A Double-Blind, Placebo-Controlled, Proof-of-Concept Clinical Study of the P38 Alpha Kinase Inhibitor Neflamapimod on Recovery After Moderate to Severe Acute Ischaemic Stroke
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 21
- 主要终点
- Change from baseline to Week 12 in the Timed Up and Go Test (TUG)
研究概览
简要总结
The purpose of this interventional study is to determine whether neflamapimod can improve residual physical disability and/or cognitive dysfunction after Moderate to Severe Acute Ischaemic 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)
盲法说明
Double-blind
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants must be aged 45 years or over at the time of signing the informed consent.
- •Confirmed acute ischaemic stroke in the anterior circulation (middle or anterior cerebral artery) with onset of symptoms between 2 and 7 days prior to screening and evaluation.
- •National Institutes of Health Stroke Scale (NIHSS) score between 5 and 20 (inclusive) and exhibiting unilateral motor deficit (i.e. motor NIHSS ≥ 2 on affected side of the body).
- •Fugl-Meyer Assessment of Motor Recovery after Ischaemic Stroke (FMMS) total motor components score of 80 or below.
- •No history of learning difficulties that may interfere with their ability to complete the cognitive tests.
排除标准
- •Evidence of progressive or unstable stroke or intra-cerebral haemorrhage in the opinion of the investigator
- •Participants needing carotid surgery within 3 months
- •Ongoing major and active psychiatric disorder and/or other concurrent medical condition that, in the opinion of the Investigator, might compromise safety and/or compliance with study requirements.
- •History of alcohol or drug abuse within the previous 2 years.
- •Poorly controlled clinically significant medical illness, such as hypertension (blood pressure >180 mmHg systolic or 100 mmHg diastolic); myocardial infarction within 6 months; uncompensated congestive heart failure or other significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would interfere with assessment of drug safety in the opinion of the Investigator.
- •Abnormal laboratory tests that, in the Investigator's assessment, mean that a participant is not appropriate for participation in this study, including, but not limited to:
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.0
- •× the upper limit of normal (ULN),
- •Total bilirubin >1.5 × ULN, and/or
- •International Normalised Ratio (INR) >1.5 NOTE: Participants with Gilbert's syndrome can be included with total bilirubin >1.5 x ULN as long as direct bilirubin is ≤ 1.5 x ULN)
研究组 & 干预措施
Cohort 1 placebo
Placebo will be administered with food for 12 weeks in subjects with Moderate to Severe Acute Ischaemic Stroke. Subjects will receive 3 capsules per day (TID) with food (i.e., with the morning, mid-day and evening meals).
干预措施: Placebo (Drug)
Cohort 2 placebo
Placebo will be administered with food for 12 weeks in subjects with Moderate to Severe Acute Ischaemic Stroke. Subjects will receive 2 capsules twice per day (BID) with food (i.e., with the morning and evening meals).
干预措施: Placebo (Drug)
Cohort 1 neflamapimod
Neflamapimod will be administered with food for 12 weeks in subjects with Moderate to Severe Acute Ischaemic Stroke. Subjects will receive 3 capsules per day (TID) with food (i.e., with the morning, mid-day and evening meals).
干预措施: Neflamapimod (Drug)
Cohort 2 neflamapimod
Neflamapimod will be administered with food for 12 weeks in subjects with Moderate to Severe Acute Ischaemic Stroke. Subjects will receive 2 capsules twice per day (BID) with food (i.e., with the morning and evening meals).
干预措施: Neflamapimod (Drug)
结局指标
主要结局
Change from baseline to Week 12 in the Timed Up and Go Test (TUG)
时间窗: From enrollment until the end of treatment at 12 weeks
The TUG test is recorded in seconds. The test has no minimum or maximum value, and an increase in the time required to complete the TUG is a worse outcome.
Change from baseline to Week 12 in National Institutes of Health Stroke Scale (NIHSS) motor score
时间窗: From enrollment until the end of treatment at 12 weeks
Scores for the NIHSS range from 0 to 42 where higher scores indicate greater impairment/worsening.
Change from baseline to Week 12 in Fugl-Meyer Assessment of Motor Recovery after Stroke (FMMS) motor score (upper and lower) and total score
时间窗: From enrollment until the end of treatment at 12 weeks
The FMMS test has a maximum upper motor score of 66, maximum lower motor score of 34, and a maximum total score of 212, where an increase indicates improved motor function while a decrease indicates worsening impairment.
次要结局
- Proportion of participants with Modified Rankin Scale (mRS) score of ≤ 2 at Week 12(From enrollment until the end of treatment at 12 weeks)
- Change from baseline to Week 12 in mean Barthel score(From enrollment until the end of treatment at 12 weeks)