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Antiviral Agent
Amantadine for Stroke Recovery (PRESTA Trial)
Phase 2
Recruiting
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Creatinine Clearance of greater than or equal to 60 mL/min using the Cockroft- Gault equation
18 to 85 years old, male and female
Must not have
Parkinson's disease
Currently prescribed or taking a primary anticholinergic medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 90
Summary
This trial will test whether amantadine can help people recover from a stroke. Patients will be randomly assigned to either take amantadine or a placebo, and will be monitored for recovery over the course of 3 months.
Who is the study for?
Adults aged 18-85 who've had a recent stroke (ischemic or hemorrhagic) and are in stable condition with mild to moderate impairment can join. They must have good kidney function, be able to swallow, and participate in tests. Excluded are those with severe communication difficulties, cognitive impairments before the stroke, certain medical conditions like active cancer or Parkinson's disease, prior amantadine use, or current participation in other drug trials.
What is being tested?
The trial is testing if amantadine helps stroke recovery compared to a placebo. Participants will randomly receive either the drug or placebo for one month and will be monitored for three months total through exams and questionnaires assessing their recovery progress.
What are the potential side effects?
While not specified here, common side effects of amantadine may include dizziness, upset stomach, difficulty concentrating, insomnia; however individual experiences may vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidneys are functioning well, with a creatinine clearance rate of 60 mL/min or more.
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I am between 18 and 85 years old.
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I was mostly independent before my stroke.
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I have had a stroke confirmed by a specialist or through imaging tests.
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I had a stroke between 24 hours and 3 weeks ago.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have Parkinson's disease.
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I am currently taking medication for muscle spasms or bladder issues.
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I have had seizures in the past.
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I have had a limb amputated.
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I have difficulty understanding spoken or written language.
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I have significant difficulty speaking or finding words.
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I have previously been treated with amantadine.
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I was diagnosed with dementia or mild cognitive impairment before my stroke.
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I have had a stroke that left me with lasting effects.
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I am currently receiving treatment for cancer.
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I have used or am using medication for mental health issues.
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I was admitted for a bleeding in the brain detected by CT or MRI.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 90
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 90
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Secondary study objectives
Digit Symbol Substitution Test (DSST) score
Global rating on the Stroke Impact Scale (SIS)
Modified Rankin Score (mRS)
+4 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: AmantadineActive Control1 Intervention
100 mg amantadine twice daily, or if 65 years or older once daily
Group II: PlaceboPlacebo Group1 Intervention
placebo pill, twice daily
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,079 Previous Clinical Trials
42,721,561 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have Parkinson's disease.I am currently taking medication for muscle spasms or bladder issues.I have had seizures in the past.I have had a limb amputated.You have had severe depression, suicidal thoughts, or attempts in the last year.My kidneys are functioning well, with a creatinine clearance rate of 60 mL/min or more.Your stroke severity score is between 3 and 15 on the NIH Stroke Scale.I am eligible for acute rehabilitation or the Homeward Stroke Program.I was diagnosed with dementia or mild cognitive impairment before my stroke.I was admitted for a bleeding in the brain detected by CT or MRI.I have difficulty understanding spoken or written language.I have significant difficulty speaking or finding words.I have previously been treated with amantadine.I am between 18 and 85 years old.I was mostly independent before my stroke.Your liver function tests show high levels of certain enzymes.You are allergic to amantadine.I have had a stroke that left me with lasting effects.I am currently receiving treatment for cancer.I have used or am using medication for mental health issues.I have successfully completed a swallow test.I have had a stroke confirmed by a specialist or through imaging tests.I had a stroke between 24 hours and 3 weeks ago.
Research Study Groups:
This trial has the following groups:- Group 1: Amantadine
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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