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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04380142
Ethics application status
Date submitted
6/05/2020
Date registered
8/05/2020
Date last updated
10/11/2020

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) - Participants will receive 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 - Participants will receive 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 in "On" Time (Hours) Without Troublesome Dyskinesia - "On" time without dyskinesia plus "On" time with non-troublesome dyskinesia are based on the Parkinson's Disease (PD) Diary (normalized to a 16-hour waking day averaged over 3 consecutive days). Baseline value is defined as the average of normalized "On" time without troublesome dyskinesia collected over the 3 PD Diary days before randomization.
Timepoint [1] 0 0
Baseline (Week 0) Up to Week 12
Secondary outcome [1] 0 0
Change in "Off" Time (Hours) - "Off" time is assessed by the PD Diary.
Timepoint [1] 0 0
Baseline (Week 0) Up to Week 12
Secondary outcome [2] 0 0
Change in Motor Experiences of Daily Living - Motor Experiences of Daily Living is assessed by Part II of Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The Part II MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD) with scores ranging from 0 to 52.
Timepoint [2] 0 0
Baseline (Week 0) Up to Week 12
Secondary outcome [3] 0 0
Change 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.
Timepoint [3] 0 0
Baseline (Week 0) Up to Week 12
Secondary outcome [4] 0 0
Change in Quality of Life Assessed by PD Questionnaire-39 item (PDQ-39) - PDQ-39 is a disease-specific instrument designed to measure aspects of health that are relevant to subjects with PD, and which may not be included in general health status questionnaires.
Timepoint [4] 0 0
Baseline (Week 0) Up to Week 12
Secondary outcome [5] 0 0
Early Morning "Off" Status - Early morning "Off" status is assessed by the PD Diary as percentage of participants with early morning "Off" upon waking up.
Timepoint [5] 0 0
At Week 12
Secondary outcome [6] 0 0
Change in Quality of Life Assessed by the EuroQol 5-Dimension Questionnaire (EQ-5D-5L) - EQ-5D-5L is a standardized instrument developed by the EuroQol Group as a measure of health related quality of life that can be used in a wide range of health conditions and treatments.
Timepoint [6] 0 0
Baseline (Week 0) Up to Week 12
Secondary outcome [7] 0 0
Change 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.
Timepoint [7] 0 0
Baseline (Week 0) Up to Week 12
Secondary outcome [8] 0 0
Change 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.
Timepoint [8] 0 0
Baseline (Week 0) Up to Week 12
Secondary outcome [9] 0 0
Change 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.
Timepoint [9] 0 0
Baseline (Week 0) Up to Week 12
Secondary outcome [10] 0 0
Change in PD Symptoms as Assessed by the MDS-UPDRS Tool Total Score of 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.
Timepoint [10] 0 0
Baseline (Week 0) Up to Week 12
Secondary outcome [11] 0 0
Change in PD Symptoms as Assessed by the Parkinson's KinetiGraph/Personal KinetiGraph (PKG) Wearable Device - PKG wearable device is an innovative mobile health technology that provides continuous, objective, ambulatory assessment of the symptoms of PD including tremor, bradykinesia, dyskinesia, and daytime somnolence.
Timepoint [11] 0 0
Baseline (Week 0) Up to Week 12

Eligibility
Key inclusion criteria
- Diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa-responsive.

- Participants 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
Gender
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.

- Has no known active Coronavirus Disease - 2019 (COVID-19) infection.

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
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,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
Alfred Hospital /ID# 216534 - Melbourne
Recruitment hospital [7] 0 0
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
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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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
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State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
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Delaware
Country [7] 0 0
United States of America
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District of Columbia
Country [8] 0 0
United States of America
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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
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Indiana
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Kansas
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Massachusetts
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Michigan
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Missouri
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Nebraska
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Washington
Country [30] 0 0
United States of America
State/province [30] 0 0
Wisconsin

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

Ethics approval
Ethics application status

Summary
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 measures the efficacy,
safety, and tolerability of ABBV-951 versus oral Levodopa (LD)/Carbidopa (CD) [LD/CD] in
advanced PD participants to achieve reduction in motor fluctuations.

ABBV-951 is an investigational (unapproved) drug containing Levodopa Phosphate/Carbidopa
Phosphate (LDP/CDP) given subcutaneously (under the skin) for the treatment of Parkinson's
Disease. The study has two treatment arms . In one arm, participants will be given ABBV-951
plus oral placebo (does not contain treatment drug). In the second arm, participants will be
given placebo solution and LD/CD tablets. Adult participants with advanced PD will be
enrolled. Approximately 130 participants will be enrolled in the study in approximately 80
sites across the world.

In one arm, participants will receive ABBV-951 solution as a continuous infusion under the
skin plus oral placebo capsules for LD/CD. In the second arm, participants will receive
placebo solution for ABBV-951 as a continuous infusion under the skin plus oral capsules
containing LD/CD tablets. The treatment duration is 12 weeks.

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 assessments, blood
tests, checking for side effects, and completing questionnaires.
Trial website
https://clinicaltrials.gov/show/NCT04380142
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/NCT04380142