Stroke Hemorrhagic, Stroke, Ischemic
Conditions
Brief summary
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.
Interventions
DRUGAmantadine
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
DRUGPlacebo
placebo pills
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. 18 to 85 years old, male and female 2. Modified Rankin Score (mRS)\<=2 prior to stroke 3. Ischemic or hemorrhagic stroke as diagnosed by vascular neurologist or as proven on magnetic resonance imaging (MRI) or non-contrast head computed tomography NCHCT) 4. 24 hours to 3 weeks after stroke onset or time last known well prior to detection of symptoms 5. National Institute of Health Stroke Scale (NIHSS)\>=3 and NIHSS\<=15 6. Creatinine Clearance of greater than or equal to 60 mL/min using the Cockroft- Gault equation. 7. Have passed a swallow evaluation prior to drug administration 8. The patient is an acute rehabilitation candidate or candidate for the Homeward Stroke Program 9. Able to participate in administered tests
Exclusion criteria
1. Any degree of receptive aphasia 2. Moderate or severe expressive aphasia 3. Currently pregnant or plans to get pregnant 4. Currently breastfeeding 5. Any patient admitted with primary SubarachnoidH emorrhage (SAH )on either non-contrast head CT or MRI brain 6. Diagnosis of dementia or mild cognitive impairment prior to index stroke 7. Prior limb amputation 8. Currently prescribed or taking a primary anticholinergic medication 9. Currently enrolled in any other investigational pharmacologic or procedural clinical trial 10. Malignancy with active treatment 11. History of prior stroke with residual impairment 12. Current or prior neuroleptic use 13. 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) 14. Prior history of seizures 15. Prior treatment with amantadine 16. Parkinson's disease 17. Amantadine allergy 18. Elevated liver function tests (aspartate aminotransferase and alanine aminotransferase above the upper limit of normal) -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global rating on the Stroke Impact Scale (SIS) | 90 days | 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 |
| Total score on the National Institute of Health Stroke Scale (NIHSS) | 90 days | Assessment for stroke deficits in patients; scores range from 0-42, with a higher score indicating more severe stroke symptoms |
| Digit Symbol Substitution Test (DSST) score | 90 Days | Cognitive test; scores range from 0 to 100, with higher scores indicating higher cognitive function |
| Montreal Cognitive Assessment test (MOCA) score | 90 Days | Cognitive test; scores range from 0 to 30, with higher scores indicating higher cognitive function |
| Patient Health Questionnaire (PHQ-9) score | 90 days | Patient reported survey of depression symptoms; scores range from 0 to 27, with higher scores indicating higher levels of depression |
| Upper limb strength | 90 Days | The upper limb strength for each subject with be measured using a hand dynamometer |
| Modified Rankin Score (mRS) | 90 days | Assessment of post-stroke recovery; scores range from 0 to 6, with higher scores indicating more severe impairments on daily functioning |
Countries
United States
Contacts
CONTACTAaron Rothstein, M.D
CONTACTNichole Gallatti, M.S.Ed.
Outcome results
None listed