PRESTA: Promoting Recovery After STroke With Amantadine
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Placebo Comparator: Placebo placebo pill, twice daily |
Drug: Placebo
placebo pills
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Active Comparator: Amantadine 100 mg amantadine twice daily, or if 65 years or older once daily |
Drug: Amantadine
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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 to 85 years old, male and female
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Modified Rankin Score (mRS)<=2 prior to stroke
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Ischemic or hemorrhagic stroke as diagnosed by vascular neurologist or as proven on magnetic resonance imaging (MRI) or non-contrast head computed tomography NCHCT)
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24 hours to 3 weeks after stroke onset or time last known well prior to detection of symptoms
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National Institute of Health Stroke Scale (NIHSS)>=3 and NIHSS<=15
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Creatinine Clearance of greater than or equal to 60 mL/min using the Cockroft- Gault equation.
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Have passed a swallow evaluation prior to drug administration
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The patient is an acute rehabilitation candidate or candidate for the Homeward Stroke Program
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Able to participate in administered tests
Exclusion Criteria:
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Any degree of receptive aphasia
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Moderate or severe expressive aphasia
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Currently pregnant or plans to get pregnant
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Currently breastfeeding
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Any patient admitted with primary SubarachnoidH emorrhage (SAH )on either non-contrast head CT or MRI brain
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Diagnosis of dementia or mild cognitive impairment prior to index stroke
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Prior limb amputation
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Currently prescribed or taking a primary anticholinergic medication
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Currently enrolled in any other investigational pharmacologic or procedural clinical trial
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Malignancy with active treatment
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History of prior stroke with residual impairment
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Current or prior neuroleptic use
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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)
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Prior history of seizures
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Prior treatment with amantadine
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Parkinson's disease
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Amantadine allergy
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Elevated liver function tests (aspartate aminotransferase and alanine aminotransferase above the upper limit of normal) -
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | The Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- University of Pennsylvania
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 849451