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Recruiting NCT05140148

Promoting Recovery After STroke With Amantadine

Phase II Interventional Stroke, Ischemic Stroke Hemorrhagic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Amantadine, Placebo.
Who it may be relevant to
Registry conditions: Stroke, Ischemic, Stroke Hemorrhagic. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Amantadine
    Amantadine is a antiviral drug and dopamine promoter that is currently approved by the FDA for the treatment of influenza A and Parkinson's Disease
  • Drug Placebo
    placebo pills

Primary outcome measures

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Time frame: Day 90]
Secondary outcome measures (7)
  • Global rating on the Stroke Impact Scale (SIS) [Time frame: 90 days]
  • Total score on the National Institute of Health Stroke Scale (NIHSS) [Time frame: 90 days]
  • Digit Symbol Substitution Test (DSST) score [Time frame: 90 Days]
  • Montreal Cognitive Assessment test (MOCA) score [Time frame: 90 Days]
  • Patient Health Questionnaire (PHQ-9) score [Time frame: 90 days]
  • Upper limb strength [Time frame: 90 Days]
  • Modified Rankin Score (mRS) [Time frame: 90 days]

Eligibility criteria

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) -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • The Hospital of the University of Pennsylvania — Philadelphia

Identifiers

NCT: NCT05140148 · 849451

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗