Promoting Recovery After STroke with Amantadine
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
The investigators aim to examine whether amantadine can help patients recover from stroke. This will be a blinded randomized clinical trial (RCT). Patients will be randomized post-ischemic or hemorrhagic stroke either to the placebo arm or amantadine arm. Patients will be on study drug or placebo for 1 month but will be enrolled for 3 months total. At various time points patients will be examined and fill out questionnaires to determine level of stroke recovery.
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
- Triple (Participant, Care Provider, Investigator)
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
- •18 to 85 years old, male and female
- •Modified Rankin Score (mRS)<=2 prior to stroke
- •Ischemic or hemorrhagic stroke as diagnosed by vascular neurologist or as proven on magnetic resonance imaging (MRI) or non-contrast head computed tomography NCHCT)
- •24 hours to 3 weeks after stroke onset or time last known well prior to detection of symptoms
- •National Institute of Health Stroke Scale (NIHSS)>=3 and NIHSS<=15
- •Creatinine Clearance of greater than or equal to 60 mL/min using the Cockroft- Gault equation.
- •Have passed a swallow evaluation prior to drug administration
- •The patient is an acute rehabilitation candidate or candidate for the Homeward Stroke Program
- •Able to participate in administered tests
排除标准
- •Any degree of receptive aphasia
- •Moderate or severe expressive aphasia
- •Currently pregnant or plans to get pregnant
- •Currently breastfeeding
- •Any patient admitted with primary SubarachnoidH emorrhage (SAH )on either non-contrast head CT or MRI brain
- •Diagnosis of dementia or mild cognitive impairment prior to index stroke
- •Prior limb amputation
- •Currently prescribed or taking a primary anticholinergic medication
- •Currently enrolled in any other investigational pharmacologic or procedural clinical trial
- •Malignancy with active treatment
- •History of prior stroke with residual impairment
- •Current or prior neuroleptic use
- •History of suicidality or psychosis (The Columbia Suicide Severity Ratings Scale (C-SSRS) will be administered at the screening visit to assess depression and suicidal thoughts for subject eligibility. Any subjects who indicate severe depression or suicidal thoughts and/or attempts within the last year will not be eligible)
- •Prior history of seizures
- •Prior treatment with amantadine
- •Parkinson's disease
- •Amantadine allergy
- •Elevated liver function tests (aspartate aminotransferase and alanine aminotransferase above the upper limit of normal) -
研究组 & 干预措施
Placebo
placebo pill, twice daily
干预措施: Placebo (Drug)
Amantadine
100 mg amantadine twice daily, or if 65 years or older once daily
干预措施: Amantadine (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: Day 90
Tolerability of the study drug will be assessed based on the proportion of patients who adherent with at least 80% of study medication.
次要结局
- Modified Rankin Score (mRS)(90 days)
- Global rating on the Stroke Impact Scale (SIS)(90 days)
- Total score on the National Institute of Health Stroke Scale (NIHSS)(90 days)
- Digit Symbol Substitution Test (DSST) score(90 Days)
- Montreal Cognitive Assessment test (MOCA) score(90 Days)
- Patient Health Questionnaire (PHQ-9) score(90 days)
- Upper limb strength(90 Days)
研究者
Scott Kasner, MD
Professor of Neurology
University of Pennsylvania