Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 85
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
University of Pennsylvania · Other
Who this trial is looking for
This trial is looking for people who have recently had a stroke. Participants will receive either the medication amantadine or a placebo for one month, while being monitored for their recovery over three months.
Are You a Good Fit for This Trial?
Must not be takingAnticholinergic medication
Rules you outPrimary subarachnoid hemorrhageMalignancy with active treatment
You may be able to join if
I am between 18 and 85 years old.
I had an ischemic or hemorrhagic stroke confirmed by medical testing.
I am between 24 hours and 3 weeks after my stroke.
I have a modified Rankin Score of 2 or less before my stroke.
I have a National Institute of Health Stroke Scale score between 3 and 15.
I have passed a swallow evaluation.
I am a candidate for rehabilitation services.
I can participate in tests.
You may not be able to join if
I have any degree of receptive aphasia.
I am currently pregnant or breastfeeding.
I have a history of seizures.
I have been diagnosed with dementia or mild cognitive impairment.
I have had a prior stroke with lasting effects.
I have a history of severe depression or suicidal thoughts in the past year.
I have Parkinson's disease.
I have an allergy to amantadine.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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Eligibility Criteria
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 week…
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) -
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