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Phase 2Recruiting

Promoting Recovery After STroke With Amantadine

Sponsored by University of Pennsylvania

About this study

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.

Where this study is enrolling

  • The Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania

    I'm interested
Who can participate

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) -

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.