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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
Date last updated
18/06/2024
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
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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
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Secondary ID [1]
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2019-004204-35
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Secondary ID [2]
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M20-098
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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 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).
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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 Event (AEs)
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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 this treatment. An 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above.
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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 AEs of Special Interest (AESIs)
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Assessment method [2]
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AESIs are defined as AEs from "special situations," such as accidental or intentional overdose, medication error, occupational or accidental exposure, off-label use, drug abuse, drug misuse, or drug withdrawal, all which must be reported whether associated with an AE or not.
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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 Numeric Grade Equal To Or Higher Than 5 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 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 [3]
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Up To Week 96
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Primary outcome [4]
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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 [4]
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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 [4]
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Up To Week 96
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Primary outcome [5]
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Change From Baseline in Suicidality as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
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Assessment method [5]
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C-SSRS is a systematically administered instrument designed to assess suicidal behavior and ideation, track and assess all suicidal events, and assess the lethality of attempts. Any participant who has suicidal behavior or suicidal ideation with plan since the last C-SSRS completed, will be evaluated immediately by the investigator.
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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 Impulsive-Compulsive Disorders and related behaviors as assessed in Parkinson's Disease- Rating Scale (QUIP-RS)
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Assessment method [6]
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The QUIP-RS is a brief, self-completed or rater-administered rating scale to assess the severity of symptoms of impulse control disorders (ICDs) and related behaviors reported to occur in PD. The QUIP-RS uses a 5-point Likert scale that requires individuals to rate the severity of each symptom based on its frequency.
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Timepoint [6]
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Up To Week 96
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Primary outcome [7]
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Change From Baseline in Cognitive Impairment as Assessed by the Mini-Mental State Examination (MMSE)
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Assessment method [7]
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Cognitive impairment is assessed by the Mini-Mental State Examination (MMSE). MMSE is a brief 30-point questionnaire, administered by a trained rater, that provides a quantitative measure of cognitive status in adults and is used widely to screen for cognitive impairment and to estimate the severity of cognitive impairment at a given point in time, to follow the course of changes in a patient over time, and to document response to treatment.
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Timepoint [7]
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Up To Week 96
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Primary outcome [8]
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Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed.
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Assessment method [8]
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Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed..
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Timepoint [8]
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Up to Week 96
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Primary outcome [9]
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Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements like Systolic and Diastolic Blood Pressure will be Assessed
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Assessment method [9]
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Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
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Timepoint [9]
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Up to Week 96
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Primary outcome [10]
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Change From Baseline in Electrocardiograms (ECGs)
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Assessment method [10]
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12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.
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Timepoint [10]
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Up to Week 96
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Secondary outcome [1]
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Change From Baseline in Average Normalized "On" Time as Assessed by the Parkinson's Disease (PD) Diary
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Assessment method [1]
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Change in "On" time without dyskinesia or with non-troublesome dyskinesia as assessed by the 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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Change From Baseline in Average Daily Normalized "Off" Time as Assessed by the PD Diary
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Assessment method [2]
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Change in average daily normalized "Off" Time (Hours) is assessed based on 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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Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part I
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Assessment method [3]
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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 Motor Experiences of Daily Living
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Assessment method [4]
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Motor experiences of daily living is assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II. 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 [4]
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Up To Week 96
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Secondary outcome [5]
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Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part III
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Assessment method [5]
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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 [5]
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Up To Week 96
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Secondary outcome [6]
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Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part IV
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Assessment method [6]
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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 [6]
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Up To Week 96
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Secondary outcome [7]
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Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Parts I-III
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Assessment method [7]
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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 [7]
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Up To Week 96
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Secondary outcome [8]
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Change From Baseline in Sleep Symptoms
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Assessment method [8]
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Sleep symptoms are assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2). The PDSS-2 consists of 15 questions that evaluate motor and non-motor symptoms at night and upon wakening, as well as disturbed sleep.
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Timepoint [8]
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Up To Week 96
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Secondary outcome [9]
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Change From Baseline in Quality Of Life as Assessed by the PD Questionnaire-39 item (PDQ-39)
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Assessment method [9]
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Quality of life is assessed by the PD Questionnaire-39 item (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 [9]
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Up To Week 96
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Secondary outcome [10]
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Change From Baseline in Health-related Quality of Life as Assessed by EQ-5D-5L
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Assessment method [10]
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Health-related quality of life is assessed by 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 (EQ-VAS).
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Timepoint [10]
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Up To Week 96
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Secondary outcome [11]
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Percentage Of Participants With Early Morning "Off" Assessed by the PD Diary as Percentage of Participants with early morning "Off" Upon Waking Up
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Assessment method [11]
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Early morning "Off" status is assessed by the PD Diary as percentage of participants with early morning "Off" upon waking up.
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Timepoint [11]
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Up To Week 96
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Eligibility
Key inclusion criteria
- Completion of the parent study, Study M15-736 or Study M20-339.
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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
- Participant considered by the investigator to be an unsuitable candidate 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
18/02/2021
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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
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Accrual to date
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Final
118
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Liverpool Hospital /ID# 221693 - Liverpool
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Recruitment hospital [2]
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Westmead Hospital /ID# 218418 - Westmead
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Recruitment hospital [3]
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Gold coast University Hospital /ID# 221694 - SouthPort
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Recruitment hospital [4]
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Royal Adelaide Hospital /ID# 218417 - Adelaide
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Recruitment hospital [5]
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The Royal Melbourne Hospital /ID# 218419 - Parkville
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Recruitment postcode(s) [1]
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2170 - Liverpool
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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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4215 - SouthPort
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Recruitment postcode(s) [4]
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5000 - Adelaide
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Recruitment postcode(s) [5]
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3050 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
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Arizona
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California
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United States of America
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Colorado
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United States of America
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State/province [5]
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District of Columbia
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Florida
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State/province [7]
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Illinois
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Massachusetts
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Missouri
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New Jersey
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New York
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Country [12]
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North Carolina
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Ohio
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Country [14]
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Oklahoma
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Oregon
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Pennsylvania
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United States of America
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South Carolina
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State/province [18]
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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United States of America
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State/province [23]
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Wisconsin
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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. This study will assess how safe and effective ABBV-951 is in adult participants with PD. Adverse events and change in disease activity is evaluated.
ABBV-951 is an investigational (unapproved) drug containing Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP) given as an infusion under the skin for the treatment of Parkinson's Disease. Adult participants with advanced PD and who have completed M15-736 or M20-339 study will be enrolled. Approximately 130 participants will be enrolled in the study in approximately 60 sites in the United States and Australia.
Participants will receive continuous subcutaneous infusion (CSCI) (under the skin) of ABBV-951 for 96 weeks 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 visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical and remote telephone assessments, blood tests, checking for side effects, and completing questionnaires.
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Trial website
https://clinicaltrials.gov/study/NCT04750226
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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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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT04750226
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