Stroke, IschemicPhase 2PRESTANCT05140148
Promoting Recovery After STroke With Amantadine
A Phase 2 study testing Amantadine in people with Stroke, Ischemic and Stroke Hemorrhagic, run by University of Pennsylvania at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Ischemic, Stroke Hemorrhagic
- What is being tested?
- Amantadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 30 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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.
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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) -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nichole Gallatti, M.S.Ed. contact
United States1 site, 1 recruiting
- Recruiting
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Nichole Gallatti, nichole.gallatti@penn.medicine.upenn.edu
Scott Kasner, MD
About this study
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.
- Conditions
- Stroke, Ischemic, Stroke Hemorrhagic
- Being tested
- Amantadine, Placebo
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmantadineDrug
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
PlaceboDrug
placebo pills
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo pill, twice daily Receives: Drug: Placebo |
| Amantadine | Active comparator | 100 mg amantadine twice daily, or if 65 years or older once daily Receives: Drug: Amantadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Tolerability of the study drug will be assessed based on the proportion of patients who adherent with at least 80% of study medication.
Measured: Day 90
Secondary outcomes (7)
Global rating on the Stroke Impact Scale (SIS)
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
Measured: 90 days
Total score on the National Institute of Health Stroke Scale (NIHSS)
Assessment for stroke deficits in patients; scores range from 0-42, with a higher score indicating more severe stroke symptoms
Measured: 90 days
Digit Symbol Substitution Test (DSST) score
Cognitive test; scores range from 0 to 100, with higher scores indicating higher cognitive function
Measured: 90 Days
Montreal Cognitive Assessment test (MOCA) score
Cognitive test; scores range from 0 to 30, with higher scores indicating higher cognitive function
Measured: 90 Days
Patient Health Questionnaire (PHQ-9) score
Patient reported survey of depression symptoms; scores range from 0 to 27, with higher scores indicating higher levels of depression
Measured: 90 days
Upper limb strength
The upper limb strength for each subject with be measured using a hand dynamometer
Measured: 90 Days
Modified Rankin Score (mRS)
Assessment of post-stroke recovery; scores range from 0 to 6, with higher scores indicating more severe impairments on daily functioning
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start1 Feb 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Rothstein, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140148
- Sponsor's protocol ID
- 849451
- Acronym
- PRESTA
- Status last verified
- Mar 2026
- First submitted
- 15 Sep 2021
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Recovery After STroke With Amantadine
- ClinicalTrials.gov ID
- NCT05140148
- Acronym / sponsor ID
- PRESTA / 849451
- Conditions
- Stroke, Ischemic, Stroke Hemorrhagic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placeboplacebo pill, twice daily |
| Amantadine | Active comparator | Drug: Amantadine100 mg amantadine twice daily, or if 65 years or older once daily |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmantadineAmantadine 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 | Amantadine |
| Placeboplacebo pills | Drug | Placebo |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke, Ischemic
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
Recruiting
A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
Acute Ischemic Stroke, Acute Haemorrhagic Stroke
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
RecruitingPhase 2
The Efficacy and Safety of HRS-4029 in Acute Ischemic Stroke Patients
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nichole Gallatti, M.S.Ed. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amantadine in people with Stroke, Ischemic and Stroke Hemorrhagic, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aaron Rothstein, M.D (267-624-4442, aaron.rothstein@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.