A Study to Assess Effectiveness, Safety, and Health-related Outcomes of NUEDEXTA® (Dextromethorphan Hydrobromide and Quinidine Sulfate) for the Treatment of Pseudobulbar Affect (PBA) in Nursing Home Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 主要终点
- Scores on the Impact of Pseudobulbar Affect (PBA) on Participant Scale
研究概览
简要总结
6 month study of NUEDEXTA ® (Dextromethorphan Hydrobromide and Quinidine Sulfate) for the treatment of Pseudobulbar Affect (PBA) in Nursing Home Patients.
详细描述
Eligible patients for this study must have a diagnosis of a neurological disorder affecting the brain of at least 3 months duration prior to baseline and which is not rapidly progressing and must have a diagnosis of Pseudobulbar affect (PBA).
This is a multicenter, open label study consisting of 6 months of treatment.
Approximately 125 patients will be enrolled at approximately 25 centers in the United States.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a neurological disorder affecting the brain (e.g. Alzheimer's and other dementias, stroke, Trauma Brain Injury, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Huntington's disease, Parkinson's disease) of at least 3 months duration prior to baseline and which is not rapidly progressing
- •Diagnosis of Pseudobulbar Affect (PBA)
- •A Center for Neurologic Study-Lability Scale (CNS-LS) score of 13 or greater at Baseline
- •Minimum Data Set (MDS) information for patient available within 60 days prior to Baseline
- •Informant who is willing to comply with study procedures
排除标准
- •Patients who have received NUEDEXTA® in the past 1 year
- •Patients with the diagnosis of Severe Depressive Disorder that would interfere with the conduct of the study
- •Patients who have a history of schizophrenia spectrum and other psychotic disorders
- •Patients with co-existent clinically significant or unstable systemic diseased that could confound the interpretation of the safety results of the study (e.g.,malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
- •Patients with myasthenia gravis
研究组 & 干预措施
NUEDEXTA®
NUEDEXTA capsules (20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate) administered orally, once a day from Days 1 to 7 and twice a day from Days 8 to 180
干预措施: NUEDEXTA® (Drug)
结局指标
主要结局
Scores on the Impact of Pseudobulbar Affect (PBA) on Participant Scale
时间窗: 180 days
The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.
Number of Participants Using Concomitant Psychotropic Medication
时间窗: 180 days
The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.
Scores on the Impact of PBA on Informant Scale
时间窗: 180 days
The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.
Scores on the Center for Neurologic Study-Lability Scale (CNS-LS)
时间窗: 180 days
The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.
Scores on the Clinical Global Impression of Severity of Illness (CGIS) Scale
时间窗: 180 days
The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.
Scores on the Patient Global Impression of Change (PGIC) Scale
时间窗: 180 days
The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.
Scores on the Clinical Global Impression of Change (CGIC) Scale
时间窗: 180 days
The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.
Number of Participants With the Indicated Responses to the Neuropsychiatric Inventory-Nursing Home (NPI-NH) Questionnaire
时间窗: 180 days
The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.
Scores on the Minimum Data Set (MDS) Sections of Presumed Relevance to PBA, Including Sections on Speech, Cognition, Mood, Behavior, Health Condition, and Medication
时间窗: 180 days
The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.
次要结局
未报告次要终点