NCT02258880撤回2 期
A Phase 2, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SUN13837 Administered 28 Doses (27/28 Days) to Adult Subjects With an Acute Ischemic Stroke
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Mean change from baseline in the Physical Performance Assessment in Stroke (PPAS)
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of SUN13837 and to determine whether SUN13837 improves the physical performance, relative to placebo, following an acute stroke in adult subjects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Subjects who meet any of the following criteria will be excluded from the study:
- •Prior exposure to SUN13837
- •History of severe allergic reaction, whether explained or not, requiring a visit to the ER and/or medical intervention with epinephrine
- •Development of hemodynamic instability following the acute stroke
- •History of dementia, advanced Parkinson's disease, other significant movement disorders, or other clinically significant diseases which would jeopardize the safety of the subject or impact the validity of the study results
- •Presence of significant global or receptive aphasia
- •Presence of clinically significant abnormal laboratory values at the time of presentation in the ER
- •History of malabsorption or any gastrointestinal abnormality that could impair oral absorption
- •Finding of Grade 3 or 4 proliferative retinopathy on routine fundoscopic examination or history of proliferative retinopathy (Grade 3 or 4) in subjects with diabetes mellitus
- •Unable, as determined by the investigator, or unwilling to discontinue use of potent cytochrome (CYP) P450 3A4/5 inhibitors, potent CYP2D6 inhibitors, CYP3A inducers, or potent P glycoprotein (P gp) inhibitors
- •Current participation in another clinical study involving administration of an investigational product or history of such participation within 30 days of acute stroke onset
研究组 & 干预措施
SUN13837
Experimental
Drug: SUN13837 daily for 28 days.
干预措施: SUN13837 (Drug)
Placebo
Placebo Comparator
Placebo: Matching Placebo daily for 28 days
干预措施: placebo (Drug)
结局指标
主要结局
Mean change from baseline in the Physical Performance Assessment in Stroke (PPAS)
时间窗: 84 days
次要结局
- Mean change from baseline in Gait Speed(84 days)
- The proportion of responders as measured by the PPAS(84 days)
- Mean change from baseline in PPAS Patient Reported Outcome Subscale(84 days)
- Mean change from baseline in Short Form-36 Physical Functioning Scale (SF-36 PF)(84 days)
- Proportion of responders as measured by the Modified Rankin Scale (mRS)(84 days)
- Safety/Tolerability - Number of Participants with Adverse Events(84 days)
研究者
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