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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03781167
Ethics application status
Date submitted
18/12/2018
Date registered
19/12/2018
Date last updated
20/08/2019

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 - Participants will receive ABBV-951 by continuous subcutaneous infusion (CSCI) for 52 weeks.


Treatment: Drugs: ABBV-951
solution for infusion

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse Events - Treatment emergent adverse events defined as any adverse event from the initiation of CSCI through 30 days after last infusion device is removed
Timepoint [1] 0 0
From initiation of CSCI through 30 days after last infusion device is removed (up to 56 weeks)
Primary outcome [2] 0 0
Adverse Events of Special Interest - Treatment emergent adverse events of special interest defined as any adverse event of polyneuropathy or weight loss from the initiation of CSCI through 30 days after last infusion device is removed
Timepoint [2] 0 0
From initiation of CSCI through 30 days after last infusion device is removed (up to 56 weeks)
Primary outcome [3] 0 0
Percentage of subjects 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 - The Infusion Site Evaluation Scale will be used to assess infusion sites.
Timepoint [3] 0 0
up to 56 weeks
Primary outcome [4] 0 0
Hematocrit (Hematology): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [4] 0 0
up to 56 weeks
Primary outcome [5] 0 0
Hemoglobin (Hematology): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [5] 0 0
up to 56 weeks
Primary outcome [6] 0 0
Red Blood Cell (RBC) Count (Hematology): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [6] 0 0
up to 56 weeks
Primary outcome [7] 0 0
White blood cell (WBC) count (Hematology): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [7] 0 0
up to 56 weeks
Primary outcome [8] 0 0
Neutrophils (Hematology): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [8] 0 0
up to 56 weeks
Primary outcome [9] 0 0
Lymphocytes (Hematology): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [9] 0 0
up to 56 weeks
Primary outcome [10] 0 0
Monocytes (Hematology): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [10] 0 0
up to 56 weeks
Primary outcome [11] 0 0
Absolute platelet count (Hematology): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [11] 0 0
up to 56 weeks
Primary outcome [12] 0 0
Mean corpuscular hemoglobin (Hematology): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [12] 0 0
up to 56 weeks
Primary outcome [13] 0 0
Mean corpuscular volume concentration (MCHC) (Hematology): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [13] 0 0
up to 56 weeks
Primary outcome [14] 0 0
Prothrombin time (PT) (Hematology): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [14] 0 0
up to 56 weeks
Primary outcome [15] 0 0
Activated partial thromboplastin time (Hematology): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [15] 0 0
up to 56 weeks
Primary outcome [16] 0 0
Blood urea nitrogen (BUN) (Clinical Chemistry): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [16] 0 0
up to 56 weeks
Primary outcome [17] 0 0
Creatinine (Clinical Chemistry): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [17] 0 0
up to 56 weeks
Primary outcome [18] 0 0
Creatine phosphokinase (Clinical Chemistry): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [18] 0 0
up to 56 weeks
Primary outcome [19] 0 0
Total bilirubin (Clinical Chemistry): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [19] 0 0
up to 56 weeks
Primary outcome [20] 0 0
Serum glutamic pyruvic transaminase (Clinical Chemistry): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [20] 0 0
up to 56 weeks
Primary outcome [21] 0 0
Serum glutamic-oxaloacetic transaminase (Clinical Chemistry): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [21] 0 0
up to 56 weeks
Primary outcome [22] 0 0
Lactate dehydrogenase (LDH) (Clinical Chemistry): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [22] 0 0
up to 56 weeks
Primary outcome [23] 0 0
Gamma-glutamyl transpeptidase (Clinical Chemistry): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [23] 0 0
up to 56 weeks
Primary outcome [24] 0 0
Alkaline phosphatase (Clinical Chemistry): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [24] 0 0
up to 56 weeks
Primary outcome [25] 0 0
Sodium (Clinical Chemistry): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [25] 0 0
up to 56 weeks
Primary outcome [26] 0 0
Potassium (Clinical Chemistry): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [26] 0 0
up to 56 weeks
Primary outcome [27] 0 0
Calcium (Clinical Chemistry): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [27] 0 0
up to 56 weeks
Primary outcome [28] 0 0
Inorganic phosphorus (Clinical Chemistry): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [28] 0 0
up to 56 weeks
Primary outcome [29] 0 0
Uric acid (Clinical Chemistry): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [29] 0 0
up to 56 weeks
Primary outcome [30] 0 0
Cholesterol (Clinical Chemistry): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [30] 0 0
up to 56 weeks
Primary outcome [31] 0 0
Albumin (Clinical Chemistry): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [31] 0 0
up to 56 weeks
Primary outcome [32] 0 0
Glucose (Clinical Chemistry): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [32] 0 0
up to 56 weeks
Primary outcome [33] 0 0
Sodium bicarbonate/CO2 (Clinical Chemistry): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [33] 0 0
up to 56 weeks
Primary outcome [34] 0 0
Magnesium (Clinical Chemistry): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [34] 0 0
up to 56 weeks
Primary outcome [35] 0 0
Creatinine clearance (Clinical Chemistry): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [35] 0 0
up to 56 weeks
Primary outcome [36] 0 0
Vitamin B6 (Clinical Chemistry): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [36] 0 0
up to 56 weeks
Primary outcome [37] 0 0
Vitamin B12 (Clinical Chemistry): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [37] 0 0
up to 56 weeks
Primary outcome [38] 0 0
Homocysteine (Clinical Chemistry): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [38] 0 0
up to 56 weeks
Primary outcome [39] 0 0
Specific gravity (Urinalysis): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [39] 0 0
up to 56 weeks
Primary outcome [40] 0 0
Ketones (Urinalysis): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [40] 0 0
up to 56 weeks
Primary outcome [41] 0 0
pH (Urinalysis): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [41] 0 0
up to 56 weeks
Primary outcome [42] 0 0
Protein (Urinalysis): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [42] 0 0
up to 56 weeks
Primary outcome [43] 0 0
Glucose (Urinalysis): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [43] 0 0
up to 56 weeks
Primary outcome [44] 0 0
Blood (Urinalysis): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [44] 0 0
up to 56 weeks
Primary outcome [45] 0 0
Bilirubin (Urinalysis): Change from Baseline to end of study - The change from baseline to end of study will be assessed for clinical laboratory tests.
Timepoint [45] 0 0
up to 56 weeks
Primary outcome [46] 0 0
Blood pressure (Vital Signs): Change from Baseline to end of study - The change from baseline to end of study will be assessed for vital signs.
Timepoint [46] 0 0
up to 56 weeks
Primary outcome [47] 0 0
Pulse rate (Vital Signs): Change from Baseline to end of study - The change from baseline to end of study will be assessed for vital signs.
Timepoint [47] 0 0
up to 56 weeks
Primary outcome [48] 0 0
Percentage of Participants with Abnormal Electrocardiogram (ECG) Results - ECG recordings will be evaluated as 'normal' or 'abnormal'.
Timepoint [48] 0 0
up to 56 weeks
Secondary outcome [1] 0 0
Average normalized daily "Off" time and "On" times: Change from Baseline to end of study - Average normalized daily "Off" time and "On" times as assessed by the Parkinson's Disease (PD) Diary.
Timepoint [1] 0 0
up to 56 weeks
Secondary outcome [2] 0 0
Parkinson's Disease (PD) symptoms: Change from Baseline to end of study - PD symptoms will be assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS- UPDRS) Parts I-IV (or the Unified Parkinson's Disease Rating Scale [UPDRS] Parts I-V where a validated translation of the MDS-UPDRS is not available).
Timepoint [2] 0 0
up to 56 weeks
Secondary outcome [3] 0 0
Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39): Change from Baseline to end of study - The PDQ-39 is used to measure aspects of health that are relevant to subjects with PD, and which may not be included in general health status questionnaires.
Timepoint [3] 0 0
up to 56 weeks
Secondary outcome [4] 0 0
Sleep symptoms as assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2): Change from Baseline to end of study - The PDSS-2 is used to characterize the various aspects of nocturnal sleep problems in patients with PD.
Timepoint [4] 0 0
up to 56 weeks
Secondary outcome [5] 0 0
Quality of Life Assessed by EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Index Score: Change from Baseline to End of Study - The EQ-5D-5L is a standardized instrument used to measure health-related quality of life that can be used in a wide range of health conditions and treatments.
Timepoint [5] 0 0
up to 56 weeks

Eligibility
Key inclusion criteria
- Subjects with diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa
-responsive

- Subjects 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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject 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

- Subject 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
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation & Gen Hos /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 Hospital /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
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Hampshire
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
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
Liege
Country [21] 0 0
Belgium
State/province [21] 0 0
Brugge
Country [22] 0 0
Belgium
State/province [22] 0 0
Leuven
Country [23] 0 0
Canada
State/province [23] 0 0
Alberta
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
Canada
State/province [25] 0 0
Quebec
Country [26] 0 0
Denmark
State/province [26] 0 0
Hovedstaden
Country [27] 0 0
Denmark
State/province [27] 0 0
Midtjylland
Country [28] 0 0
Denmark
State/province [28] 0 0
Syddanmark
Country [29] 0 0
France
State/province [29] 0 0
Haute-Garonne
Country [30] 0 0
France
State/province [30] 0 0
Provence-Alpes-Cote-d Azur
Country [31] 0 0
France
State/province [31] 0 0
Bron
Country [32] 0 0
Germany
State/province [32] 0 0
Thueringen
Country [33] 0 0
Germany
State/province [33] 0 0
Beelitz-heilstaetten
Country [34] 0 0
Germany
State/province [34] 0 0
Haag
Country [35] 0 0
Italy
State/province [35] 0 0
Messina
Country [36] 0 0
Italy
State/province [36] 0 0
Milan
Country [37] 0 0
Italy
State/province [37] 0 0
Padua
Country [38] 0 0
Japan
State/province [38] 0 0
Hokkaido
Country [39] 0 0
Japan
State/province [39] 0 0
Kyoto
Country [40] 0 0
Japan
State/province [40] 0 0
Osaka
Country [41] 0 0
Japan
State/province [41] 0 0
Tokyo
Country [42] 0 0
Netherlands
State/province [42] 0 0
Nieuwegein
Country [43] 0 0
Netherlands
State/province [43] 0 0
Rotterdam
Country [44] 0 0
Netherlands
State/province [44] 0 0
S Hertogenbosch
Country [45] 0 0
Spain
State/province [45] 0 0
Barcelona
Country [46] 0 0
Spain
State/province [46] 0 0
A Coruna
Country [47] 0 0
Spain
State/province [47] 0 0
Elche
Country [48] 0 0
Spain
State/province [48] 0 0
Granada
Country [49] 0 0
Spain
State/province [49] 0 0
Madrid
Country [50] 0 0
Spain
State/province [50] 0 0
Sevilla
Country [51] 0 0
Sweden
State/province [51] 0 0
Skane Lan
Country [52] 0 0
Sweden
State/province [52] 0 0
Vastra Gotalands Lan
Country [53] 0 0
Sweden
State/province [53] 0 0
Stockholm
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Scotland
Country [55] 0 0
United Kingdom
State/province [55] 0 0
London
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Plymouth

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the safety and tolerability of ABBV-951 in subjects
with Parkinson's disease (PD).
Trial website
https://clinicaltrials.gov/show/NCT03781167
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
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
847.283.8955
Fax 0 0
Email 0 0
abbvieclinicaltrials@abbvie.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03781167