NCT02534038终止2 期
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Efficacy of AVP-786 for the Treatment of Disinhibition in Patients With Neurodegenerative Disorders
Avanir Pharmaceuticals2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2015年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Change From Baseline in the Disinhibition Domain of the Neuropsychiatric Inventory (NPI)
研究概览
简要总结
Treatment of disinhibition syndrome in participants with Neurodegenerative Disorder.
详细描述
Eligible participants for this study must have a diagnosis of Neurodegenerative Disorder and must exhibit disinhibition syndrome of sufficient severity to warrant treatment.
This is a multicenter, randomized, double-blind, placebo-controlled, cross-over study consisting of two 6-week treatment periods.
Approximately 12 participants will be enrolled at approximately 2 centers in the United States.
Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of a Neurodegenerative Disorder including frontotemporal dementia, Alzheimer's disease (AD), progressive supranuclear palsy (PSP), corticobasal degeneration (CBD), dementia with Lewy bodies (DBL), vascular cognitive disorders, or Huntington's disease, at least 3 months prior to Baseline
- •The participant has behavior from 2 of the 3 categories of disinhibited behavior from the definition of the behavioral variant of frontotemporal dementia
- •The behavioral changes are not due to a pre-existing major psychiatric disorder (e.g., schizophrenia, bipolar disease, etc.) and are not due to the direct effect of systemic illness, drug action, or substance use
- •Disinhibition scale score of ≥4 on the 3 core disinhibition items of the Frontal Behavioral Inventory (FBI) at Screening and Baseline
排除标准
- •Participants with symptoms of disinhibition that is not secondary to Neurodegenerative Disorders
- •Participants with myasthenia gravis
- •Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy [except skin basal-cell carcinoma or untreated prostate cancer], poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
研究组 & 干预措施
AVP-786
Active Comparator
Participants randomized to AVP-786 will take one dose of AVP-786 once a day and one dose of placebo once a day for the first 7 days; from day 8, participants will receive AVP-786 twice a day for 5 weeks.
干预措施: AVP-786 (Drug)
Placebo
Placebo Comparator
Placebo drug to be taken twice a day for 6 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Disinhibition Domain of the Neuropsychiatric Inventory (NPI)
时间窗: Baseline; Week 6, Week 8, and Week 14
次要结局
- Change From Baseline for the Total NPI Score(Baseline; Week 6, Week 8, and Week 14)
- Change From Baseline for the NPI Total Caregiver Distress(Baseline; Week 6, Week 8, and Week 14)
- Change From Baseline for the NPI Disinhibition Domain Caregiver Distress(Baseline; Week 1, Week 3, Week 6, Week 8, Week 9, Week 11, and Week 14)
- Change From the First Assessment for the Patient Global Impression of Change (PGIC) Scale(Week 3, Week 6, Week 11, and Week 14)
- Change From Baseline for the Quality of Relationships (QoR) Scale(Baseline; Week 6, Week 8, and Week 14)
- Change From Baseline for the Quality of Life (QoL) Scale(Baseline; Week 6, Week 8, and Week 14)
- Change From Baseline for the Frontal Behavioral Inventory (FBI) Total Score(Baseline; Week 1, Week 3, Week 6, Week 8, Week 9, Week 11, and Week 14)
- Change From Baseline for the FBI Disinhibition Domain Score(Baseline; Week 1, Week 3, Week 6, Week 9, Week 11, and Week 14)
- Change From the First Assessment for the Modified Clinical Global Impression of Change (mCGIC) Scale(Week 3, Week 6, Week 11, and Week 14)
- Change From Baseline for the Interpersonal Reactivity Index (IRI)(Baseline; Week 6, Week 8, and Week 14)
- Change From Baseline for the Center for Neurologic Study-Lability Scale (CNS-LS)(Baseline; Week 6, Week 8, and Week 14)
- Change From Baseline for the Mini-Mental State Examination (MMSE)(Baseline; Week 6, Week 8, and Week 14)
- Change From Baseline for the Cornell Scale for Depression in Dementia (CSDD)(Baseline; Week 6, Week 8, and Week 14)
- Change From Baseline for the Stroop Color and Word Task(Baseline; Week 6, Week 8, and Week 14)
研究者
研究点 (2)
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