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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04379050
Ethics application status
Date submitted
1/05/2020
Date registered
7/05/2020
Date last updated
18/06/2024

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 up to 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)
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
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
Timepoint [3] 0 0
Up To Week 96
Primary outcome [4] 0 0
Change in Clinical Laboratory Test Data
Timepoint [4] 0 0
Up To Week 96
Primary outcome [5] 0 0
Change in Vital Signs Measurements
Timepoint [5] 0 0
Up To Week 96
Primary outcome [6] 0 0
Change From Baseline in Electrocardiograms (ECGs)
Timepoint [6] 0 0
Up To Week 96
Secondary outcome [1] 0 0
Average Normalized Daily "Off" Time
Timepoint [1] 0 0
Up To Week 96
Secondary outcome [2] 0 0
Average Normalized Daily "On" Time
Timepoint [2] 0 0
Up To Week 96
Secondary outcome [3] 0 0
Parkinson's Disease (PD) Symptoms Measurement
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)
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)
Timepoint [5] 0 0
Up To Week 96
Secondary outcome [6] 0 0
Cognitive Impairment Measurement
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
Sex
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
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
8/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2026
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital /ID# 215943 - Concord
Recruitment hospital [2] 0 0
Westmead Hospital /ID# 215941 - Westmead
Recruitment hospital [3] 0 0
Royal Adelaide Hospital /ID# 215940 - Adelaide
Recruitment hospital [4] 0 0
The Alfred Hospital /ID# 215942 - Melbourne
Recruitment hospital [5] 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
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 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
Vlaams-Brabant
Country [14] 0 0
Belgium
State/province [14] 0 0
Brugge
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
Germany
State/province [21] 0 0
Baden-Wuerttemberg
Country [22] 0 0
Germany
State/province [22] 0 0
Bayern
Country [23] 0 0
Germany
State/province [23] 0 0
Beelitz-Heilstaetten
Country [24] 0 0
Italy
State/province [24] 0 0
Messina
Country [25] 0 0
Italy
State/province [25] 0 0
Padova
Country [26] 0 0
Japan
State/province [26] 0 0
Hokkaido
Country [27] 0 0
Japan
State/province [27] 0 0
Osaka
Country [28] 0 0
Japan
State/province [28] 0 0
Tokyo
Country [29] 0 0
Netherlands
State/province [29] 0 0
Nieuwegein
Country [30] 0 0
Russian Federation
State/province [30] 0 0
Sankt-Peterburg
Country [31] 0 0
Spain
State/province [31] 0 0
A Coruna
Country [32] 0 0
Spain
State/province [32] 0 0
Alicante
Country [33] 0 0
Spain
State/province [33] 0 0
Barcelona
Country [34] 0 0
Spain
State/province [34] 0 0
Granada
Country [35] 0 0
Spain
State/province [35] 0 0
Sevilla
Country [36] 0 0
Sweden
State/province [36] 0 0
Skane Lan
Country [37] 0 0
Sweden
State/province [37] 0 0
Stockholms Lan
Country [38] 0 0
Sweden
State/province [38] 0 0
Vastra Gotalands Lan
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Devon
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Scotland
Country [41] 0 0
United Kingdom
State/province [41] 0 0
London

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 during the Primary Treatment Period and during the optional Extended Treatment Period.

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/study/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/study/NCT04379050