NCT05140148 · University of Pennsylvania
Promoting Recovery After STroke With Amantadine
(PRESTA)
What this study is about
The investigators aim to examine whether amantadine can help patients recover from stroke. This will be a blinded randomly assigned clinical trial (RCT). Patients will be randomly assigned post-ischemic or hemorrhagic stroke either to the placebo treatment group$1 or amantadine treatment group$1. Patients will be on study drug or placebo for 1 month but will be enrolled for 3 months total.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
- Diagnosis of dementia or mild cognitive impairment prior to index stroke
- Prior limb amputation
- Currently prescribed or taking a primary anticholinergic medication
- Currently enrolled in any other investigational pharmacologic or procedural clinical trial
- Malignancy with active treatment
- History of prior stroke with residual impairment
- Current or prior neuroleptic use
- 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)
- Prior history of seizures
- Prior treatment with amantadine
- Parkinson's disease
- Amantadine allergy
- Elevated liver function tests (aspartate aminotransferase and alanine aminotransferase above the upper limit of normal) -
Where
- Philadelphia, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 30, 2026 · Source of record for eligibility and locations