Back to resultsExtension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's Disease
Primary Purpose
Parkinson's Disease (PD)
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ABBV-951
Sponsored by
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
Inclusion Criteria:
- Participants who have Parkinson's Disease and who have successfully completed the parent study M15-741.
- Participants willing and able to comply with procedures required in the protocol.
Exclusion Criteria:
- Participants, if judged by the investigator to be unsuitable candidates to continue to receive ABBV-951 for any reason.
Sites / Locations
- University of Alabama at Birmingham - Main /ID# 215597
- Banner Sun Health Res Inst /ID# 215579
- University of Colorado Hospital /ID# 215625
- Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 215412
- Indiana Clinical Research Cent /ID# 216490
- Univ Kansas Med Ctr /ID# 215624
- Washington University-School of Medicine /ID# 215472
- Dartmouth-Hitchcock Medical Center /ID# 216834
- M3 Wake Research Inc. /ID# 215596
- Legacy Medical Group - Neurology /ID# 215536
- Baylor College of Medicine - Baylor Medical Center /ID# 215401
- Central Texas Neurology Consul /ID# 217013
- Univ Texas HSC San Antonio /ID# 215400
- Booth Gardner Parkinson's Care Center /ID# 215535
- Inland Northwest Research /ID# 215533
- Concord Repatriation General Hospital /ID# 215943
- Westmead Hospital /ID# 215941
- Royal Adelaide Hospital /ID# 215940
- Alfred Health /ID# 215942
- Perron Institute /ID# 215944
- Universitair Ziekenhuis Leuven /ID# 215684
- AZ Sint-Jan Brugge /ID# 215686
- Groupe Sante CHC - Clinique du MontLegia /ID# 215685
- University of Calgary - Movement Disorders Clinic /ID# 215369
- Clinique Neuro Levis /ID# 215371
- Bispebjerg and Frederiksberg Hospital /ID# 215391
- Aarhus University Hospital /ID# 215392
- Odense University Hospital /ID# 215390
- Universitaetsklinikum Ulm /ID# 215405
- Kliniken Beelitz GmbH /ID# 215403
- InnKlinikum Haag /ID# 215404
- IRCCS Centro Neurolesi Bonino Pulejo /ID# 215422
- Azienda Ospedaliera di Padova /ID# 215421
- National Hospital Organization Asahikawa Medical Center /ID# 218762
- Osaka University Hospital /ID# 217415
- National Center of Neurology and Psychiatry /ID# 218763
- St. Antonius Ziekenhuis /ID# 215396
- City Clinical Hospital #40 /ID# 218870
- Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 218869
- Hospital General Universitario de Elche /ID# 215425
- Hospital Universitario de Bellvitge /ID# 215427
- Hospital Universitario A Coruna - CHUAC /ID# 215426
- Hospital Santa Creu i Sant Pau /ID# 215429
- Hospital Universitario Virgen de las Nieves /ID# 215431
- Hospital Universitario Virgen del Rocio /ID# 215428
- Skane University Hospital Lund /ID# 215385
- Sahlgrenska University Hospital /ID# 215387
- Karolinska University Hospital /ID# 215386
- NHS Tayside /ID# 217389
- King's College Hospital NHS Foundation Trust /ID# 217388
- University Hospital Plymouth NHS Trust /ID# 217390
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ABBV-951
Arm Description
Participants will receive ABBV-951 solution by continuous subcutaneous infusion (CSCI), at the discretion of the investigator, for up to 96 weeks.
Outcomes
Primary Outcome Measures
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.
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 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.
Change in Vital Signs Measurements
Number of participants with clinically significant change from baseline in vital signs will be reported throughout the study.
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.
Secondary Outcome Measures
Average Normalized Daily "Off" Time
Average normalized daily "Off" Time (Hours) is assessed based on Parkinson's Disease (PD) Diary.
Average Normalized Daily "On" Time
Average normalized daily "On" time is assessed based on Parkinson's Disease (PD) Diary.
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.
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.
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04379050
Brief Title
Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's Disease
Official Title
An Open-label Extension of Study M15-741 to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 8, 2020 (Actual)
Primary Completion Date
June 27, 2025 (Anticipated)
Study Completion Date
June 27, 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. 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.
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
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ABBV-951
Arm Type
Experimental
Arm Description
Participants will receive ABBV-951 solution by continuous subcutaneous infusion (CSCI), at the discretion of the investigator, for up to 96 weeks.
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 Events (AE)
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 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
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 in Clinical Laboratory Test Data
Description
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
Title
Change in Vital Signs Measurements
Description
Number of participants with clinically significant change from baseline in vital signs will be reported throughout the study.
Time Frame
Up To Week 96
Title
Change From Baseline in Electrocardiograms (ECGs)
Description
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
Secondary Outcome Measure Information:
Title
Average Normalized Daily "Off" Time
Description
Average normalized daily "Off" Time (Hours) is assessed based on Parkinson's Disease (PD) Diary.
Time Frame
Up To Week 96
Title
Average Normalized Daily "On" Time
Description
Average normalized daily "On" time is assessed based on Parkinson's Disease (PD) Diary.
Time Frame
Up To Week 96
Title
Parkinson's Disease (PD) Symptoms Measurement
Description
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
Title
Change From Baseline in Quality Of Life Measurement as Assessed by PD Questionnaire-39 (PDQ-39)
Description
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
Title
Change From Baseline in Health-related Quality Of Life Measurement as Assessed by EuroQol 5-dimensions questionnaire (EQ-5D-5L)
Description
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
Title
Cognitive Impairment Measurement
Description
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.
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:
Participants who have Parkinson's Disease and who have successfully completed the parent study M15-741.
Participants willing and able to comply with procedures required in the protocol.
Exclusion Criteria:
- Participants, if judged by the investigator to be unsuitable candidates to continue 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# 215597
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Banner Sun Health Res Inst /ID# 215579
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
University of Colorado Hospital /ID# 215625
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 215412
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Indiana Clinical Research Cent /ID# 216490
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Univ Kansas Med Ctr /ID# 215624
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Washington University-School of Medicine /ID# 215472
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center /ID# 216834
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
M3 Wake Research Inc. /ID# 215596
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612-8106
Country
United States
Facility Name
Legacy Medical Group - Neurology /ID# 215536
City
Portland
State/Province
Oregon
ZIP/Postal Code
97232-2003
Country
United States
Facility Name
Baylor College of Medicine - Baylor Medical Center /ID# 215401
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-3411
Country
United States
Facility Name
Central Texas Neurology Consul /ID# 217013
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Univ Texas HSC San Antonio /ID# 215400
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3901
Country
United States
Facility Name
Booth Gardner Parkinson's Care Center /ID# 215535
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034-3029
Country
United States
Facility Name
Inland Northwest Research /ID# 215533
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202-1342
Country
United States
Facility Name
Concord Repatriation General Hospital /ID# 215943
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Westmead Hospital /ID# 215941
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Adelaide Hospital /ID# 215940
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Alfred Health /ID# 215942
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Perron Institute /ID# 215944
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Universitair Ziekenhuis Leuven /ID# 215684
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Sint-Jan Brugge /ID# 215686
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Groupe Sante CHC - Clinique du MontLegia /ID# 215685
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
University of Calgary - Movement Disorders Clinic /ID# 215369
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
Clinique Neuro Levis /ID# 215371
City
Lévis
State/Province
Quebec
ZIP/Postal Code
G6W 0M5
Country
Canada
Facility Name
Bispebjerg and Frederiksberg Hospital /ID# 215391
City
Copenhagen NV
State/Province
Hovedstaden
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Aarhus University Hospital /ID# 215392
City
Aarhus N
State/Province
Midtjylland
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Odense University Hospital /ID# 215390
City
Odense C
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Universitaetsklinikum Ulm /ID# 215405
City
Ulm
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
Kliniken Beelitz GmbH /ID# 215403
City
Beelitz-Heilstaetten
ZIP/Postal Code
14547
Country
Germany
Facility Name
InnKlinikum Haag /ID# 215404
City
Haag
ZIP/Postal Code
83527
Country
Germany
Facility Name
IRCCS Centro Neurolesi Bonino Pulejo /ID# 215422
City
Messina
ZIP/Postal Code
98124
Country
Italy
Facility Name
Azienda Ospedaliera di Padova /ID# 215421
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
National Hospital Organization Asahikawa Medical Center /ID# 218762
City
Asahikawa-shi
State/Province
Hokkaido
ZIP/Postal Code
070-8644
Country
Japan
Facility Name
Osaka University Hospital /ID# 217415
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
National Center of Neurology and Psychiatry /ID# 218763
City
Kodaira-shi
State/Province
Tokyo
ZIP/Postal Code
187-8551
Country
Japan
Facility Name
St. Antonius Ziekenhuis /ID# 215396
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
City Clinical Hospital #40 /ID# 218870
City
Sestroretsk
State/Province
Sankt-Peterburg
ZIP/Postal Code
197706
Country
Russian Federation
Facility Name
Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 218869
City
St. Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197101
Country
Russian Federation
Facility Name
Hospital General Universitario de Elche /ID# 215425
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital Universitario de Bellvitge /ID# 215427
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario A Coruna - CHUAC /ID# 215426
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Santa Creu i Sant Pau /ID# 215429
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario Virgen de las Nieves /ID# 215431
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio /ID# 215428
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Skane University Hospital Lund /ID# 215385
City
Lund
State/Province
Skane Lan
ZIP/Postal Code
SE 221 41
Country
Sweden
Facility Name
Sahlgrenska University Hospital /ID# 215387
City
Gothenburg
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
413 46
Country
Sweden
Facility Name
Karolinska University Hospital /ID# 215386
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
NHS Tayside /ID# 217389
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD2 1UB
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust /ID# 217388
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
University Hospital Plymouth NHS Trust /ID# 217390
City
Plymouth
ZIP/Postal Code
PL6 5FP
Country
United Kingdom
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
Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's Disease
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