Promoting Recovery After STroke With Amantadine

Study Overview
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Brief Summary
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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.

Official Title
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Promoting Recovery After STroke With Amantadine

Conditions
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Stroke, Ischemic, Stroke Hemorrhagic

Intervention / Treatment
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* Drug: Amantadine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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) -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>placebo pill, twice daily | Drug: Placebo<br>* placebo pills<br>|
| Active Comparator: Amantadine<br>100 mg amantadine twice daily, or if 65 years or older once daily | Drug: Amantadine<br>* Amantadine is a antiviral drug and dopamine promoter that is currently approved by the FDA for the treatment of influenza A and Parkinson's Disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Tolerability of the study drug will be assessed based on the proportion of patients who adherent with at least 80% of study medication. | Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global rating on the Stroke Impact Scale (SIS) | Patient reported measure of stroke recovery; Stroke Impact Scale has 59 items in 8 domains (each domain score ranges from 0-100) And a 9th domain that is an overall scale from 0-100. Each item in the first 8 domains is on a likert scale from 1-5 where 5 is better and 1 is worse | 90 days | 
| Total score on the National Institute of Health Stroke Scale (NIHSS) | Assessment for stroke deficits in patients; scores range from 0-42, with a higher score indicating more severe stroke symptoms | 90 days | 
| Digit Symbol Substitution Test (DSST) score | Cognitive test; scores range from 0 to 100, with higher scores indicating higher cognitive function | 90 Days | 
| Montreal Cognitive Assessment test (MOCA) score | Cognitive test; scores range from 0 to 30, with higher scores indicating higher cognitive function | 90 Days | 
| Patient Health Questionnaire (PHQ-9) score | Patient reported survey of depression symptoms; scores range from 0 to 27, with higher scores indicating higher levels of depression | 90 days | 
| Upper limb strength | The upper limb strength for each subject with be measured using a hand dynamometer | 90 Days | 
| Modified Rankin Score (mRS) | Assessment of post-stroke recovery; scores range from 0 to 6, with higher scores indicating more severe impairments on daily functioning | 90 days |