Stroke, Ischemic study: Amantadine
Official title Promoting Recovery After STroke With Amantadine
ClinicalTrials.gov ID: NCT05140148
What this study is testing
What is Amantadine?
Amantadine is an investigational medicine being studied for stroke recovery.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see whether amantadine can improve recovery in people who have had an ischemic or hemorrhagic stroke.
- Who it's for
- Adults who have recently had a stroke, either ischemic or hemorrhagic.
- What's involved
- Participants will receive either amantadine or a placebo for one month, and will have visits and questionnaires to track recovery.
- Time commitment
- The study lasts three months, with visits and assessments during that time.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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...
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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.
- 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) -
The study team makes the final eligibility decision.
Where it is enrolling
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.