Promoting Recovery After STroke With Amantadine

Stroke, Ischemic Clinical Trial

— PRESTA  

Official title:

Promoting Recovery After STroke With Amantadine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05140148
• Other study ID #: 849451
• Status: Recruiting
• Phase: Phase 2
• Start date: February 1, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: February 2024
• Source: University of Pennsylvania
• Contact: Aaron Rothstein, M.D
• Phone: 267-624-4442
• Email: aaron.rothstein[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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) -

Related Conditions & MeSH terms

• Hemorrhagic Stroke
• Ischemic Stroke
• Stroke
• Stroke Hemorrhagic
• Stroke, Ischemic

Intervention

Drug:
• Amantadine
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
placebo pills

Locations

Country	Name	City	State
United States	The Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 90
Secondary	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	90 days
Secondary	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	90 days
Secondary	Digit Symbol Substitution Test (DSST) score	Cognitive test; scores range from 0 to 100, with higher scores indicating higher cognitive function	90 Days
Secondary	Montreal Cognitive Assessment test (MOCA) score	Cognitive test; scores range from 0 to 30, with higher scores indicating higher cognitive function	90 Days
Secondary	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	90 days
Secondary	Upper limb strength	The upper limb strength for each subject with be measured using a hand dynamometer	90 Days
Secondary	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	90 days