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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 104
- 主要终点
- Change From Baseline in Impulsive-Compulsive Disorders and related behaviors as assessed in Parkinson's Disease- Rating Scale (QUIP-RS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Completion of the parent study, Study M15-736 or Study M20-339.
排除标准
- •- Participant considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason.
研究组 & 干预措施
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.
干预措施: ABBV-951 (Drug)
结局指标
主要结局
Change From Baseline in Impulsive-Compulsive Disorders and related behaviors as assessed in Parkinson's Disease- Rating Scale (QUIP-RS)
时间窗: Up To Week 96
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.
Percentage of Participants with Adverse Event (AEs)
时间窗: Up to Week 96
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.
Percentage of Participants with AEs of Special Interest (AESIs)
时间窗: Up to Week 96
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.
Percentage Of Participants With Letter Grade Equal To Or Higher Than D On The Infusion Site Evaluation Scale
时间窗: Up To Week 96
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").
Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements like Systolic and Diastolic Blood Pressure will be Assessed
时间窗: 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.
Change From Baseline in Electrocardiograms (ECGs)
时间窗: Up to Week 96
12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed.
时间窗: Up to Week 96
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed..
Percentage Of Participants With Numeric Grade Equal To Or Higher Than 5 On The Infusion Site Evaluation Scale
时间窗: Up To Week 96
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").
Change From Baseline in Suicidality as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
时间窗: Up To Week 96
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.
Change From Baseline in Cognitive Impairment as Assessed by the Mini-Mental State Examination (MMSE)
时间窗: Up To Week 96
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.
次要结局
- Change From Baseline in Motor Experiences of Daily Living(Up To Week 96)
- Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Parts I-III(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(Up To Week 96)
- Change From Baseline in Average Normalized "On" Time as Assessed by the Parkinson's Disease (PD) Diary(Up To Week 96)
- Change From Baseline in Average Daily Normalized "Off" Time as Assessed by the PD Diary(Up To Week 96)
- Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part I(Up To Week 96)
- Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part III(Up To Week 96)
- Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part IV(Up To Week 96)
- Change From Baseline in Sleep Symptoms(Up To Week 96)
- Change From Baseline in Quality Of Life as Assessed by the PD Questionnaire-39 item (PDQ-39)(Up To Week 96)
- Change From Baseline in Health-related Quality of Life as Assessed by EQ-5D-5L(Up To Week 96)