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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
Have passed a swallow evaluation prior to drug administration
Creatinine Clearance of greater than or equal to 60 mL/min using the Cockroft- Gault equation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 90
Awards & highlights

PRESTA Trial 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.Check my eligibility
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.See study design
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.

PRESTA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have successfully completed a swallow test.
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My kidneys are functioning well, with a creatinine clearance rate of 60 mL/min or more.
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I am eligible for acute rehabilitation or the Homeward Stroke Program.
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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.

PRESTA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 90
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 90 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Secondary outcome measures
Digit Symbol Substitution Test (DSST) score
Global rating on the Stroke Impact Scale (SIS)
Modified Rankin Score (mRS)
+4 more

PRESTA Trial 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
1,994 Previous Clinical Trials
42,879,183 Total Patients Enrolled

Media Library

Amantadine (Antiviral Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05140148 — Phase 2
Hemorrhagic Stroke Research Study Groups: Amantadine, Placebo
Hemorrhagic Stroke Clinical Trial 2023: Amantadine Highlights & Side Effects. Trial Name: NCT05140148 — Phase 2
Amantadine (Antiviral Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05140148 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age cap for this research project 75 years old or younger?

"This clinical trial is open to applicants aged 18-85, with 40 studies specifically for those under the age of majority and 1055 others for individuals over 65."

Answered by AI

Is it feasible for me to join the ongoing clinical trial?

"This medical trial seeks to recruit approximately 60 individuals who have experienced a hemorrhagic stroke and are aged between 18 and 85 years."

Answered by AI

How many participants are enrolled in this experiment?

"Affirmative. Clinicaltrials.gov displays that this clinical trial, which was initially uploaded on February 1st 2022, is currently accepting applications. 60 participants are required to be sourced from a single medical centre."

Answered by AI

What measures are being taken to ensure the security of Amantadine for human consumption?

"Due to the lack of evidence for Amantadine's efficacy, our experts at Power assigned it a score of 2 on their safety scale."

Answered by AI

Are there opportunities for volunteers to partake in this research experiment?

"Affirmative. Clinicaltrials.gov records show that this research is currently sourcing applicants, with the trial having originally been posted on February 1st 2022 and last updated on December 2nd 2022. 60 volunteers are expected to be recruited from a single medical centre."

Answered by AI

What medical conditions is Amantadine typically employed to treat?

"Amantadine can be employed to ameliorate abnormal involuntary movement, parkinsonism post encephalitic, and restless legs syndrome. Additionally, it may be prescribed for prophylactic measures against contracting influenza A virus."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
~27 spots leftby Dec 2025