A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Safety, Efficacy and Pharmacodynamic Study of Basmisanil (RO5186582) in Adults With Severe Motor Impairment Following an Ischemic Stroke
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 13
- 主要终点
- Change From Baseline in FMMS Score at Day 90
研究概览
简要总结
This Phase IIa, randomized, double-blind, placebo-controlled, parallel group study will evaluate the safety, efficacy and pharmacodynamics of basmisanil in adult participants with severe motor impairment following an ischemic stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiologic assessment confirming an acute middle cerebral artery ischemic stroke
- •Index stroke occurred within the past 3-4 days
- •Inpatient males and females
- •Severe hemiparesis or hemiplegia defined by FMMS score less than or equal to (</=) 35
- •Sufficient speech, vision and hearing to participate in study evaluations
排除标准
- •NIHSS greater than (>) 20
- •Severe aphasia that prevents a participant from following directions in rehabilitation
- •Significant deficit from prior strokes or pre-existing motor deficit
- •History of epilepsy, neurosurgery, severe head trauma or central nervous system infections that have residual symptomatology or have required treatment in the last 12 months
- •Known or suspected clinical seizure post-index stroke
- •History of pre-existing dementia or use of medications for dementia
- •History of clinically significant pre-existing psychiatric conditions within 12 months prior to stroke
- •Due to undergo carotid surgery within the next 4 months
- •Enrollment/participation in any interventional study (clinical trial) involving an investigational drug (unapproved) or non-drug treatment within the prior 3 months or 6 times the half-life (whichever is longer)
- •Clinically relevant medical conditions that would likely interfere with the study conduct and scheduled assessments
- •Contraindication to magnetic resonance imaging (MRI) or conditions which render interpretation of MRI difficult
研究组 & 干预措施
Basmisanil
Basmisanil at a dose of 240 milligrams (mg) orally twice daily for 90 days.
干预措施: Basmisanil (Drug)
Placebo
Placebo matched to basmisanil orally twice daily for 90 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in FMMS Score at Day 90
时间窗: Baseline (Day 1), Day 90
Number of Participants with Adverse Events
时间窗: Baseline (Day 1) up to 28 days after last dose of study drug (latest at Day 118)
Change From Baseline in Montreal Cognitive Assessment (MoCA) Score at Day 30
时间窗: Baseline (Day 1), Day 30
Change From Baseline in National Institute of Health Stroke Scale (NIHSS) Score At Day 3
时间窗: Baseline (Day 1), Day 3
Change From Baseline in NIHSS Score At Day 10
时间窗: Baseline (Day 1), Day 10
Change From Baseline in MoCA Score at Day 90
时间窗: Baseline (Day 1), Day 90
Change From Baseline in NIHSS Score At Day 30
时间窗: Baseline (Day 1), Day 30
Change From Baseline in NIHSS Score At Day 90
时间窗: Baseline (Day 1), Day 90
Change From Baseline in NIHSS Score At 28 Days After Last Dose
时间窗: Baseline (Day 1) and at 28 days after last dose of study drug (latest on Day 118)
Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Score At Day 3
时间窗: Baseline (Day 1), Day 3
Change From Baseline in C-SSRS Score At Day 30
时间窗: Baseline (Day 1), Day 30
Change From Baseline in C-SSRS Score At Day 60
时间窗: Baseline (Day 1), Day 60
Change From Baseline in C-SSRS Score At Day 90
时间窗: Baseline (Day 1), Day 90
Change From Baseline in C-SSRS Score At 28 Days After Last Dose
时间窗: Baseline (Day 1), at 28 days after last dose of study drug (latest on Day 118)
次要结局
- Change From Baseline in Modified Rankin Scale (mRS) Score At Day 90(Baseline (Day 1), Day 90)
- mRS Score At Day 90(Day 90)
- Change From Baseline in Fugl-Meyer Assessment (FMA) Total Score at Day 90(Baseline (Day 1), Day 90)
- Change From Baseline in FMA Subscale Score at Day 90(Baseline (Day 1), Day 90)
- Apparent Oral Clearance (CL/F) of Basmisanil(Predose (Hour 0) (prior to morning dose) on Days 3, 10, 30, 90; 4 and 8 hours post-morning dose on Day 1; and 4 hours post-morning dose on Day 3)
- Maximum Observed Plasma Concentration (Cmax) of Basmisanil(Predose (Hour 0) (prior to morning dose) on Days 3, 10, 30, 90; 4 and 8 hours post-morning dose on Day 1; and 4 hours post-morning dose on Day 3)
- Apparent Volume of Distribution at Steady States (Vss) of Basmisanil(Predose (Hour 0) (prior to morning dose) on Days 3, 10, 30, 90; 4 and 8 hours post-morning dose on Day 1; and 4 hours post-morning dose on Day 3)
- Area Under the Curve [AUC] of Basmisanil(Predose (Hour 0) (prior to morning dose) on Days 3, 10, 30, 90; 4 and 8 hours post-morning dose on Day 1; and 4 hours post-morning dose on Day 3)