Using amantadine to help stroke recovery
Promoting Recovery After STroke With Amantadine
This study tests if the medication amantadine can help people recover better after having a stroke.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05140148 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 85 who have experienced an ischemic or hemorrhagic stroke and meet specific neurological assessment criteria.
Not a fit: Patients with significant expressive or receptive aphasia, or those with primary subarachnoid hemorrhage, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance recovery outcomes for stroke patients, potentially improving their quality of life.
How similar studies have performed: Previous studies have explored the use of amantadine for stroke recovery, showing promising results, but this specific approach is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Philadelphia, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.