NCT05140148RecruitingPhase 2
Promoting Recovery After STroke With Amantadine
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 15 Sept 2021
- Start date
- 1 Feb 2022
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- University of Pennsylvania
- Diseases
- Stroke
- NCT number
- NCT05140148
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 1 Feb 2022 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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) -
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Hospital of the University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.