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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04750226




Registration number
NCT04750226
Ethics application status
Date submitted
10/02/2021
Date registered
11/02/2021

Titles & IDs
Public title
Study To Assess Adverse Events and Change in Disease Activity Of 24-hour Continuous Subcutaneous Infusion Of ABBV-951 In Adult Participants With Advanced Parkinson's Disease
Scientific title
An Open-Label Extension of Studies M15-736 and M20-339 to Evaluate the Safety and Tolerability of 24-Hour Daily Exposure of ABBV-951 in Subjects With Advanced Parkinson's Disease
Secondary ID [1] 0 0
2019-004204-35
Secondary ID [2] 0 0
M20-098
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 96 weeks during the Primary Treatment Period and during the optional Extended Treatment Period.


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
Percentage of Participants with Adverse Event (AEs)
Timepoint [1] 0 0
Up to Week 96
Primary outcome [2] 0 0
Percentage of Participants with AEs of Special Interest (AESIs)
Timepoint [2] 0 0
Up to Week 96
Primary outcome [3] 0 0
Percentage Of Participants With Numeric Grade Equal To Or Higher Than 5 On The Infusion Site Evaluation Scale
Timepoint [3] 0 0
Up To Week 96
Primary outcome [4] 0 0
Percentage Of Participants With Letter Grade Equal To Or Higher Than D On The Infusion Site Evaluation Scale
Timepoint [4] 0 0
Up To Week 96
Primary outcome [5] 0 0
Change From Baseline in Suicidality as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Timepoint [5] 0 0
Up To Week 96
Primary outcome [6] 0 0
Change From Baseline in Impulsive-Compulsive Disorders and related behaviors as assessed in Parkinson's Disease- Rating Scale (QUIP-RS)
Timepoint [6] 0 0
Up To Week 96
Primary outcome [7] 0 0
Change From Baseline in Cognitive Impairment as Assessed by the Mini-Mental State Examination (MMSE)
Timepoint [7] 0 0
Up To Week 96
Primary outcome [8] 0 0
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed.
Timepoint [8] 0 0
Up to Week 96
Primary outcome [9] 0 0
Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements like Systolic and Diastolic Blood Pressure will be Assessed
Timepoint [9] 0 0
Up to Week 96
Primary outcome [10] 0 0
Change From Baseline in Electrocardiograms (ECGs)
Timepoint [10] 0 0
Up to Week 96
Secondary outcome [1] 0 0
Change From Baseline in Average Normalized "On" Time as Assessed by the Parkinson's Disease (PD) Diary
Timepoint [1] 0 0
Up To Week 96
Secondary outcome [2] 0 0
Change From Baseline in Average Daily Normalized "Off" Time as Assessed by the PD Diary
Timepoint [2] 0 0
Up To Week 96
Secondary outcome [3] 0 0
Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part I
Timepoint [3] 0 0
Up To Week 96
Secondary outcome [4] 0 0
Change From Baseline in Motor Experiences of Daily Living
Timepoint [4] 0 0
Up To Week 96
Secondary outcome [5] 0 0
Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part III
Timepoint [5] 0 0
Up To Week 96
Secondary outcome [6] 0 0
Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part IV
Timepoint [6] 0 0
Up To Week 96
Secondary outcome [7] 0 0
Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Parts I-III
Timepoint [7] 0 0
Up To Week 96
Secondary outcome [8] 0 0
Change From Baseline in Sleep Symptoms
Timepoint [8] 0 0
Up To Week 96
Secondary outcome [9] 0 0
Change From Baseline in Quality Of Life as Assessed by the PD Questionnaire-39 item (PDQ-39)
Timepoint [9] 0 0
Up To Week 96
Secondary outcome [10] 0 0
Change From Baseline in Health-related Quality of Life as Assessed by EQ-5D-5L
Timepoint [10] 0 0
Up To Week 96
Secondary outcome [11] 0 0
Percentage Of Participants With Early Morning "Off" Assessed by the PD Diary as Percentage of Participants with early morning "Off" Upon Waking Up
Timepoint [11] 0 0
Up To Week 96

Eligibility
Key inclusion criteria
- Completion of the parent study, Study M15-736 or Study M20-339.
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participant 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
Not applicable
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2026
Actual
Sample size
Target
Accrual to date
Final
118
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Liverpool Hospital /ID# 221693 - Liverpool
Recruitment hospital [2] 0 0
Westmead Hospital /ID# 218418 - Westmead
Recruitment hospital [3] 0 0
Gold coast University Hospital /ID# 221694 - SouthPort
Recruitment hospital [4] 0 0
Royal Adelaide Hospital /ID# 218417 - Adelaide
Recruitment hospital [5] 0 0
The Royal Melbourne Hospital /ID# 218419 - 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
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
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
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
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
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Utah
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
United States of America
State/province [23] 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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04750226