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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04380142




Registration number
NCT04380142
Ethics application status
Date submitted
6/05/2020
Date registered
8/05/2020

Titles & IDs
Public title
Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations In Adult Participants With Advanced Parkinson's Disease
Scientific title
A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients
Secondary ID [1] 0 0
2019-003930-18
Secondary ID [2] 0 0
M15-736
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
Treatment: Drugs - Placebo for Levodopa/Carbidopa (LD/CD)
Treatment: Drugs - Levodopa/Carbidopa (LD/CD)
Treatment: Drugs - Placebo for ABBV-951

Experimental: ABBV-951 + Placebo for Levodopa/Carbidopa (LD/CD) - After an open-label LD/CD Stabilization Period, participants will receive double-blind ABBV-951 by continuous subcutaneous infusion (CSCI) and oral placebo for LD/CD for 12 weeks

Active comparator: Levodopa/Carbidopa (LD/CD) + Placebo for ABBV-951 - After an open-label LD/CD Stabilization Period, participants will receive double-blind oral LD/CD and CSCI of placebo for ABBV-951 for 12 weeks


Treatment: Drugs: ABBV-951
Solution for continuous subcutaneous infusion (CSCI)

Treatment: Drugs: Placebo for Levodopa/Carbidopa (LD/CD)
Oral capsule

Treatment: Drugs: Levodopa/Carbidopa (LD/CD)
Oral encapsulated tablet

Treatment: Drugs: Placebo for 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
Change From Baseline to Week 12 of the Double-Blind Treatment Period in Average Daily Normalized "On" Time Without Troublesome Dyskinesia
Timepoint [1] 0 0
Baseline (Week 0) up to Week 12 of the double-blind treatment period
Secondary outcome [1] 0 0
Change From Baseline to Week 12 of the Double-Blind Treatment Period in Average Daily Normalized "Off" Time (Hours)
Timepoint [1] 0 0
Baseline (Week 0) up to Week 12 of the double-blind treatment period
Secondary outcome [2] 0 0
Change From Baseline to Week 12 of the Double-Blind Treatment Period in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score
Timepoint [2] 0 0
Baseline (Week 0) up to Week 12 of the double-blind treatment period
Secondary outcome [3] 0 0
Early Morning "Off" Status (Morning Akinesia) at Week 12 of the Double-Blind Treatment Period
Timepoint [3] 0 0
Week 12 of the double-blind treatment period
Secondary outcome [4] 0 0
Change From Baseline to Week 12 of the Double-Blind Treatment Period in Average Daily Normalized "On" Time Without Dyskinesia (Hours)
Timepoint [4] 0 0
Baseline, Week 12 of the double-blind treatment period
Secondary outcome [5] 0 0
Change From Baseline to Week 12 of the Double-Blind Treatment Period in Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score
Timepoint [5] 0 0
Baseline (Week 0) up to Week 12 of the double-blind treatment period
Secondary outcome [6] 0 0
Change From Baseline to Week 12 of the Double-Blind Treatment Period in Quality of Life Assessed by Parkinson's Disease Questionnaire 39 Item (PDQ-39) Summary Index Score
Timepoint [6] 0 0
Baseline (Week 0) up to Week 12 of the double-blind treatment period
Secondary outcome [7] 0 0
Change From Baseline to Week 12 of the Double-Blind Treatment Period in Quality of Life Assessed by the EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Summary Index
Timepoint [7] 0 0
Baseline (Week 0) up to Week 12 of the double-blind treatment period
Secondary outcome [8] 0 0
Change From Baseline to Week 12 of the Double-Blind Treatment Period in Median Bradykinesia Score (BK50) as Assessed by the Parkinson's KinetiGraph/Personal KinetiGraph (PKG) Wearable Device
Timepoint [8] 0 0
Baseline (Week 0) up to Week 12 of the double-blind treatment period
Secondary outcome [9] 0 0
Change From Baseline to Week 12 of the Double-Blind Treatment Period in Interquartile Range of Bradykinesia Score (BK75-BK25) as Assessed by the PKG Wearable Device
Timepoint [9] 0 0
Baseline (Week 0) up to Week 12 of the double-blind treatment period
Secondary outcome [10] 0 0
Change From Baseline to Week 12 of the Double-Blind Treatment Period in Median Dyskinesia Score (DK50) as Assessed by the PKG Wearable Device
Timepoint [10] 0 0
Baseline (Week 0) up to Week 12 of the double-blind treatment period
Secondary outcome [11] 0 0
Change From Baseline to Week 12 of the Double-Blind Treatment Period in Interquartile Range of Dyskinesia Score (DK75-DK25) as Assessed by the PKG Wearable Device
Timepoint [11] 0 0
Baseline (Week 0) up to Week 12 of the double-blind treatment period
Secondary outcome [12] 0 0
Number of Participants With Irritation Grade Numeric Grade >= 5 or Letter Grade >= D on the Infusion Site Irritation Scale Across All Study Post-Baseline Visits
Timepoint [12] 0 0
Day 2 up to Week 12 of the double-blind treatment period plus 30 days
Secondary outcome [13] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the Oral LD/CD Stabilization Period
Timepoint [13] 0 0
From first dose of stabilization period treatment up to the first dose of the double-blind treatment period
Secondary outcome [14] 0 0
Number of Participants With TEAEs During the Double-Blind Treatment Period
Timepoint [14] 0 0
From first dose of double-blind treatment up to Week 12 of the double-blind treatment period plus 30 days
Secondary outcome [15] 0 0
Number of Participants With Potentially Clinically Significant Changes From Baseline in Hematology, Chemistry, Urinalysis, Special Laboratory Parameters, Vital Signs, and Electrocardiograms (ECGs)
Timepoint [15] 0 0
Screening up to Week 12 of the double-blind treatment period
Secondary outcome [16] 0 0
Number of Participants With Affirmative Responses on the Columbia-Suicide Severity Rating Scale (C-SSRS) Across All Study Post-Baseline Visits During the Double-Blind Treatment Period
Timepoint [16] 0 0
Screening up to Week 12 of the double-blind treatment period
Secondary outcome [17] 0 0
Number of Participants With a Subscore > 5 For Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Ration Scale (QUIP-RS) at Any Time During the Double-Blind Treatment Period
Timepoint [17] 0 0
Baseline (Week 0) up to Week 12 of the double-blind treatment period

Eligibility
Key inclusion criteria
* Diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa-responsive.
* Participant must be taking a minimum of 400 milligrams/day (mg/day) of Levodopa (LD) equivalents and be judged by the investigator to have motor symptoms inadequately controlled by current therapy, have a recognizable/identifiable "Off" and "On" states (motor fluctuations), and have an average "Off" time of at least 2.5 hours/day over 3 consecutive PD Diary days with a minimum of 2 hours each day.
* Participant or caregiver, if applicable, demonstrates the understanding and correct use of the delivery system, including the insertion of the cannula into the participant's abdomen, as assessed by the investigator or designee during the Screening period.
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Clinically significant, unstable medical conditions or any other reason that the investigator determines would interfere with the participant's participation in this study or would make the participant an unsuitable candidate to receive study drug.
* History of allergic reaction or significant sensitivity to LD or constituents of the study drug (and its excipients) and/or other products in the same class.
* Participant has not received deep brain stimulation, CD/LD enteral suspension, or any other PD medication as continuous daily infusion, whether commercially available or investigational. Previous exposure to ABBV-951 is not allowed.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
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
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,QLD,SA,VIC
Recruitment hospital [1] 0 0
Liverpool Hospital /ID# 218681 - Liverpool
Recruitment hospital [2] 0 0
Westmead Hospital /ID# 216535 - Westmead
Recruitment hospital [3] 0 0
Gold coast University Hospital /ID# 218373 - SouthPort
Recruitment hospital [4] 0 0
Royal Adelaide Hospital /ID# 216533 - Adelaide
Recruitment hospital [5] 0 0
Kingston Centre /ID# 216537 - Cheltenham
Recruitment hospital [6] 0 0
The Royal Melbourne Hospital /ID# 216536 - Parkville
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4215 - SouthPort
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3192 - Cheltenham
Recruitment postcode(s) [6] 0 0
3050 - Parkville
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
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Delaware
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
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State/province [18] 0 0
North Carolina
Country [19] 0 0
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State/province [19] 0 0
Ohio
Country [20] 0 0
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State/province [20] 0 0
Oklahoma
Country [21] 0 0
United States of America
State/province [21] 0 0
Oregon
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
South Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
Tennessee
Country [25] 0 0
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State/province [25] 0 0
Texas
Country [26] 0 0
United States of America
State/province [26] 0 0
Utah
Country [27] 0 0
United States of America
State/province [27] 0 0
Virginia
Country [28] 0 0
United States of America
State/province [28] 0 0
Washington
Country [29] 0 0
United States of America
State/province [29] 0 0
Wisconsin

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 and 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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing, please refer to the link below.
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 (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
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.