A Study to Assess the Safety, Tolerability and Effectiveness of Nuedexta (Dextromethorphan 20 mg/Quinidine 10 mg) in the Treatment of Pseudobulbar Affect (PBA)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 367
- 主要终点
- Mean Change From Baseline in Center for Neurologic Study-Lability Scale (CNS-LS) Score at Day 90
研究概览
简要总结
The objectives of the study are to evaluate the safety, tolerability, and effectiveness of NUEDEXTA capsules containing 20 mg DM (Dextromethorphan)/10 mg Q (Quinidine) for treatment of Pseudobulbar Affect (PBA) in patients with prevalent conditions such as dementia, stroke, and traumatic brain injury (TBI)over a 12 week period.
详细描述
This will be an Open-label, Multicenter, study in patients with PBA and dementia, stroke or TBI. Patients with a clinical diagnosis of PBA and who meet all other inclusion and exclusion criteria will be eligible to participate and receive NUEDEXTA for 12 weeks.
Males and females patients with a minimum age of 18 years, a clinical diagnosis of Pseudobulbar Affect and a documented diagnosis of neurologic disease or brain injury, will be enrolled in this study.
The primary effectiveness endpoint is the mean change in the Center for Neurologic Study-Lability scale (CNS-LS). Secondary objectives include measures to evaluate treatment outcomes.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Center for Neurologic Study-Lability Scale (CNS-LS)score of 13 or greater
- •Clinical diagnosis of Pseudobulbar Affect (PBA)
- •Documentation of Neurologic disease or brain injury
排除标准
- •Unstable neurologic disease
- •Severe dementia
- •Stroke within 3 months
- •Penetrating TBI
- •Contraindications to Nuedexta
- •Severe Depressive Disorder
研究组 & 干预措施
Nuedexta (DM 20 mg/Q 10 mg)
Single Arm, Open Label Dosing with Nuedexta (DM 20 mg/Q 10 mg)
干预措施: Nuedexta (DM 20 mg/Q 10 mg) (Drug)
结局指标
主要结局
Mean Change From Baseline in Center for Neurologic Study-Lability Scale (CNS-LS) Score at Day 90
时间窗: Day 90 (Final visit)
The CNS-LS was a seven-item, self-administered questionnaire, completed by the participant or participant's caregiver that provided a quantitative measure of the perceived frequency and severity of Pseudobulbar Affect (PBA) episodes. It consisted of two subscales measuring labile laughter (four items) and labile crying (three items). Each item was rated on a scale from 1 (applies never) to 5 (applies most of the time). The total score was calculated as the sum of the item values that resulted in a score ranging from 7 (no symptoms) to 35 (maximum symptom severity and frequency). A single continuous variable was created for the reported time point. The change in CNS-LS was calculated as the score from the Day 90 assessment minus the Baseline CNS-LS measure. A negative change represented a decrease in CNS-LS score over time following the baseline assessment indicating a perceived decrease in frequency and severity of PBA episodes.
次要结局
- Mean Pseudobulbar Affect (PBA) Episode Count Per Week by Visit(Baseline (Day 1), Day 30 (Visit 1), and Day 90 (Final visit))
- Percentage of Participants With ≥ 75% Reduction in PBA Episode Count Per Week(Day 30 (Visit 1) and Day 90 (Final visit))
- Percentage of Participants With PBA Remission(Day 30 (Visit 1) and Day 90 (Final visit))
- Percentage of Participants With ≥ 50% Reduction in PBA Episode Count Per Week(Day 30 (Visit 1) and Day 90 (Final visit))
- Mean Change From Baseline in Quality of Life Visual Analog Scale (QOL-VAS) Score at Day 90(Day 90 (Final visit))
- Mean Change From Baseline in Center for Neurologic Study-Lability Scale (CNS-LS) Score at Day 30(Day 30)
- Percentage Change From Baseline in PBA Episode Count Per Week(Day 30 (Visit 1) and Day 90 (Final visit))
- Percentage of Participants With Clinical Global Impression-Change (CGI-C) Score at Day 90(Day 90 (Final visit))
- Percentage of Participants With Patient Global Impression-Change (PGI-C) Score at Day 90(Day 90 (Final visit))
- Percentage of Participants With Treatment Satisfaction Survey(Day 90 (Final visit))
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From signing of informed consent up to 30 days after receiving the last dose of study drug or up to approximately 120 days)