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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
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
placebo pills
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGIncidence 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.
Time frame: Day 90
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
Time frame: 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
Time frame: 90 days
Digit Symbol Substitution Test (DSST) score
Cognitive test; scores range from 0 to 100, with higher scores indicating higher cognitive function
Time frame: 90 Days
Montreal Cognitive Assessment test (MOCA) score
Cognitive test; scores range from 0 to 30, with higher scores indicating higher cognitive function
Time frame: 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
Time frame: 90 days
Upper limb strength
The upper limb strength for each subject with be measured using a hand dynamometer
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Time frame: 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
Time frame: 90 days