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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | placebo pill, twice daily |
|
| Amantadine | Active Comparator | 100 mg amantadine twice daily, or if 65 years or older once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amantadine | Drug | 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 |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aaron Rothstein, M.D | Contact | 267-624-4442 | aaron.rothstein@pennmedicine.upenn.edu | |
| Nichole Gallatti, M.S.Ed. | Contact | nichole.gallatti@pennmedicine.upenn.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D000083302 | Hemorrhagic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000547 | Amantadine |
| ID | Term |
|---|---|
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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| Placebo | Drug | placebo pills |
|
| 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 |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009930 |
| Organic Chemicals |