Tests amantadine to help adults recover after stroke
Tests amantadine against a placebo in adults recovering from ischemic or hemorrhagic stroke.
Plain-language title generated from the registry record
Registry title: Promoting Recovery After STroke With Amantadine
Key facts
- Where
- Philadelphia, United StatesSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT05140148, who can take part
Where in United States
- The Hospital of the University of PennsylvaniaPhiladelphia, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Pennsylvania
- Trial code
- NCT05140148
- Record updated
- 30 March 2026
- Original 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.Read full original descriptionShow less
Promoting Recovery After STroke With Amantadine
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.
Inclusion: 18 to 85 years old, male and female; Modified Rankin Score (mRS)<=2 prior to stroke; Ischemic or hemorrhagic stroke as diagnosed by vascular neurologist or as proven on magnetic resonance imaging (MRI) or non-contrast head computed tomography NCHCT); 24 hours to 3 weeks after stroke onset or time last known well prior to detection of symptoms; National Institute of Health Stroke Scale (NIHSS)>=3 and NIHSS<=15; Creatinine Clearance of greater than or equal to 60 mL/min using the Cockroft- Gault equation; Have passed a swallow evaluation prior to drug administration; The patient is an acute rehabilitation candidate or candidate for the Homeward Stroke Program; Able to participate in administered tests.
Exclusion: Diagnosis of dementia or mild cognitive impairment prior to index stroke; Prior limb amputation; Currently prescribed or taking a primary anticholinergic medication; History of prior stroke with residual impairment; Current or prior neuroleptic use; Prior history of seizures; Prior treatment with amantadine; Malignancy with active treatment; 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); Parkinson's disease; Amantadine allergy; Any degree of receptive aphasia; Moderate or severe expressive aphasia; Currently pregnant or plans to get pregnant; Currently breastfeeding; Any patient admitted with primary SubarachnoidH emorrhage (SAH )on either non-contrast head CT or MRI brain; Currently enrolled in any other investigational pharmacologic or procedural clinical trial; Elevated liver function tests (aspartate aminotransferase and alanine aminotransferase above the upper limit of normal) -.