Recruiting PHASE2 Stroke, Ischemic

New treatment option for Stroke, Ischemic

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 as a potential treatment for stroke, ischemic.

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 investigators aim to examine whether amantadine can help patients recover from stroke. This will be a blinded randomized clinical trial (RCT).
  • 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
Who can join
  • 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
What rules you out
  • 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 people who...
  • 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's taking place

  • Philadelphia, Pennsylvania, United States

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

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 - 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?

Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.