NCT02530307终止2 期
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled 21-Day Treatment Study, Including an fMRI Sub-Study, to Evaluate the Effect of HT-3951 on Upper Extremity Motor Function Following Ischemic Stroke
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 61
- 主要终点
- Fugl-Meyer Assessment of Upper Extremity, Part A-D
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled parallel group outpatient study that will utilize standard stroke rehabilitation outcome measures, as well as fMRI techniques in a subset of subjects, to evaluate the effect of HT-3951 on motor recovery and behavior in medically stable subjects following 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range between 21 to 85 years, inclusive, at the Screening Visit
- •Subjects who have experienced an ischemic stroke documented by CT or MRI resulting in an upper extremity deficit that, in the opinion of the Investigator, warrants the need for rehabilitation therapy
- •Medically stable subjects who are able to be randomized to study medication beginning between ≥ 2 and ≤ 52 weeks post-stroke
- •Subjects who have initiated, are undergoing, have completed or agree to begin physical or occupational rehabilitation for at least 2 weeks prior to study Day
- •Mild to moderate unilateral upper extremity motor impairment characterized by FMA-EU score of > 18
- •Modified Rankin Scale score of 1 to 4
排除标准
- •History of stroke within 6 months prior to the subject's current episode of ischemic stroke (History of transient ischemic attacks or ischemic stroke (nonhemorrhagic) more than 6 months prior to the current ischemic stroke are acceptable.)
- •Subjects with unresolved upper or lower motor deficits (e.g., range of motion or strength deficits) from any prior stroke
- •Significant hemorrhagic stroke
- •Any history of seizure disorder or a spontaneous seizure that had occurred at any time after the stroke
- •Apraxia that, in the Investigator's opinion, would likely reduce the ability of the subject to participate in the study or confound study outcome measures
- •Moderate to severe aphasia and/or severe language deficits
- •Severe sensory loss in affected hand
- •Moderate to severe hemispatial neglect or anosognosia involving the affected arm
- •Absent proprioception at the elbow or shoulder joints
- •Excessive spasticity in the affected elbow, defined as a score of greater than or equal to 3 on the Modified Ashworth Spasticity scale (MAS)
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo capsules administered once daily
干预措施: Placebo (Drug)
HT-3951 (15mg)
Experimental
HT-3951 capsules administered once daily
干预措施: HT-3951 (Drug)
结局指标
主要结局
Fugl-Meyer Assessment of Upper Extremity, Part A-D
时间窗: 21-days
Stroke Impact Scale (hand domain)
时间窗: 21-days
Hand Grip Strength Dynamometer Test
时间窗: 21-days
Arm Motor Ability Test-9
时间窗: 21-days
Index Finger-Tapping Frequency Test
时间窗: 21-days
Nine-Hole Peg Test
时间窗: 21-days
Somatosensory evoked potential (if available)
时间窗: 21-days
次要结局
- Two-Minute Walk Test(21-days)
- Behavioral, neural activity and motor network connectivity levels, using functional MRI(21-days)
研究者
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