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Recruiting

NCT Number: NCT05140148

Promoting Recovery After STroke With Amantadine

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.

Recruiting

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Nichole Gallatti

CONTACT

[email protected]

Scott Kasner, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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) -

Treatment and study plan

Amantadine

Drug

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

Placebo

Drug

placebo pills

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: Day 90

    Tolerability of the study drug will be assessed based on the proportion of patients who adherent with at least 80% of study medication.

Secondary outcomes

  1. Global rating on the Stroke Impact Scale (SIS)

    Time frame: 90 days

    Patient reported measure of stroke recovery; Stroke Impact Scale has 59 items in 8 domains (each domain score ranges from 0-100) And a 9th domain that is an overall scale from 0-100. Each item in the first 8 domains is on a likert scale from 1-5 where 5 is better and 1 is worse

  2. Total score on the National Institute of Health Stroke Scale (NIHSS)

    Time frame: 90 days

    Assessment for stroke deficits in patients; scores range from 0-42, with a higher score indicating more severe stroke symptoms

  3. Digit Symbol Substitution Test (DSST) score

    Time frame: 90 Days

    Cognitive test; scores range from 0 to 100, with higher scores indicating higher cognitive function

  4. Montreal Cognitive Assessment test (MOCA) score

    Time frame: 90 Days

    Cognitive test; scores range from 0 to 30, with higher scores indicating higher cognitive function

  5. Patient Health Questionnaire (PHQ-9) score

    Time frame: 90 days

    Patient reported survey of depression symptoms; scores range from 0 to 27, with higher scores indicating higher levels of depression

  6. Upper limb strength

    Time frame: 90 Days

    The upper limb strength for each subject with be measured using a hand dynamometer

  7. Modified Rankin Score (mRS)

    Time frame: 90 days

    Assessment of post-stroke recovery; scores range from 0 to 6, with higher scores indicating more severe impairments on daily functioning

Study contacts

Contact information is provided by the study sponsor or research team.

Aaron Rothstein, M.D

CONTACT

[email protected]

267-624-4442

Nichole Gallatti, M.S.Ed.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Acronym: PRESTA

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Dec 1, 2021
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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