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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03781167




Registration number
NCT03781167
Ethics application status
Date submitted
18/12/2018
Date registered
19/12/2018

Titles & IDs
Public title
A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)
Scientific title
A 52-Week, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's Disease
Secondary ID [1] 0 0
2018-002144-85
Secondary ID [2] 0 0
M15-741
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease (PD) 0 0
Condition category
Condition code
Neurological 0 0 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABBV-951

Experimental: ABBV-951 Low Dose Subgroup - After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.

Experimental: ABBV-951 High Dose Subgroup - After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was = 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.


Treatment: Drugs: ABBV-951
Solution for continuous subcutaneous infusion (CSCI)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events
Timepoint [1] 0 0
From first dose of study drug until 30 days following last dose of study drug (up to 480 days)
Primary outcome [2] 0 0
Number of Participants With Adverse Events of Special Interest
Timepoint [2] 0 0
From first dose of study drug until 30 days following last dose of study drug (up to 480 days)
Primary outcome [3] 0 0
Number of Participants With Numeric Grade Equal to or Higher Than 5 and With Letter Grade Equal to or Higher Than D on the Infusion Site Evaluation Scale
Timepoint [3] 0 0
Day 1, Day 2, Week 1, Week 2, Week 3, Week 4, Week 6, Week 13, Week 26, Week 39, and Week 52
Primary outcome [4] 0 0
Hematocrit (Hematology): Change From Baseline to End of Study
Timepoint [4] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [5] 0 0
Hemoglobin (Hematology): Change From Baseline to End of Study
Timepoint [5] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [6] 0 0
Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study
Timepoint [6] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [7] 0 0
White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study
Timepoint [7] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [8] 0 0
Neutrophils (Hematology): Change From Baseline to End of Study
Timepoint [8] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [9] 0 0
Lymphocytes (Hematology): Change From Baseline to End of Study
Timepoint [9] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [10] 0 0
Monocytes (Hematology): Change From Baseline to End of Study
Timepoint [10] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [11] 0 0
Absolute Platelet Count (Hematology): Change From Baseline to End of Study
Timepoint [11] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [12] 0 0
Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study
Timepoint [12] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [13] 0 0
Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study
Timepoint [13] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [14] 0 0
Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study
Timepoint [14] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [15] 0 0
Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study
Timepoint [15] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [16] 0 0
Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study
Timepoint [16] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [17] 0 0
Creatinine (Clinical Chemistry): Change From Baseline to End of Study
Timepoint [17] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [18] 0 0
Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study
Timepoint [18] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [19] 0 0
Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study
Timepoint [19] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [20] 0 0
Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study
Timepoint [20] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [21] 0 0
Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study
Timepoint [21] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [22] 0 0
Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study
Timepoint [22] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [23] 0 0
Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study
Timepoint [23] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [24] 0 0
Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study
Timepoint [24] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [25] 0 0
Sodium (Clinical Chemistry): Change From Baseline to End of Study
Timepoint [25] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [26] 0 0
Potassium (Clinical Chemistry): Change From Baseline to End of Study
Timepoint [26] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [27] 0 0
Calcium (Clinical Chemistry): Change From Baseline to End of Study
Timepoint [27] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [28] 0 0
Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study
Timepoint [28] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [29] 0 0
Uric Acid (Clinical Chemistry): Change From Baseline to End of Study
Timepoint [29] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [30] 0 0
Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study
Timepoint [30] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [31] 0 0
Albumin (Clinical Chemistry): Change From Baseline to End of Study
Timepoint [31] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [32] 0 0
Glucose (Clinical Chemistry): Change From Baseline to End of Study
Timepoint [32] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [33] 0 0
Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study
Timepoint [33] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [34] 0 0
Magnesium (Clinical Chemistry): Change From Baseline to End of Study
Timepoint [34] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [35] 0 0
Creatinine Clearance (Clinical Chemistry): Change From Baseline to End of Study
Timepoint [35] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [36] 0 0
Homocysteine (Clinical Chemistry): Change From Baseline to End of Study
Timepoint [36] 0 0
Baseline, Weeks 6, 26, and 52
Primary outcome [37] 0 0
Vitamin B6 (Clinical Chemistry): Change From Baseline to End of Study
Timepoint [37] 0 0
Baseline, Weeks 6, 26, and 52
Primary outcome [38] 0 0
Vitamin B12 (Clinical Chemistry): Change From Baseline to End of Study
Timepoint [38] 0 0
Baseline, Weeks 6, 26, and 52
Primary outcome [39] 0 0
pH (Urinalysis): Change From Baseline to End of Study
Timepoint [39] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [40] 0 0
Specific Gravity (Urinalysis): Change From Baseline to End of Study
Timepoint [40] 0 0
Baseline, Weeks 6, 26, 39, and 52
Primary outcome [41] 0 0
Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Timepoint [41] 0 0
Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)
Primary outcome [42] 0 0
Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Timepoint [42] 0 0
Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)
Primary outcome [43] 0 0
Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study
Timepoint [43] 0 0
Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)
Primary outcome [44] 0 0
Electrocardiogram (ECG) Mean Heart Rate: Change From Baseline to End of Study
Timepoint [44] 0 0
Baseline, Day 1 (postdose), Weeks 6 and 52
Primary outcome [45] 0 0
Electrocardiogram (ECG) Aggregate PR Interval: Change From Baseline to End of Study
Timepoint [45] 0 0
Baseline, Day 1 (postdose), Weeks 6 and 52
Primary outcome [46] 0 0
Electrocardiogram (ECG) Aggregate QRS Duration: Change From Baseline to End of Study
Timepoint [46] 0 0
Baseline, Day 1 (postdose), Weeks 6 and 52
Primary outcome [47] 0 0
Electrocardiogram (ECG) Aggregate QT Interval: Change From Baseline to End of Study
Timepoint [47] 0 0
Baseline, Day 1 (postdose), Weeks 6 and 52
Primary outcome [48] 0 0
Electrocardiogram (ECG) Aggregate QTcB Interval: Change From Baseline to End of Study
Timepoint [48] 0 0
Baseline, Day 1 (postdose), Weeks 6 and 52
Primary outcome [49] 0 0
Electrocardiogram (ECG) Aggregate QTcF Interval: Change From Baseline to End of Study
Timepoint [49] 0 0
Baseline, Day 1 (postdose), Weeks 6 and 52
Primary outcome [50] 0 0
Electrocardiogram (ECG) Aggregate RR Interval: Change From Baseline to End of Study
Timepoint [50] 0 0
Baseline, Day 1 (postdose), Weeks 6 and 52
Secondary outcome [1] 0 0
Average Daily Normalized "Off" Time: Change From Baseline to End of Study
Timepoint [1] 0 0
Baseline, Weeks 1, 6, 13, 26, 39, and 52
Secondary outcome [2] 0 0
Average Daily Normalized "On" Time With Troublesome Dyskinesia: Change From Baseline to End of Study
Timepoint [2] 0 0
Baseline, Weeks 1, 6, 13, 26, 39, and 52
Secondary outcome [3] 0 0
Average Daily Normalized "On" Time Without Troublesome Dyskinesia: Change From Baseline to End of Study
Timepoint [3] 0 0
Baseline, Weeks 1, 6, 13, 26, 39, and 52
Secondary outcome [4] 0 0
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study
Timepoint [4] 0 0
Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52
Secondary outcome [5] 0 0
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study
Timepoint [5] 0 0
Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52
Secondary outcome [6] 0 0
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study
Timepoint [6] 0 0
Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52
Secondary outcome [7] 0 0
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study
Timepoint [7] 0 0
Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52
Secondary outcome [8] 0 0
Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study
Timepoint [8] 0 0
Baseline, Weeks 6, 13, 26, 39, and 52
Secondary outcome [9] 0 0
Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study
Timepoint [9] 0 0
Baseline, Weeks 6, 13, 26, 39, and 52
Secondary outcome [10] 0 0
The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study
Timepoint [10] 0 0
Baseline, Weeks 6, 13, 26, 39, and 52

Eligibility
Key inclusion criteria
* Participants with diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa-responsive
* Participants must be judged by the investigator to be inadequately controlled by current therapy, have recognizable/identifiable "Off" and "On" states (motor fluctuations), and have a minimum of 2.5 hours of "Off" time per day
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participant is cognitively impaired and is not able to safely and effectively manage the drug delivery system and the diaries and is not able to adhere to the study
* Participant is considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/08/2022
Sample size
Target
Accrual to date
Final
244
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital /ID# 207628 - Concord
Recruitment hospital [2] 0 0
Westmead Hospital /ID# 207633 - Westmead
Recruitment hospital [3] 0 0
Royal Adelaide Hospital /ID# 207634 - Adelaide
Recruitment hospital [4] 0 0
Alfred Health /ID# 207632 - Melbourne
Recruitment hospital [5] 0 0
Perron Institute /ID# 207627 - Nedlands
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
New Hampshire
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
United States of America
State/province [19] 0 0
Wisconsin
Country [20] 0 0
Belgium
State/province [20] 0 0
Vlaams-Brabant
Country [21] 0 0
Belgium
State/province [21] 0 0
Brugge
Country [22] 0 0
Belgium
State/province [22] 0 0
Liege
Country [23] 0 0
Canada
State/province [23] 0 0
Alberta
Country [24] 0 0
Canada
State/province [24] 0 0
Quebec
Country [25] 0 0
Denmark
State/province [25] 0 0
Hovedstaden
Country [26] 0 0
Denmark
State/province [26] 0 0
Midtjylland
Country [27] 0 0
Denmark
State/province [27] 0 0
Syddanmark
Country [28] 0 0
Germany
State/province [28] 0 0
Baden-Wuerttemberg
Country [29] 0 0
Germany
State/province [29] 0 0
Beelitz-Heilstaetten
Country [30] 0 0
Germany
State/province [30] 0 0
Haag
Country [31] 0 0
Italy
State/province [31] 0 0
Messina
Country [32] 0 0
Italy
State/province [32] 0 0
Milan
Country [33] 0 0
Italy
State/province [33] 0 0
Padova
Country [34] 0 0
Japan
State/province [34] 0 0
Hokkaido
Country [35] 0 0
Japan
State/province [35] 0 0
Kyoto
Country [36] 0 0
Japan
State/province [36] 0 0
Osaka
Country [37] 0 0
Japan
State/province [37] 0 0
Tokyo
Country [38] 0 0
Netherlands
State/province [38] 0 0
Zuid-Holland
Country [39] 0 0
Netherlands
State/province [39] 0 0
Nieuwegein
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Sankt-Peterburg
Country [41] 0 0
Spain
State/province [41] 0 0
Alicante
Country [42] 0 0
Spain
State/province [42] 0 0
Barcelona
Country [43] 0 0
Spain
State/province [43] 0 0
A Coruna
Country [44] 0 0
Spain
State/province [44] 0 0
Granada
Country [45] 0 0
Spain
State/province [45] 0 0
Madrid
Country [46] 0 0
Spain
State/province [46] 0 0
Sevilla
Country [47] 0 0
Sweden
State/province [47] 0 0
Skane Lan
Country [48] 0 0
Sweden
State/province [48] 0 0
Stockholms Lan
Country [49] 0 0
Sweden
State/province [49] 0 0
Vastra Gotalands Lan
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Scotland
Country [51] 0 0
United Kingdom
State/province [51] 0 0
London
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Plymouth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Available to whom?
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/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03781167