Using amantadine to help stroke recovery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of amantadine in promoting recovery in patients who have experienced ischemic or hemorrhagic strokes. Participants will be randomly assigned to receive either amantadine or a placebo for one month, with a total enrollment period of three months. Throughout the trial, patients will undergo assessments and complete questionnaires to evaluate their recovery progress. The study aims to provide insights into the potential benefits of amantadine for stroke rehabilitation.

Why it matters

Who can join: the full rules

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) -

Where it's running

• The Hospital of the University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Aaron Rothstein, M.D
• Email: aaron.rothstein@pennmedicine.upenn.edu
• Phone: 267-624-4442

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Emergency Stroke Unit for treating acute strokes

  This study is testing a new Emergency Stroke Unit that uses a mobile MRI to see if it can help treat stroke patients faster and improve their recovery.

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• Comparing reactive balance training with and without electrical stimulation for stroke recovery

  This study is testing whether adding electrical stimulation to balance training can help people who have had a stroke improve their balance better than training without it.

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• Using the Atalante exoskeleton to help stroke patients walk again

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• Understanding how vision loss affects driving in virtual reality

  This study tests how vision loss from a stroke affects driving skills in a virtual reality setting to help understand the challenges faced by people with visual field defects.

  Recruiting University of Rochester · Rochester, New York · NCT06047717

• Evaluating C7 Nerve Transfer for Stroke Recovery

  This study is testing if a surgery that connects a healthy part of the brain to the arm can help people who haven't improved their arm function after a stroke for 1-5 years.

  Recruiting Dartmouth-Hitchcock Medical Center · Lebanon, New Hampshire · NCT06001736

• Early rehabilitation using EEG neurofeedback for stroke recovery

  This study tests if using brainwave feedback along with regular rehab can help stroke patients recover better use of their arms.

  Recruiting Rennes University Hospital · Rennes · NCT05884762

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.