COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted/resubmitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04379050




Registration number
NCT04379050
Ethics application status
Date submitted
1/05/2020
Date registered
7/05/2020
Date last updated
2/06/2020

Titles & IDs
Public title
Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's Disease
Scientific title
An Open-label Extension of Study M15-741 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
2019-004235-23
Secondary ID [2] 0 0
M15-737
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 solution by continuous subcutaneous infusion (CSCI), at the discretion of the investigator, for 96 weeks.


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 Events (AE) - An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of the study drug or device as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Adverse Events of Special Interest (AESI) - polyneuropathy, weight loss, hallucinations/psychosis, and somnolence will be monitored throughout the study.
Timepoint [1] 0 0
Up To Week 96
Primary outcome [2] 0 0
Percentage Of Participants With Numeric Grade Equal To Or Higher Than 5 On The Infusion Site Evaluation Scale - The Infusion Site Evaluation Scale will be used to assess infusion sites. Infusion Site Evaluation Scale is an eight-point numeric scale used to assess irritation at the infusion site area (0 being "no evidence of irritation" and 7 being "strong reaction spreading beyond the test site").
Timepoint [2] 0 0
Up To Week 96
Primary outcome [3] 0 0
Percentage Of Participants 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. Infusion Site Evaluation Scale is an A to G letter grade scale, used to assess irritation at the infusion site area (A being "no finding" to G being "Small petechial erosions and/or scabs").
Timepoint [3] 0 0
Up To Week 96
Primary outcome [4] 0 0
Change in Clinical Laboratory Test Data - Number of participants with clinically significant change from baseline in laboratory parameters (hematology, biochemistry, coagulation, and urinalysis) will be reported throughout the study.
Timepoint [4] 0 0
Up To Week 96
Primary outcome [5] 0 0
Change in Vital Signs Measurements - Number of participants with clinically significant change from baseline in vital signs will be reported throughout the study.
Timepoint [5] 0 0
Up To Week 96
Primary outcome [6] 0 0
Change From Baseline in Electrocardiograms (ECGs) - Change from baseline in 12-lead ECGs on heart rte, RR interval, PR interval, QRS duration, and QT interval will be monitored throughout the study.
Timepoint [6] 0 0
Up To Week 96
Secondary outcome [1] 0 0
Average Normalized Daily "Off" Time - Average normalized daily "Off" Time (Hours) is assessed based on Parkinson's Disease (PD) Diary.
Timepoint [1] 0 0
Up To Week 96
Secondary outcome [2] 0 0
Average Normalized Daily "On" Time - Average normalized daily "On" time is assessed based on Parkinson's Disease (PD) Diary.
Timepoint [2] 0 0
Up To Week 96
Secondary outcome [3] 0 0
Parkinson's Disease (PD) Symptoms Measurement - PD symptoms will be assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-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 [3] 0 0
Up To Week 96
Secondary outcome [4] 0 0
Change From Baseline in Quality Of Life Measurement as Assessed by PD Questionnaire-39 (PDQ-39) - Quality of life is assessed by the PD Questionnaire-39 items (PDQ-39). PDQ-39 is a disease-specific instrument designed to measure aspects of health that are relevant to participants with PD, and which may not be included in general health status questionnaires.
Each item is scored on a 5-point scale.
Timepoint [4] 0 0
Up To Week 96
Secondary outcome [5] 0 0
Change From Baseline in Health-related Quality Of Life Measurement as Assessed by EuroQol 5-dimensions questionnaire (EQ-5D-5L) - Health-related quality of life is assessed by the EuroQol 5-dimensions questionnaire (EQ-5D-5L).
EQ-5D-5L is a standardized instrument that consists of 2 parts: the EQ-5D descriptive system and the EQ visual analogue-scale (EQVAS).
Timepoint [5] 0 0
Up To Week 96
Secondary outcome [6] 0 0
Cognitive Impairment Measurement - Cognitive impairment is assessed by the Mini-Mental State Examination (MMSE). MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score of 0 to 30, with higher scores indicating better function.
Timepoint [6] 0 0
Up To Week 96

Eligibility
Key inclusion criteria
- Participants who have Parkinson's Disease and who have successfully completed the
parent study M15-741.

- Participants willing and able to comply with procedures required in the protocol.
Minimum age
30 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants, if judged by the investigator to be unsuitable candidates to continue to
receive ABBV-951 for any reason.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation & Gen Hos /ID# 215943 - Concord
Recruitment hospital [2] 0 0
Westmead Hospital /ID# 215941 - Westmead
Recruitment hospital [3] 0 0
Alfred Hospital /ID# 215942 - Melbourne
Recruitment hospital [4] 0 0
Perron Institute /ID# 215944 - Nedlands
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 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
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New Hampshire
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
Belgium
State/province [13] 0 0
Brugge
Country [14] 0 0
Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
Belgium
State/province [15] 0 0
Liege
Country [16] 0 0
Canada
State/province [16] 0 0
Alberta
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Denmark
State/province [18] 0 0
Hovedstaden
Country [19] 0 0
Denmark
State/province [19] 0 0
Midtjylland
Country [20] 0 0
Denmark
State/province [20] 0 0
Syddanmark
Country [21] 0 0
Italy
State/province [21] 0 0
Messina
Country [22] 0 0
Italy
State/province [22] 0 0
Milan
Country [23] 0 0
Italy
State/province [23] 0 0
Padua
Country [24] 0 0
Japan
State/province [24] 0 0
Hokkaido
Country [25] 0 0
Japan
State/province [25] 0 0
Osaka
Country [26] 0 0
Japan
State/province [26] 0 0
Tokyo
Country [27] 0 0
Netherlands
State/province [27] 0 0
Nieuwegein
Country [28] 0 0
Netherlands
State/province [28] 0 0
Rotterdam
Country [29] 0 0
Spain
State/province [29] 0 0
Barcelona
Country [30] 0 0
Spain
State/province [30] 0 0
A Coruna
Country [31] 0 0
Spain
State/province [31] 0 0
Elche
Country [32] 0 0
Spain
State/province [32] 0 0
Granada
Country [33] 0 0
Spain
State/province [33] 0 0
Madrid
Country [34] 0 0
Spain
State/province [34] 0 0
Sevilla
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Scotland
Country [36] 0 0
United Kingdom
State/province [36] 0 0
London
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Plymouth

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. The purpose of this study is to continue
testing whether ABBV-951 is safe, effective, and tolerable in participants with Parkinson's
disease after completion of the parent study M15-741.

ABBV-951 is an investigational (unapproved) drug containing levodopa phosphate/carbidopa
phosphate (LDP/CDP) given as infusion under the skin for the treatment of Parkinson's
Disease. Participants who have successfully completed M15-741 study will immediately enter
this study's treatment period to continue receiving ABBV-951. Adult participants with
advanced PD will be enrolled. Approximately 130 adult participants will be enrolled in the
study at approximately 65 sites worldwide.

Participants will receive continuous subcutaneous infusion (CSCI) of ABBV-951 for 24 hours
daily for 96 weeks or until premature discontinuation.

There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular clinic visits and have remote assessments
completed via phone calls during the course of the study. 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/NCT04379050
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04379050