NCT04292223已完成4 期
A 16-Week Open-Label Study of the Effects of Treatment With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease Psychosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 18
- 主要终点
- Change From Baseline to Week 16 in Modified Functional Status Questionnaire (mFSQ) Total Score
研究概览
简要总结
To assess the effect of pimavanserin on the activities of daily living in subjects with Parkinson's Disease Psychosis
详细描述
This study will be conducted as a 16-week, multi-center, single-arm, open-label study. Pimavanserin will be administered at a dose of 34 mg to approximately 50 subjects with PDP
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects at least 40 years of age
- •Has a Mini-Mental State Examination (MMSE) score ≥19 at Screening
- •Has a diagnosis of idiopathic Parkinson's disease (PD)
- •Has psychotic symptoms that may impair function and are severe enough to warrant treatment with an antipsychotic agent
- •Psychotic symptoms developed after the onset of symptoms of PD
- •If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) OR must agree to use TWO clinically acceptable methods of contraception.
排除标准
- •Has atypical parkinsonism (Parkinson's plus, multiple system atrophy [MSA], progressive supranuclear palsy [PSP]), or secondary parkinsonism variants such as tardive or medication induced parkinsonism
- •Has undergone ablative procedures such as a pallidotomy, thalamotomy, or treatment with focused ultrasound, or has an implanted deep brain stimulator
- •Has current evidence of an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or psychiatric disorder, including cancer or malignancies that, in the judgment of the Investigator, would jeopardize the safe participation of the subject in the study or significantly interfere with the conduct or interpretation of the study
- •Has a history of myocardial infarction, unstable angina, acute coronary syndrome, or cerebrovascular accident within the last 6 months prior to Screening
- •Has any of the following:
- •greater than New York Heart Association (NYHA) Class 2 congestive heart failure
- •Grade 2 or greater angina pectoris (by Canadian Cardiovascular Society Angina Grading Scale)
- •sustained ventricular tachycardia
- •ventricular fibrillation
- •torsades de pointes
- •syncope due to an arrhythmia
- •an implantable cardiac defibrillator
- •Has a known personal or family history of long QT syndrome or family history of sudden cardiac death
- •Requires treatment with a medication or other substance that is prohibited by the protocol
- •Has a body mass index (BMI) <18.5 kg/m2 or >35 kg/m2 at Screening or Baseline or known unintentional clinically significant weight loss (i.e., ≥7%) over past 6 months
- •Is suicidal at Screening or Baseline
- •Has a history of a significant psychotic disorder prior to or concomitantly with the onset of PD including, but not limited to, schizophrenia or bipolar disorder
- •Had dementia prior to or concomitantly with the onset of motor symptoms of PD
- •Positive COVID-19 polymerase chain reaction (PCR) or antigen result in the last 2 weeks prior to screening
- •Is judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason
- •Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.
研究组 & 干预措施
Drug - Pimavanserin
Experimental
Pimavanserin 34 mg administered orally
干预措施: Pimavanserin (Drug)
结局指标
主要结局
Change From Baseline to Week 16 in Modified Functional Status Questionnaire (mFSQ) Total Score
时间窗: 16 weeks
The mFSQ is a self-administered questionnaire. It comprises 34 core items that produce 6 summary scale scores (i.e. basic activities of daily living (ADL); intermediate ADL; psychological function and mental health; work performance, social activity, and quality of interaction) and 6 single-item scores (work situation; days/month in bed due to illness/injury; days/month when illness/injury reduced activities normally performed for half a day; satisfaction with sexual relationship; satisfaction with health; frequency of social interaction). The mFSQ is calculated as the unweighted mean of predefined subscale scores. The maximum mFSQ total score is 100, with higher scores indicating better functional status. The minimum score is 0 and the maximum score is 100.
次要结局
- Change From Baseline to Week 16 on the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I and II(16 Weeks)
- Week 16 Clinical Global Impression - Improvement (CGI-I) Score for Hallucinations and Delusions(16 Weeks)
- Change From Baseline to Week 16 on the Schwab and England Activity of Daily Living (ADL) Scale, Caregiver and Patient Versions(16 Weeks)
- Change From Baseline to Week 16 on the Clinical Global Impression - Severity of Illness (CGI-S) Score for Hallucinations and Delusions(16 Weeks)
- Patient Global Impression of Improvement (PGI-I) Score for Hallucinations and Delusions at Week 16(16 Weeks)
研究者
研究点 (18)
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