RECRUITING

Promoting Recovery After STroke With Amantadine

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Conditions

Stroke, IschemicStroke Hemorrhagic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Promoting Recovery After STroke With Amantadine

Quick Facts

Study Start:2022-02-01
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05140148

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18 to 85 years old, male and female
  2. 2. Modified Rankin Score (mRS)\<=2 prior to stroke
  3. 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. 4. 24 hours to 3 weeks after stroke onset or time last known well prior to detection of symptoms
  5. 5. National Institute of Health Stroke Scale (NIHSS)\>=3 and NIHSS\<=15
  6. 6. Creatinine Clearance of greater than or equal to 60 mL/min using the Cockroft- Gault equation.
  7. 7. Have passed a swallow evaluation prior to drug administration
  8. 8. The patient is an acute rehabilitation candidate or candidate for the Homeward Stroke Program
  9. 9. Able to participate in administered tests
  1. 1. Any degree of receptive aphasia
  2. 2. Moderate or severe expressive aphasia
  3. 3. Currently pregnant or plans to get pregnant
  4. 4. Currently breastfeeding
  5. 5. Any patient admitted with primary SubarachnoidH emorrhage (SAH )on either non-contrast head CT or MRI brain
  6. 6. Diagnosis of dementia or mild cognitive impairment prior to index stroke
  7. 7. Prior limb amputation
  8. 8. Currently prescribed or taking a primary anticholinergic medication
  9. 9. Currently enrolled in any other investigational pharmacologic or procedural clinical trial
  10. 10. Malignancy with active treatment
  11. 11. History of prior stroke with residual impairment
  12. 12. Current or prior neuroleptic use
  13. 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. 14. Prior history of seizures
  15. 15. Prior treatment with amantadine
  16. 16. Parkinson's disease
  17. 17. Amantadine allergy
  18. 18. Elevated liver function tests (aspartate aminotransferase and alanine aminotransferase above the upper limit of normal) -

Contacts and Locations

Study Contact

Aaron Rothstein, M.D
CONTACT
267-624-4442
aaron.rothstein@pennmedicine.upenn.edu
Nichole Gallatti, M.S.Ed.
CONTACT
nichole.gallatti@pennmedicine.upenn.edu

Study Locations (Sites)

The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-01
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2022-02-01
Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Stroke, Ischemic
  • Stroke Hemorrhagic