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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
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
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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
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Secondary ID [1]
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2019-004235-23
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Secondary ID [2]
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M15-737
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease (PD)
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Condition category
Condition code
Neurological
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Parkinson's disease
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Intervention/exposure
Study type
Interventional
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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).
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Adverse Events (AE)
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Assessment method [1]
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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.
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Timepoint [1]
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Up To Week 96
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Primary outcome [2]
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Percentage Of Participants With Numeric Grade Equal To Or Higher Than 5 On The Infusion Site Evaluation Scale
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Assessment method [2]
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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").
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Timepoint [2]
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Up To Week 96
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Primary outcome [3]
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Percentage Of Participants With Letter Grade Equal To Or Higher Than D On The Infusion Site Evaluation Scale
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Assessment method [3]
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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").
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Timepoint [3]
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Up To Week 96
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Primary outcome [4]
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Change in Clinical Laboratory Test Data
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Assessment method [4]
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Number of participants with clinically significant change from baseline in laboratory parameters (hematology, biochemistry, coagulation, and urinalysis) will be reported throughout the study.
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Timepoint [4]
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Up To Week 96
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Primary outcome [5]
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Change in Vital Signs Measurements
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Assessment method [5]
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Number of participants with clinically significant change from baseline in vital signs will be reported throughout the study.
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Timepoint [5]
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Up To Week 96
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Primary outcome [6]
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Change From Baseline in Electrocardiograms (ECGs)
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Assessment method [6]
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Change from baseline in 12-lead ECGs on heart rate, RR interval, PR interval, QRS duration, and QT interval will be monitored throughout the study.
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Timepoint [6]
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Up To Week 96
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Secondary outcome [1]
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Average Normalized Daily "Off" Time
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Assessment method [1]
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Average normalized daily "Off" Time (Hours) is assessed based on Parkinson's Disease (PD) Diary.
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Timepoint [1]
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Up To Week 96
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Secondary outcome [2]
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Average Normalized Daily "On" Time
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Assessment method [2]
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Average normalized daily "On" time is assessed based on Parkinson's Disease (PD) Diary.
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Timepoint [2]
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Up To Week 96
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Secondary outcome [3]
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Parkinson's Disease (PD) Symptoms Measurement
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Assessment method [3]
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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.
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Timepoint [3]
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Up To Week 96
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Secondary outcome [4]
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Change From Baseline in Quality Of Life Measurement as Assessed by PD Questionnaire-39 (PDQ-39)
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Assessment method [4]
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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.
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Timepoint [4]
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Up To Week 96
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Secondary outcome [5]
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Change From Baseline in Health-related Quality Of Life Measurement as Assessed by EuroQol 5-dimensions questionnaire (EQ-5D-5L)
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Assessment method [5]
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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).
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Timepoint [5]
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Up To Week 96
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Secondary outcome [6]
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Cognitive Impairment Measurement
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Assessment method [6]
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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.
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Timepoint [6]
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Up To Week 96
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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.
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Minimum age
30
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Participants, if judged by the investigator to be unsuitable candidates to continue to receive ABBV-951 for any reason.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/06/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/04/2026
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Actual
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Sample size
Target
130
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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Concord Repatriation General Hospital /ID# 215943 - Concord
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Recruitment hospital [2]
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Westmead Hospital /ID# 215941 - Westmead
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Recruitment hospital [3]
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Royal Adelaide Hospital /ID# 215940 - Adelaide
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Recruitment hospital [4]
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The Alfred Hospital /ID# 215942 - Melbourne
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Recruitment hospital [5]
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Perron Institute /ID# 215944 - Nedlands
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Recruitment postcode(s) [1]
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2139 - Concord
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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3004 - Melbourne
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Recruitment postcode(s) [5]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Colorado
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Florida
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Kansas
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Missouri
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Hovedstaden
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Germany
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Messina
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Padova
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Hokkaido
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Osaka
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Japan
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Tokyo
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Nieuwegein
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Russian Federation
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Sankt-Peterburg
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A Coruna
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Spain
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Alicante
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Spain
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Barcelona
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Devon
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT04379050
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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)
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When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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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/
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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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/NCT04379050