PRESTA: Caroline

Eligibility ChecklistDownload

Inclusion criteria:

  1. 18 to 85 years old, male and female
  2. 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. 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 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)

List of prohibited cholinergic medications:

  • atropine (Atropen)
  • belladonna alkaloids
  • benztropine mesylate (Cogentin)
  • clidinium
  • cyclopentolate (Cyclogyl)
  • darifenacin (Enablex)
  • dicylomine
  • fesoterodine (Toviaz)
  • flavoxate (Urispas)
  • glycopyrrolate
  • homatropine hydrobromide
  • hyoscyamine (Levsinex)
  • ipratropium (Atrovent)
  • orphenadrine
  • oxybutynin (Ditropan XL)
  • propantheline (Pro-banthine)
  • scopolamine
  • methscopolamine
  • solifenacin (VESIcare)
  • tiotropium (Spiriva)
  • tolterodine (Detrol)
  • trihexyphenidyl
  • trospium

Note: Women and members of minority groups will be included in accordance with the NIH Policy on Inclusion of Women and Minorities as Participants in Research Involving Human Subjects.