Promoting Recovery After STroke with Amantadine

Last updated: February 25, 2025
Sponsor: University of Pennsylvania
Overall Status: Active - Recruiting

Phase

2

Condition

Stroke

Thrombosis

Blood Clots

Treatment

Placebo

Amantadine

Clinical Study ID

NCT05140148
849451
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 onmagnetic 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 ofsymptoms

  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- Gaultequation.

  7. Have passed a swallow evaluation prior to drug administration

  8. The patient is an acute rehabilitation candidate or candidate for the HomewardStroke Program

  9. Able to participate in administered tests

Exclusion

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 eithernon-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 clinicaltrial

  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 andsuicidal thoughts for subject eligibility. Any subjects who indicate severedepression or suicidal thoughts and/or attempts within the last year will not beeligible)

  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 alanineaminotransferase above the upper limit of normal) -

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
February 01, 2022
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • The Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

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