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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Parkinson's Disease (PD)

Intervention / Treatment
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* Drug: ABBV-951


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Completion of the parent study, Study M15-736 or Study M20-339. Exclusion Criteria: - Participant considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABBV-951<br>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. | Drug: ABBV-951<br>* Solution for continuous subcutaneous infusion (CSCI).<br>* Other names: Foslevodopa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Adverse Event (AEs) | 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. | Up to Week 96 | 
| Percentage of Participants with AEs of Special Interest (AESIs) | 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. | Up to Week 96 | 
| 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). | Up To Week 96 | 
| 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). | Up To Week 96 | 
| Change From Baseline in Suicidality as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | 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. | Up To Week 96 | 
| Change From Baseline in Impulsive-Compulsive Disorders and related behaviors as assessed in Parkinson's Disease- Rating Scale (QUIP-RS) | 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. | Up To Week 96 | 
| Change From Baseline in Cognitive Impairment as Assessed by the Mini-Mental State Examination (MMSE) | 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. | Up To Week 96 | 
| Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed. | Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.. | Up to Week 96 | 
| Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements like Systolic and Diastolic Blood Pressure will be Assessed | Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed. | Up to Week 96 | 
| Change From Baseline in Electrocardiograms (ECGs) | 12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration. | Up to Week 96 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Average Normalized On Time as Assessed by the Parkinson's Disease (PD) Diary | Change in On time without dyskinesia or with non-troublesome dyskinesia as assessed by the PD diary. | Up To Week 96 | 
| Change From Baseline in Average Daily Normalized Off Time as Assessed by the PD Diary | Change in average daily normalized Off Time (Hours) is assessed based on PD Diary. | Up To Week 96 | 
| Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part I | 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. | Up To Week 96 | 
| Change From Baseline in Motor Experiences of Daily Living | 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. | Up To Week 96 | 
| Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part III | 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. | Up To Week 96 | 
| Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part 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. | Up To Week 96 | 
| Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Parts I-III | 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. | Up To Week 96 | 
| Change From Baseline in Sleep Symptoms | 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. | Up To Week 96 | 
| Change From Baseline in Quality Of Life as Assessed by the PD Questionnaire-39 item (PDQ-39) | 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. | Up To Week 96 | 
| Change From Baseline in Health-related Quality of Life as Assessed by EQ-5D-5L | 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). | Up To Week 96 | 
| Percentage Of Participants With Early Morning Off Assessed by the PD Diary as Percentage of Participants with early morning Off Upon Waking Up | Early morning Off status is assessed by the PD Diary as percentage of participants with early morning Off upon waking up. | Up To Week 96 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's Disease, PD, ABBV-951, Levodopa/Carbidopa (LD/CD), Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP)