Promoting Recovery After STroke with Amantadine (PRESTA)

University of Pennsylvania

Status and phase: Enrolling; Phase 2

Conditions: Stroke Hemorrhagic; Stroke, Ischemic

Treatments: Drug: Placebo; Drug: Amantadine

Study type: Interventional

Funder types: Other

Identifiers

NCT05140148

849451

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 to 85 years old, male and female
2. Modified Rankin Score (mRS)<=2 prior to stroke
3. Ischemic or hemorrhagic stroke as diagnosed by vascular neurologist or as proven on magnetic resonance imaging (MRI) or non-contrast head computed tomography NCHCT)
4. 24 hours to 3 weeks after stroke onset or time last known well prior to detection of symptoms
5. National Institute of Health Stroke Scale (NIHSS)>=3 and NIHSS<=15
6. Creatinine Clearance of greater than or equal to 60 mL/min using the Cockroft- Gault equation.
7. Have passed a swallow evaluation prior to drug administration
8. The patient is an acute rehabilitation candidate or candidate for the Homeward Stroke Program
9. Able to participate in administered tests

Exclusion criteria

1. Any degree of receptive aphasia
2. Moderate or severe expressive aphasia
3. Currently pregnant or plans to get pregnant
4. Currently breastfeeding
5. Any patient admitted with primary SubarachnoidH emorrhage (SAH )on either non-contrast head CT or MRI brain
6. Diagnosis of dementia or mild cognitive impairment prior to index stroke
7. Prior limb amputation
8. Currently prescribed or taking a primary anticholinergic medication
9. Currently enrolled in any other investigational pharmacologic or procedural clinical trial
10. Malignancy with active treatment
11. History of prior stroke with residual impairment
12. Current or prior neuroleptic use
13. 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)
14. Prior history of seizures
15. Prior treatment with amantadine
16. Parkinson's disease
17. Amantadine allergy
18. Elevated liver function tests (aspartate aminotransferase and alanine aminotransferase above the upper limit of normal) -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

placebo pill, twice daily

Treatment:

Drug: Placebo

Amantadine

Active Comparator group

Description:

100 mg amantadine twice daily, or if 65 years or older once daily

Treatment:

Drug: Amantadine