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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
NA
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
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.

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 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?

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