline in Sleep Symptoms
Description
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.
Time Frame
Up To Week 96
Title
Change From Baseline in Quality Of Life as Assessed by the PD Questionnaire-39 item (PDQ-39)
Description
Quality of life is assessed by the PD Questionnaire-39 item (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
Title
Change From Baseline in Health-related Quality of Life as Assessed by EQ-5D-5L
Description
Health-related quality of life is assessed by 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 (EQ-VAS).
Time Frame
Up To Week 96
Title
Percentage Of Participants With Early Morning "Off" Assessed by the PD Diary as Percentage of Participants with early morning "Off" Upon Waking Up
Description
Early morning "Off" status is assessed by the PD Diary as percentage of participants with early morning "Off" upon waking up.
Time Frame
Up To Week 96

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham - Main /ID# 217814
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of South Alabama /ID# 218467
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604-3302
Country
United States
Facility Name
Xenoscience, Inc /ID# 222515
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Muhammad Ali Parkinson Center /ID# 218609
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013-4407
Country
United States
Facility Name
Movement Disorders Center of Arizona /ID# 218471
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258-4582
Country
United States
Facility Name
Neuro Pain Medical Center /ID# 217720
City
Fresno
State/Province
California
ZIP/Postal Code
93710-5473
Country
United States
Facility Name
Loma Linda University Medical /ID# 217724
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
University of California, Los Angeles /ID# 218460
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
SC3 Research Group - Pasadena /ID# 223018
City
Pasadena
State/Province
California
ZIP/Postal Code
91105-3149
Country
United States
Facility Name
University of California, San /ID# 218595
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Cedars-Sinai Medical Center-West Hollywood /ID# 218607
City
West Hollywood
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of Colorado Hospital /ID# 218486
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Alpine Clinical Research Center /ID# 218461
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301-1880
Country
United States
Facility Name
Denver Neurological Research, LLC /ID# 217811
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210-7009
Country
United States
Facility Name
CenExel Rocky Mountain Clinical Research, LLC /ID# 217731
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113-2736
Country
United States
Facility Name
Georgetown University Hospital /ID# 218599
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Visionary Investigators Network - Miami /ID# 217726
City
Miami
State/Province
Florida
ZIP/Postal Code
33176-2148
Country
United States
Facility Name
Renstar Medical Research /ID# 217837
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Neurology Associates Ormond Beach /ID# 217800
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Parkinson's Disease Treatment Center of Southwest Florida /ID# 222679
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33980
Country
United States
Facility Name
University of South Florida /ID# 218481
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Premiere Research Institute - Palm Beach /ID# 218743
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407-3209
Country
United States
Facility Name
Rush University Medical Center /ID# 217807
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Medical /ID# 218611
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
St Elizabeth's Medical Center - Brighton /ID# 223082
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135-2907
Country
United States
Facility Name
St. Luke's Hosp. of Kansas City /ID# 218604
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Washington University-School of Medicine /ID# 217723
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Global Neurosciences Institute /ID# 218472
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648-2300
Country
United States
Facility Name
Northwell Health /ID# 218600
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
M3 Wake Research Inc. /ID# 218482
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612-8106
Country
United States
Facility Name
The Orthopedic Foundation /ID# 218608
City
New Albany
State/Province
Ohio
ZIP/Postal Code
43054-8167
Country
United States
Facility Name
The Movement Disorder Clinic of Oklahoma /ID# 218580
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136-6378
Country
United States
Facility Name
Legacy Medical Group - Neurology /ID# 217804
City
Portland
State/Province
Oregon
ZIP/Postal Code
97232-2003
Country
United States
Facility Name
University of Pennsylvania /ID# 218605
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-5502
Country
United States
Facility Name
Thomas Jefferson University Hospital /ID# 218594
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Prisma Health-Upstate /ID# 217803
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Coastal Neurology /ID# 222893
City
Port Royal
State/Province
South Carolina
ZIP/Postal Code
29935-2029
Country
United States
Facility Name
KCA Neurology - Franklin /ID# 222811
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067-5914
Country
United States
Facility Name
Vanderbilt University Medical Center /ID# 217722
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-0011
Country
United States
Facility Name
St. David's Healthcare Partnership, L.P., LLP /ID# 248148
City
Austin
State/Province
Texas
ZIP/Postal Code
78701-4082
Country
United States
Facility Name
Houston Pulmonary Sleep and Allergy Associates /ID# 218473
City
Cypress
State/Province
Texas
ZIP/Postal Code
77429
Country
United States
Facility Name
Texas Movement Disorder Specialists /ID# 218610
City
Georgetown
State/Province
Texas
ZIP/Postal Code
78628-4126
Country
United States
Facility Name
Baylor College of Medicine - Baylor Medical Center /ID# 217728
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-3411
Country
United States
Facility Name
University of Utah Health Care /ID# 218597
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Neurological Associates - Forest Ave /ID# 218458
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229-4913
Country
United States
Facility Name
Inland Northwest Research /ID# 222520
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202-1342
Country
United States
Facility Name
Medical College of Wisconsin /ID# 217721
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3522
Country
United States
Facility Name
Liverpool Hospital /ID# 221693
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Westmead Hospital /ID# 218418
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Gold coast University Hospital /ID# 221694
City
SouthPort
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Royal Adelaide Hospital /ID# 218417
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
The Royal Melbourne Hospital /ID# 218419
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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, analyses plans, 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.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing 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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/

Learn more about this trial

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

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